These Highlights Do Not Include All The Information Needed To Use Zepbound Safely And Effectively. See Full Prescribing Information For Zepbound.

Limitations of Use

ZEPBOUND contains tirzepatide. Coadministration with other tirzepatide-containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.

PACKAGE LABEL – ZEPBOUND KwikPen – 2.5 mg per dose (10 mg/2.4 mL [4.17 mg/mL])

NDC 0002-3566-11

Rx Only

Zepbound^®

KwikPen^®

(tirzepatide) injection

2.5 mg per dose

10 mg/2.4 mL (4.17 mg/mL)

1 Pen with 4 doses of 2.5 mg

TURN THE DOSE KNOB ALL THE WAY UNTIL YOU SEE A

For Single-Patient-Use Only

For Subcutaneous Use

Needles not included

Dispense enclosed Medication Guide to each patient.

Use ZEPBOUND KwikPen once weekly

Read the INSTRUCTIONS FOR USE. This product may have different steps than other products.

In the event of an overdosage, contact the Poison Help Line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. Appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms. A period of observation and treatment for these symptoms may be necessary, taking into account the half-life of tirzepatide of approximately 5 days.

ZEPBOUND (tirzepatide) injection, for subcutaneous use, contains tirzepatide, a GIP receptor and GLP-1 receptor agonist. Tirzepatide is based on the GIP sequence and contains aminoisobutyric acid (Aib) in positions 2 and 13, a C-terminal amide, and Lys residue at position 20 that is attached to 1,20-eicosanedioic acid via a linker. The molecular weight is 4813.53 Da and the empirical formula is C₂₂₅H₃₄₈N₄₈O₆₈.

Structural formula:

ZEPBOUND is a clear, colorless to slightly yellow, sterile solution for subcutaneous use. Each single-dose pen or single-dose vial contains a 0.5 mL solution of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide and the following excipients: sodium chloride (4.1 mg), sodium phosphate dibasic heptahydrate (0.7 mg), and water for injection. Each multi-dose vial or single-patient-use KwikPen contains 2.4 mL of solution, which provides 4 doses of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide per 0.6 mL. Each dose contains the following excipients: benzyl alcohol (5.4 mg), glycerin (4.8 mg), phenol (1.08 mg), sodium chloride (1.05 mg), sodium phosphate dibasic heptahydrate (0.8 mg), and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH. ZEPBOUND has a pH of 6.5 to 7.5.

Each single-patient-use KwikPen contains additional volume to allow for device priming.

ZEPBOUND lowers blood glucose and can cause hypoglycemia.

In a trial of patients with type 2 diabetes mellitus and BMI ≥27 kg/m² (Study 2), hypoglycemia (plasma glucose <54 mg/dL) was reported in 4.2% of ZEPBOUND-treated patients versus 1.3% of placebo-treated patients. In this trial, patients taking ZEPBOUND in combination with an insulin secretagogue (e.g., sulfonylurea) had increased risk of hypoglycemia (10.3%) compared to ZEPBOUND-treated patients not taking a sulfonylurea (2.1%). There is also increased risk of hypoglycemia in patients treated with tirzepatide in combination with insulin [see Drug Interactions (7.1)].

Hypoglycemia has also been associated with ZEPBOUND and GLP-1 receptor agonists in adults without type 2 diabetes mellitus [see Adverse Reactions (6.1)].

Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. In patients with diabetes mellitus, monitor blood glucose prior to starting ZEPBOUND and during ZEPBOUND treatment. The risk of hypoglycemia may be lowered by a reduction in the dose of insulin or sulfonylurea (or other concomitantly administered insulin secretagogue).

ZEPBOUND (tirzepatide) is a clear, colorless to slightly yellow solution available in cartons containing 4 pre-filled single-dose pens, 1 single-dose vial, 4 single-dose vials, 1 multi-dose vial, or 1 single-patient-use KwikPen as follows:

The safety and effectiveness of ZEPBOUND have not been established in pediatric patients.

In a pool of two fixed dose ZEPBOUND clinical studies for weight reduction (Study 1 and Study 2), 226 (9%) ZEPBOUND-treated patients were 65 years of age or older, and 13 (0.5%) ZEPBOUND-treated patients were 75 years of age or older at baseline.

No overall differences in safety or effectiveness of ZEPBOUND have been observed between patients 65 years of age and older and younger adult patients.

ZEPBOUND clinical studies in OSA (Study 5 and Study 6) did not include sufficient numbers of patients age 65 years or older to determine whether they respond differently from younger adult patients. Other reported clinical experience with tirzepatide has not identified differences in responses between the elderly and younger patients.

The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies.

The incidence of anti-drug antibodies (ADA) to ZEPBOUND was evaluated in adult patients with overweight or obesity or with OSA and obesity in clinical studies lasting 52 weeks or longer. Anti-tirzepatide antibodies were detected in 64.5% (1591/2467) of ZEPBOUND-treated patients in weight reduction clinical studies 1 and 2, and 60.6% (137/226) of ZEPBOUND-treated patients in OSA clinical studies [see Clinical Studies (14)].

Of the ZEPBOUND-treated patients in weight reduction clinical studies 40% and 16.5% of patients developed antibodies that were cross-reactive to native GIP or native GLP-1, respectively.

Of the ZEPBOUND-treated patients in OSA clinical studies, 37.2% and 19.5% of patients developed antibodies that were cross reactive to native GIP and native GLP-1, respectively.

Neutralizing antibodies against tirzepatide activity on the GIP or GLP-1 receptors and against native GIP or GLP-1 were detected in 2.8% and 2.7% and 0.8% and 0.1% respectively, of ZEPBOUND-treated patients in weight reduction clinical studies.

No ZEPBOUND-treated patients in OSA studies developed neutralizing antibodies against tirzepatide activity on the GIP or GLP-1 receptors or against native GIP or native GLP-1.

No clinically significant effect of anti-tirzepatide antibodies on pharmacokinetics or effectiveness of ZEPBOUND has been identified. More ZEPBOUND-treated patients who developed anti-tirzepatide antibodies experienced hypersensitivity reactions or injection site reactions than those who did not develop these antibodies [see Adverse Reactions (6.1)].

ZEPBOUND is contraindicated in patients with:

• A personal or family history of MTC or in patients with MEN 2 [see Warnings and Precautions (5.1)].
• Known serious hypersensitivity to tirzepatide or any of the excipients in ZEPBOUND. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with tirzepatide [see Warnings and Precautions (5.6) and Adverse Reactions (6.2)].

The following serious adverse reactions are described below or elsewhere in the prescribing information:

• Risk of Thyroid C-cell Tumors [see Warnings and Precautions (5.1)]
• Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.2)]
• Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions (5.3)]
• Acute Gallbladder Disease [see Warnings and Precautions (5.4)]
• Acute Pancreatitis [see Warnings and Precautions (5.5)]
• Hypersensitivity Reactions [see Warnings and Precautions (5.6)]
• Hypoglycemia [see Warnings and Precautions (5.7)]
• Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus [see Warnings and Precautions (5.8)]
• Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions (5.9)]

ZEPBOUND delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. (7.2)

ZEPBOUND delays gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with ZEPBOUND.

Monitor patients on oral medications dependent on threshold concentrations for efficacy and those with a narrow therapeutic index (e.g., warfarin) when concomitantly administered with ZEPBOUND.

Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation with ZEPBOUND and for 4 weeks after each dose escalation. Hormonal contraceptives that are not administered orally should not be affected [see Use in Specific Populations (8.3) and Clinical Pharmacology (12.2, 12.3)].

No dosage adjustment of ZEPBOUND is recommended for patients with renal impairment. In subjects with renal impairment including end-stage renal disease (ESRD), no change in tirzepatide pharmacokinetics (PK) was observed [see Clinical Pharmacology (12.3)]. Monitor renal function in patients reporting adverse reactions to ZEPBOUND that could lead to volume depletion [see Warnings and Precautions (5.3)].

Tirzepatide lowers body weight with greater fat mass loss than lean mass loss.

Tirzepatide decreases calorie intake. The effects are likely mediated by affecting appetite.

Tirzepatide stimulates insulin secretion in a glucose-dependent manner and reduces glucagon secretion. Tirzepatide increases insulin sensitivity, as demonstrated in a hyperinsulinemic euglycemic clamp study in patients with type 2 diabetes mellitus after 28 weeks of treatment. These effects can lead to a reduction of blood glucose.

Tirzepatide delays gastric emptying. The delay is largest after the first dose and this effect diminishes over time.

The pharmacokinetics of tirzepatide is similar between healthy subjects, patients with overweight or obesity, and patients with OSA and obesity. Steady-state plasma tirzepatide concentrations were achieved following 4 weeks of once weekly administration. Tirzepatide exposure increases in a dose-proportional manner.

Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, or ZEPBOUND [see Adverse Reactions (6)].

After initiation of ZEPBOUND, observe patients carefully for signs and symptoms of acute pancreatitis which may include persistent or severe abdominal pain (sometimes radiating to the back) and which may or may not be accompanied by nausea or vomiting. If pancreatitis is suspected, discontinue ZEPBOUND and initiate appropriate management.

No dosage adjustment of ZEPBOUND is recommended for patients with hepatic impairment. In a clinical pharmacology study in subjects with varying degrees of hepatic impairment, no change in tirzepatide PK was observed [see Clinical Pharmacology (12.3)].

ZEPBOUND^® is indicated in combination with a reduced-calorie diet and increased physical activity:

• to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.
• to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity.

Tirzepatide is a GIP receptor and GLP-1 receptor agonist. It contains a C20 fatty diacid that enables albumin binding and prolongs the half-life. Tirzepatide selectively binds to and activates both the GIP and GLP-1 receptors, the targets for native GIP and GLP-1.

GLP-1 is a physiological regulator of appetite and caloric intake. Nonclinical studies suggest the addition of GIP may further contribute to the regulation of food intake.

Both GIP receptors and GLP-1 receptors are found in areas of the brain involved in appetite regulation. Animal studies show that tirzepatide distributes to and activates neurons in brain regions involved in regulation of appetite and food intake.

ZEP-0008-MG-20260225

• Do not freeze ZEPBOUND. Do not use ZEPBOUND if frozen.
• Protect ZEPBOUND from heat and light.
• Store ZEPBOUND in the original carton to protect from light.

ZEPBOUND Single-dose Pen and Single-dose Vial

• Store ZEPBOUND single-dose pen and single-dose vial in a refrigerator at 2°C to 8°C (36°F to 46°F).
• If needed, each single-dose pen or single-dose vial can be stored unrefrigerated at temperatures not to exceed 30°C (86°F) for up to 21 days. If single-dose pen or single-dose vial is stored at room temperature, it should not be returned to the refrigerator.
• Discard single-dose pen and single-dose vial if not used within 21 days after removing from the refrigerator.

ZEPBOUND Multi-dose Vial or Single-Patient-Use KwikPen

Unopened vial or single-patient-use KwikPen:

• Store unopened multi-dose vial or single-patient-use KwikPen in the refrigerator at 2°C to 8°C (36°F to 46°F). The unopened multi-dose vial or single-patient-use KwikPen can be used until the expiration date on the label if kept in the refrigerator.
• If stored at room temperature [up to 30°C (86°F)], throw away unopened multi-dose vial or single-patient-use KwikPen after 30 days.

After vial or single-patient-use KwikPen has been opened:

• Store opened (in-use) multi-dose vial or single-patient-use KwikPen in the original carton in the refrigerator at 2°C to 8°C (36°F to 46°F) or at room temperature [up to 30°C (86°F)].
• Throw away opened multi-dose vial or single-patient-use KwikPen after a total of 30 days at room temperature, 30 days after first use, or after taking 4 weekly doses, even if there is medicine left in it.

• Severe Gastrointestinal Adverse Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. ZEPBOUND is not recommended in patients with severe gastroparesis. (5.2)
• Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. (5.3)
• Acute Gallbladder Disease: Has been reported in clinical trials. If cholecystitis is suspected, gallbladder studies and clinical follow-up are indicated. (5.4)
• Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, or ZEPBOUND. Discontinue if pancreatitis is suspected. (5.5)
• Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported postmarketing with tirzepatide. If suspected, advise patients to promptly seek medical attention and discontinue ZEPBOUND. (5.6)
• Hypoglycemia: Concomitant use with insulin or an insulin secretagogue may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing dose of insulin or insulin secretagogue may be necessary. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. (5.7)
• Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus: Has not been studied in patients with non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema. Monitor patients with a history of diabetic retinopathy for progression. (5.8)
• Pulmonary Aspiration During General Anesthesia or Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures. (5.9)
• Never share a ZEPBOUND KwikPen between patients, even if the pen needle is changed. (5.10)

Recommended Dose Escalation Schedule

• The recommended starting dosage is 2.5 mg injected subcutaneously once weekly for 4 weeks. Increase the dosage in 2.5 mg increments after at least 4 weeks until recommended maintenance dosage is achieved. (2.1)
• Consider treatment response and tolerability when selecting the maintenance dosage. (2.1)

Recommended Maintenance and Maximum Dosage

• Weight Reduction and Long-Term Maintenance: 5 mg, 10 mg, or 15 mg injected subcutaneously once weekly. (2.2)
• Obstructive Sleep Apnea: 10 mg or 15 mg injected subcutaneously once weekly. (2.2)

Maximum Recommended Dosage: 15 mg injected subcutaneously once weekly. (2.2)

Administration Instructions

Refer to the Full Prescribing Information for additional important administration instructions about ZEPBOUND presentations. (2.4)

Injection: Clear, colorless to slightly yellow solution in pre-filled single-dose pens, single-dose vials, multi-dose vials, or single-patient-use KwikPens, each available in the following strengths. The multi-dose vials and single-patient-use KwikPen each contain 4 doses:

The following adverse reactions have been reported during post-approval use of tirzepatide, the active ingredient in ZEPBOUND. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure.

Gastrointestinal: acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death, ileus, intestinal obstruction, severe constipation including fecal impaction

Hypersensitivity: anaphylaxis, angioedema

Pulmonary: Pulmonary aspiration has occurred in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation.

Renal: acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis

Treatment with ZEPBOUND and GLP-1 receptor agonists is associated with an increased occurrence of acute gallbladder disease.

In a pool of two ZEPBOUND clinical trials for weight reduction (Studies 1 and 2), cholelithiasis was reported in 1.1% of ZEPBOUND-treated patients and 1% of placebo-treated patients, cholecystitis was reported in 0.7% of ZEPBOUND-treated patients and 0.2% of placebo-treated patients, and cholecystectomy was reported in 0.2% of ZEPBOUND-treated patients and no placebo-treated patients. Acute gallbladder events were associated with weight reduction. Similar rates of cholelithiasis were reported in ZEPBOUND clinical trials for weight reduction and in ZEPBOUND trials for OSA. If cholecystitis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated.

• Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue ZEPBOUND. (8.1)
• Females of Reproductive Potential: Advise females using oral contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation. (8.3)

There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) in patients treated with tirzepatide. In a pool of two ZEPBOUND clinical studies for weight reduction (Studies 1 and 2), 0.1% of ZEPBOUND-treated patients had severe hypersensitivity reactions compared to no placebo-treated patients. Similar rates of severe hypersensitivity reactions were observed in ZEPBOUND clinical trials for weight reduction and in ZEPBOUND trials for OSA. If hypersensitivity reactions occur, advise patients to promptly seek medical attention and discontinue use of ZEPBOUND. Do not use in patients with a previous serious hypersensitivity reaction to tirzepatide or any of the excipients in ZEPBOUND [see Contraindications (4) and Adverse Reactions (6.2)].

Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with GLP-1 receptor agonists. Use caution in patients with a history of angioedema or anaphylaxis with a GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to these reactions with ZEPBOUND.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

In rats, tirzepatide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) in a 2-year study at clinically relevant plasma exposures [see Nonclinical Toxicology (13.1)]. It is unknown whether ZEPBOUND causes thyroid C-cell tumors, including MTC, in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined.

ZEPBOUND is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of ZEPBOUND and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).

Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with ZEPBOUND. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.

Important information you need to know before injecting ZEPBOUND

Read this Instructions for Use and the Medication Guide before using your ZEPBOUND pen and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Talk to your healthcare provider about how to inject ZEPBOUND the right way.

• ZEPBOUND is a single-dose prefilled pen.
• ZEPBOUND is used 1 time each week.
• Inject under the skin (subcutaneously) only.
• You or another person can inject into your stomach (abdomen) or thigh.
• Another person can inject into the back of your upper arm.

Guide to parts

Preparing to inject ZEPBOUND

Disposing of your used pen

• Put your used pen in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) pens in your household trash.
• If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
  • -
    made of a heavy-duty plastic,
  • -
    can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • -
    upright and stable during use,
  • -
    leak-resistant, and
  • -
    properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
• Do not recycle your used sharps disposal container.

Storage and handling

• Store your pen in the refrigerator between 36°F to 46°F (2°C to 8°C).
• You may store your pen at room temperature up to 86°F (30°C) for up to 21 days. If you store the pen at room temperature, do not return the pen to the refrigerator.
• Discard the pen if not used within 21 days after removing from the refrigerator.
• Do not freeze your pen. If the pen has been frozen, throw the pen away and use a new pen.
• Store your pen in the original carton to protect your pen from light.
• The pen has glass parts. Handle it carefully. If you drop the pen on a hard surface, do not use it. Use a new pen for your injection.
• Keep your ZEPBOUND pen and all medicines out of the reach of children.

Commonly asked questions

What if I see air bubbles in my pen?

Air bubbles are normal.

What if my pen is not at room temperature?

It is not necessary to warm the pen to room temperature.

What if I unlock the pen and press the purple injection button before pulling off the gray base cap?

Do not remove the gray base cap. Throw away the pen and get a new pen.

What if there is a drop of liquid on the tip of the needle when I remove the gray base cap?

A drop of liquid on the tip of the needle is normal. Do not touch the needle.

Do I need to hold the injection button down until the injection is complete?

This is not necessary, but it may help you keep the pen steady against your skin.

I heard more than 2 clicks during my injection—2 loud clicks and 1 soft one. Did I get my complete injection?

Some people may hear a soft click right before the second loud click. That is the normal operation of the pen. Do not remove the pen from your skin until you hear the second loud click.

I am not sure if my pen worked the right way.

What if there is a drop of liquid or blood on my skin after my injection?

This is normal. Press a cotton ball or gauze over the injection site. Do not rub the injection site.

Other information

• If you have vision problems, do not use your pen without help from a person trained to use the ZEPBOUND pen.

Where to learn more

• If you have questions or problems with your ZEPBOUND pen, contact Lilly at 1-800-Lilly-Rx (1-800-545-5979) or call your healthcare provider.
• For more information about the ZEPBOUND pen, visit our website at www.zepbound.com.

Marketed by:

Lilly USA, LLC

Indianapolis, IN 46285, USA

ZEPBOUND is a trademark of Eli Lilly and Company.

Copyright © 2023, Eli Lilly and Company. All rights reserved.

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised: November 2023

ZEP-0002-PEN-IFU-20231109

Important information you need to know before injecting ZEPBOUND

Read this Instructions for Use before you start taking ZEPBOUND and each time you get a new vial. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Do not share your needles or syringes with other people. You may give other people a serious infection or get a serious infection from them.

Talk to your healthcare provider about how to inject ZEPBOUND the right way.

• ZEPBOUND is a single-dose vial.
• ZEPBOUND is used 1 time each week.
• Inject under the skin (subcutaneously) only.
• You or another person may inject into your stomach (abdomen) or thigh.
• Another person can inject into the back of your upper arm.

Gather supplies needed to give your injection

• 1 single-dose ZEPBOUND vial
• 1 syringe and 1 needle, supplied separately (for example, use a 1 mL syringe and needle as recommended by your healthcare provider)
• 1 alcohol swab
• gauze
• 1 sharps container for throwing away used needles and syringes. See “Disposing of used needles and syringes” at the end of these instructions.

Note: The needle and syringe are not included. The needle and syringe recommended by your healthcare provider may look different than the needle and syringe in this Instructions for Use.

Preparing to inject ZEPBOUND

Remove the vial from the refrigerator.

Check the vial label to make sure you have the right medicine and dose, and that it has not expired.

Make sure the medicine:

Always use a new syringe and needle for each injection to prevent infections and blocked needles. Do not reuse or share your syringes or needles with other people. You may give other people a serious infection or get a serious infection from them.

Wash your hands with soap and water.

Injecting ZEPBOUND

• Inject exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you should pinch the skin before injecting.
• Change (rotate) your injection site within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
• Do not inject where the skin has pits, is thickened, or has lumps.
• Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
• Do not mix ZEPBOUND with any other medicine.
• Do not inject ZEPBOUND in the same injection site used for other medicines.

Disposing of used needles and syringes

• Put your used needle and syringe in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.
• If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
  • -
    made of a heavy-duty plastic,
  • -
    can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • -
    upright and stable during use,
  • -
    leak-resistant, and
  • -
    properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at:
  
  http://www.fda.gov/safesharpsdisposal.
• Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

Storing ZEPBOUND

• Store all unopened vials in the refrigerator at 36°F to 46°F (2°C to 8°C).
• You may store the unopened vial at room temperature up to 86°F (30°C) for up to 21 days.
• Do not freeze. Do not use if ZEPBOUND has been frozen.
• Store the vial in the original carton to protect from light.
• Throw away all opened vials after use, even if there is medicine left in the vial.

Keep ZEPBOUND vials, syringes, needles, and all medicines out of the reach of children.

If you have any questions or problems with your ZEPBOUND, contact Lilly at 1-800-Lilly-Rx (1-800-545-5979) or call your healthcare provider for help.

Marketed by:

Lilly USA, LLC

Indianapolis, IN 46285, USA

ZEPBOUND is a registered trademark of Eli Lilly and Company.

Copyright © 2024, Eli Lilly and Company. All rights reserved.

ZEP-0001-VL-IFU-20240328

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Issued: March 2024

• In rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether ZEPBOUND causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions (5.1) and Nonclinical Toxicology (13.1)].
• ZEPBOUND is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications (4)] . Counsel patients regarding the potential risk for MTC with the use of ZEPBOUND and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with ZEPBOUND [see Contraindications (4) and Warnings and Precautions (5.1)].

INSTRUCTIONS FOR USE

ZEPBOUND ^® [ZEHP-bownd] KwikPen ^® [KWIHK pehn]

(tirzepatide)

injection, for subcutaneous use

multi-dose single-patient-use prefilled pen

Each pen contains 4 fixed doses, one dose taken weekly.

This Instructions for Use contains information on how to inject ZEPBOUND.

Read this INSTRUCTIONS FOR USE before you start injecting ZEPBOUND KwikPen (Pen) and each time you get another new Pen. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

• ZEPBOUND KwikPen is a disposable multi-dose single-patient-use prefilled pen. The Pen contains 4 fixed doses, one dose taken weekly. Inject in a single weekly injection, under the skin (subcutaneously).

• For your weekly dose, you need to turn the dose knob all the way until it stops AND the

  icon is in dose window.

• After 4 doses, throw away (discard) the Pen, including the unused medicine. The Pen will prevent you from dialing a full dose after you have given yourself 4 weekly doses. Do not inject the leftover medicine. Do not transfer ZEPBOUND from your Pen into a syringe.
• Do not share your ZEPBOUND Pen with other people, even if the pen needle has been changed. You may give other people a serious infection or get a serious infection from them.
• People who are blind or have vision problems should not use the Pen without help from a person trained to use the Pen.

Parts of the ZEPBOUND Pen

Unused Pens:

• Store unused Pens in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Unused Pens may be used until the expiration date (EXP) printed on the label if the Pen has been kept in the refrigerator.
• Do not freeze your Pen. Throw away (discard) the Pen if it has been frozen.

Used Pens:

• You may store your used Pen at room temperature up to 86°F (30°C) after your injection.
• Keep away from heat and light.
• Keep your Pen and needles out of the sight and reach of children.
• Throw away the Pen 30 days after first use even though the Pen has medicine left in it.
• Throw away the Pen after receiving 4 weekly doses. Attempting to inject any leftover medicine could result in an incomplete dose even though the Pen still has medicine left in it.

• Put your used pen needles in an FDA-cleared sharps disposal container right away after use.
• Do not throw away (discard) loose pen needles in your household trash.
• Discard the used Pen in your household trash or FDA-cleared sharps disposal container after you have removed the needle.
• If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
  • –
    made of a heavy-duty plastic,
  • –
    can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • –
    upright and stable during use,
  • –
    leak-resistant, and
  • –
    properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away (discard) used needles. For more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
• Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

• If you cannot remove the Pen cap, gently twist the Pen cap back and forth, and then pull the Pen cap straight off.
• If the dose knob is hard to push:
  • –
    pushing the dose knob more slowly will make it easier to inject.
  • –
    your needle may be blocked. Put on a new pen needle and prime the Pen.
  • –
    you may have dust, food, or liquid inside the Pen. Throw the Pen away and get a new Pen.

• If the Pen prevents you from turning the dose knob until the

  is in the dose window:
  • –
    Throw away (discard) the Pen, including the unused medicine. There may not be enough medicine left in the pen to give a full dose. Do not attempt to inject the leftover medicine.

Additional Information:

If you have any questions or problems with ZEPBOUND KwikPen:

ZEPBOUND^® and KwikPen^® are registered trademarks of Eli Lilly and Company.

Marketed by:

Lilly USA, LLC

Indianapolis, IN 46285, USA

Copyright © 2026, Eli Lilly and Company. All rights reserved.

ZEPBOUND KwikPen meets the current dose accuracy and functional requirements of ISO 11608-1.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: January 2026

ZEPKP-0002-IFU-20260121

INSTRUCTIONS FOR USE

ZEPBOUND^® [ZEHP-bownd]

(tirzepatide)

injection, for subcutaneous use

Multi-dose vial

Each vial contains 4 doses, one dose taken weekly.

Important information you need to know before injecting ZEPBOUND

Read this Instructions for Use before you start taking ZEPBOUND and each time you get a new vial. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Do not share your needles or syringes with other people.

Talk to your healthcare provider about how to inject ZEPBOUND the right way.

• ZEPBOUND is a multi-dose vial. The vial contains 4 doses, one dose taken weekly.
• Inject 0.6 mL in a single weekly injection, under the skin (subcutaneously).
• You or another person may inject into your stomach (abdomen) or thigh.
• Another person can inject into the back of your upper arm.

Gather supplies needed to give your injection

• 1 multi-dose ZEPBOUND vial
• 1 syringe and 1 needle, supplied separately (for example, use a 1 mL syringe and needle as recommended by your healthcare provider)
• 1 alcohol swab
• gauze
• 1 sharps container for throwing away used needles and syringes. See “Disposing of used needles and syringes” at the end of these instructions.

Note: The needle and syringe are not included. The needle and syringe recommended by your healthcare provider may look different than the needle and syringe in this Instructions for Use.

Preparing to inject ZEPBOUND

Check the vial label to make sure you have the right medicine and dose, and that it has not expired.

Make sure the medicine:

Always use a new syringe and needle for each injection to prevent infections and blocked needles. Do not reuse or share your syringes or needles with other people. You may give other people a serious infection or get a serious infection from them.

Wash your hands with soap and water.

Injecting ZEPBOUND

• Inject exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you should pinch the skin before injecting.
• Change (rotate) your injection site within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
• Do not inject where the skin has pits, is thickened, or has lumps.
• Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
• Do not mix ZEPBOUND with any other medicine.
• Do not inject ZEPBOUND in the same injection site used for other medicines.

Disposing of used needles and syringes

• Put your used needle and syringe in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.
• If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
  • -
    made of a heavy-duty plastic,
  • -
    can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • -
    upright and stable during use,
  • -
    leak-resistant, and
  • -
    properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at:
  
  http://www.fda.gov/safesharpsdisposal.
• Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

Storing ZEPBOUND

• Do not freeze. Do not use if ZEPBOUND has been frozen.
• Store ZEPBOUND in original carton. Keep away from light.

Unopened vial:

• Store unopened vial in the refrigerator at 36°F to 46°F (2°C to 8°C). It can be used until the expiration date on the label if kept in the refrigerator.
• If stored at room temperature [up to 86°F (30°C)], throw away unopened vial after 30 days.

After vial has been opened:

• Store opened (in-use) vial in the original carton in the refrigerator at 36°F to 46°F (2°C to 8°C) or at room temperature [up to 86°F (30°C)]. Throw away opened vial after a total of 30 days at room temperature, 30 days after first use, or after taking 4 weekly doses, even if there is medicine left in it.

Keep ZEPBOUND vials, syringes, needles, and all medicines out of the reach of children.

If you have any questions or problems with your ZEPBOUND, contact Lilly at 1-800-Lilly-Rx (1-800-545-5979) or call your healthcare provider for help.

Marketed by:

Lilly USA, LLC

Indianapolis, IN 46285, USA

ZEPBOUND is a registered trademark of Eli Lilly and Company.

Copyright © 2026, Eli Lilly and Company. All rights reserved.

ZEP-0001-MDV-IFU-20260107

This Instructions for Use has been approved by the U.S. Food and Drug Administration .

Revised: January 2026

• The recommended starting dosage of ZEPBOUND for all indications is 2.5 mg injected subcutaneously once weekly for 4 weeks.
• The 2.5 mg dosage is for treatment initiation and is not approved as a maintenance dosage.
• Follow the dosage escalation below for all indications to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].
• After 4 weeks, increase the dosage to 5 mg injected subcutaneously once weekly. The dosage may be increased in 2.5 mg increments, after at least 4 weeks on the current dose [see Dosage and Administration (2.2)].
• Consider treatment response and tolerability when selecting the maintenance dosage. If patients do not tolerate a maintenance dosage, consider a lower maintenance dosage.

• If a dose is missed, instruct patients to administer ZEPBOUND as soon as possible within 4 days (96 hours) after the missed dose. If more than 4 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.
• The day of weekly administration can be changed, if necessary, as long as the time between the two doses is at least 3 days (72 hours).

• Inform patients and their caregiver(s) which ZEPBOUND presentation (e.g., vial, prefilled single-dose pen, single-patient-use KwikPen) they will receive and ensure they receive training appropriate for that specific presentation. If the prescribed ZEPBOUND presentation changes, ensure patients and caregivers receive appropriate training and instruct them to consult the Instructions for Use for the newly prescribed presentation.
• Prior to initiation, train patients and their caregiver(s) on proper injection technique for the prescribed ZEPBOUND presentation [see Instructions for Use]. After training, a patient may self-inject ZEPBOUND if the healthcare provider determines that it can be properly administered, except for the following:
  • ZEPBOUND KwikPen is not recommended for self-administration by those who are visually impaired.
• Instruct patients using ZEPBOUND vials to use a syringe appropriate for dose administration (e.g., a 1 mL syringe capable of measuring a 0.5 mL or 0.6 mL dose) and always use a new syringe and needle for each injection.
• Inspect ZEPBOUND visually before use. It should appear clear and colorless to slightly yellow. Do not use ZEPBOUND if particulate matter or discoloration is seen.
• Administer ZEPBOUND in combination with a reduced-calorie diet and increased physical activity.
• Administer ZEPBOUND once weekly at any time of day, with or without meals.
• Inject ZEPBOUND subcutaneously in the abdomen, thigh, or another person should inject in the back of the upper arm.
• Rotate injection sites with each dose.

Use of ZEPBOUND has been associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions (6)]. In a pool of two ZEPBOUND clinical trials for weight reduction (Studies 1 and 2), severe gastrointestinal adverse reactions were reported more frequently among patients receiving ZEPBOUND (5 mg 1.7%, 10 mg 2.5%, 15 mg 3.1%) than placebo (1%). Similar rates of severe gastrointestinal adverse reactions were observed in ZEPBOUND clinical trials for weight reduction and in ZEPBOUND clinical trials for OSA. Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists.

ZEPBOUND is not recommended in patients with severe gastroparesis.

There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with GLP-1 receptor agonists, or ZEPBOUND [see Adverse Reactions (6.2)]. The majority of the reported events occurred in patients who experienced gastrointestinal adverse reactions leading to dehydration such as nausea, vomiting, or diarrhea [see Adverse Reactions (6.1)]. Monitor renal function in patients reporting adverse reactions to ZEPBOUND that could lead to volume depletion, especially during dosage initiation and escalation of ZEPBOUND.

A 2-year carcinogenicity study was conducted with tirzepatide in male and female rats at doses of 0.15, 0.50, and 1.5 mg/kg (0.1-, 0.4-, and 1-fold the MRHD of 15 mg once weekly based on AUC) administered by subcutaneous injection twice weekly. A statistically significant increase in thyroid C-cell adenomas was observed in male rats (≥0.5 mg/kg) and female rats (≥0.15 mg/kg), and a statistically significant increase in thyroid C-cell adenomas and carcinomas combined was observed in male and female rats at all doses examined. In a 6-month carcinogenicity study in rasH2 transgenic mice, tirzepatide at doses of 1, 3, and 10 mg/kg administered by subcutaneous injection twice weekly was not tumorigenic.

Tirzepatide was not genotoxic in a rat bone marrow micronucleus assay.

In fertility and early embryonic development studies, male and female rats were administered twice weekly subcutaneous doses of 0.5, 1.5, or 3 mg/kg (0.3-, 1-, and 2-fold and 0.3-, 0.9-, and 2-fold, respectively, the MRHD of 15 mg once weekly based on AUC). No effects of tirzepatide were observed on sperm morphology, mating, fertility, and conception. In female rats, an increase in the number of females with prolonged diestrus and a decrease in the mean number of corpora lutea resulting in a decrease in the mean number of implantation sites and viable embryos was observed at all dose levels. These effects were considered secondary to the pharmacological effects of tirzepatide on food consumption and body weight.

NDC 0002-0243-04

Zepbound^®

(tirzepatide) injection

5 mg/0.5 mL

Rx Only

For Subcutaneous Use

Needles and Syringes are not included

Dispense enclosed Medication Guide to each patient.

Use one vial every week.

4 Single-dose vials

Discard unused portion

Lilly

NDC 0002-1340-04

Zepbound^®

(tirzepatide) injection

10 mg/0.5 mL

Rx Only

For Subcutaneous Use

Needles and Syringes are not included

Dispense enclosed Medication Guide to each patient.

Use one vial every week.

4 Single-dose vials

Discard unused portion

Lilly

NDC 0002-2002-04

Zepbound^®

(tirzepatide) injection

15 mg/0.5 mL

Rx Only

For Subcutaneous Use

Needles and Syringes are not included

Dispense enclosed Medication Guide to each patient.

Use one vial every week.

4 Single-dose vials

Discard unused portion

Lilly

NDC 0002-0152-04

Zepbound^®

(tirzepatide) injection

2.5 mg/0.5 mL

Rx Only

For Subcutaneous Use

Needles and Syringes are not included

Dispense enclosed Medication Guide to each patient.

Use one vial every week.

4 Single-dose vials

Discard unused portion

Lilly

NDC 0002-1214-04

Zepbound^®

(tirzepatide) injection

7.5 mg/0.5 mL

Rx Only

For Subcutaneous Use

Needles and Syringes are not included

Dispense enclosed Medication Guide to each patient.

Use one vial every week.

4 Single-dose vials

Discard unused portion

Lilly

NDC 0002-1423-04

Zepbound^®

(tirzepatide) injection

12.5 mg/0.5 mL

Rx Only

For Subcutaneous Use

Needles and Syringes are not included

Dispense enclosed Medication Guide to each patient.

Use one vial every week.

4 Single-dose vials

Discard unused portion

Lilly

ZEPBOUND delays gastric emptying [see Clinical Pharmacology (12.2)]. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations.

Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking ZEPBOUND, including whether modifying preoperative fasting recommendations or temporarily discontinuing ZEPBOUND could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking ZEPBOUND.

NDC 0002-2495-80

Zepbound^®

(tirzepatide) injection

5 mg/0.5 mL

4 x 5 mg/0.5 mL prefilled pens

Rx Only

For Subcutaneous Use

Dispense enclosed Medication Guide to each patient.

Use one pen every week.

4 Single-dose prefilled pens

Lilly

NDC 0002-2471-80

Zepbound^®

(tirzepatide) injection

10 mg/0.5 mL

4 x 10 mg/0.5 mL prefilled pens

Rx Only

For Subcutaneous Use

Dispense enclosed Medication Guide to each patient.

Use one pen every week.

4 Single-dose prefilled pens

Lilly

NDC 0002-2457-80

Zepbound^®

(tirzepatide) injection

15 mg/0.5 mL

4 x 15 mg/0.5 mL prefilled pens

Rx Only

For Subcutaneous Use

Dispense enclosed Medication Guide to each patient.

Use one pen every week.

4 Single-dose prefilled pens

Lilly

NDC 0002-2506-80

Zepbound^®

(tirzepatide) injection

2.5 mg/0.5 mL

4 x 2.5 mg/0.5 mL prefilled pens

Rx Only

For Subcutaneous Use

Dispense enclosed Medication Guide to each patient.

Use one pen every week.

4 Single-dose prefilled pens

Lilly

NDC 0002-2484-80

Zepbound^®

(tirzepatide) injection

7.5 mg/0.5 mL

4 x 7.5 mg/0.5 mL prefilled pens

Rx Only

For Subcutaneous Use

Dispense enclosed Medication Guide to each patient.

Use one pen every week.

4 Single-dose prefilled pens

Lilly

NDC 0002-2460-80

Zepbound^®

(tirzepatide) injection

12.5 mg/0.5 mL

4 x 12.5 mg/0.5 mL prefilled pens

Rx Only

For Subcutaneous Use

Dispense enclosed Medication Guide to each patient.

Use one pen every week.

4 Single-dose prefilled pens

Lilly

ZEPBOUND lowers blood glucose. When initiating ZEPBOUND, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (e.g., sulfonylureas) to reduce the risk of hypoglycemia [see Warnings and Precautions (5.7)].

Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. Tirzepatide has not been studied in patients with non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.

Rx Only

NDC 0002-6612-11

Zepbound^®

(tirzepatide) injection

60 mg/2.4 mL

(25 mg/mL)

ATTENTION:

Contains 4 doses of 15 mg/0.6 mL

2.4 mL MULTI-DOSE VIAL

For Subcutaneous Use

Needles and Syringes are not included

Dispense enclosed Medication Guide to each patient.

Lilly

Rx Only

NDC 0002-6103-11

Zepbound^®

(tirzepatide) injection

20 mg/2.4 mL

(8.33 mg/mL)

ATTENTION:

Contains 4 doses of 5 mg/0.6 mL

2.4 mL MULTI-DOSE VIAL

For Subcutaneous Use

Needles and Syringes are not included

Dispense enclosed Medication Guide to each patient.

Lilly

Rx Only

NDC 0002-6304-11

Zepbound^®

(tirzepatide) injection

40 mg/2.4 mL

(16.7 mg/mL)

ATTENTION:

Contains 4 doses of 10 mg/0.6 mL

2.4 mL MULTI-DOSE VIAL

For Subcutaneous Use

Needles and Syringes are not included

Dispense enclosed Medication Guide to each patient.

Lilly

Rx Only

NDC 0002-6052-11

Zepbound^®

(tirzepatide) injection

10 mg/2.4 mL

(4.17 mg/mL)

ATTENTION:

Contains 4 doses of 2.5 mg/0.6 mL

2.4 mL MULTI-DOSE VIAL

For Subcutaneous Use

Needles and Syringes are not included

Dispense enclosed Medication Guide to each patient.

Lilly

Rx Only

NDC 0002-6210-11

Zepbound^®

(tirzepatide) injection

30 mg/2.4 mL

(12.5 mg/mL)

ATTENTION:

Contains 4 doses of 7.5 mg/0.6 mL

2.4 mL MULTI-DOSE VIAL

For Subcutaneous Use

Needles and Syringes are not included

Dispense enclosed Medication Guide to each patient.

Lilly

Rx Only

NDC 0002-6523-11

Zepbound^®

(tirzepatide) injection

50 mg/2.4 mL

(20.8 mg/mL)

ATTENTION:

Contains 4 doses of 12.5 mg/0.6 mL

2.4 mL MULTI-DOSE VIAL

For Subcutaneous Use

Needles and Syringes are not included

Dispense enclosed Medication Guide to each patient.

Lilly

Limitations of Use

ZEPBOUND contains tirzepatide. Coadministration with other tirzepatide-containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.

PACKAGE LABEL – ZEPBOUND KwikPen – 2.5 mg per dose (10 mg/2.4 mL [4.17 mg/mL])

NDC 0002-3566-11

Rx Only

Zepbound^®

KwikPen^®

(tirzepatide) injection

2.5 mg per dose

10 mg/2.4 mL (4.17 mg/mL)

1 Pen with 4 doses of 2.5 mg

TURN THE DOSE KNOB ALL THE WAY UNTIL YOU SEE A

For Single-Patient-Use Only

For Subcutaneous Use

Needles not included

Dispense enclosed Medication Guide to each patient.

Use ZEPBOUND KwikPen once weekly

Read the INSTRUCTIONS FOR USE. This product may have different steps than other products.

In the event of an overdosage, contact the Poison Help Line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. Appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms. A period of observation and treatment for these symptoms may be necessary, taking into account the half-life of tirzepatide of approximately 5 days.

ZEPBOUND (tirzepatide) injection, for subcutaneous use, contains tirzepatide, a GIP receptor and GLP-1 receptor agonist. Tirzepatide is based on the GIP sequence and contains aminoisobutyric acid (Aib) in positions 2 and 13, a C-terminal amide, and Lys residue at position 20 that is attached to 1,20-eicosanedioic acid via a linker. The molecular weight is 4813.53 Da and the empirical formula is C₂₂₅H₃₄₈N₄₈O₆₈.

Structural formula:

ZEPBOUND is a clear, colorless to slightly yellow, sterile solution for subcutaneous use. Each single-dose pen or single-dose vial contains a 0.5 mL solution of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide and the following excipients: sodium chloride (4.1 mg), sodium phosphate dibasic heptahydrate (0.7 mg), and water for injection. Each multi-dose vial or single-patient-use KwikPen contains 2.4 mL of solution, which provides 4 doses of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide per 0.6 mL. Each dose contains the following excipients: benzyl alcohol (5.4 mg), glycerin (4.8 mg), phenol (1.08 mg), sodium chloride (1.05 mg), sodium phosphate dibasic heptahydrate (0.8 mg), and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH. ZEPBOUND has a pH of 6.5 to 7.5.

Each single-patient-use KwikPen contains additional volume to allow for device priming.

ZEPBOUND lowers blood glucose and can cause hypoglycemia.

In a trial of patients with type 2 diabetes mellitus and BMI ≥27 kg/m² (Study 2), hypoglycemia (plasma glucose <54 mg/dL) was reported in 4.2% of ZEPBOUND-treated patients versus 1.3% of placebo-treated patients. In this trial, patients taking ZEPBOUND in combination with an insulin secretagogue (e.g., sulfonylurea) had increased risk of hypoglycemia (10.3%) compared to ZEPBOUND-treated patients not taking a sulfonylurea (2.1%). There is also increased risk of hypoglycemia in patients treated with tirzepatide in combination with insulin [see Drug Interactions (7.1)].

Hypoglycemia has also been associated with ZEPBOUND and GLP-1 receptor agonists in adults without type 2 diabetes mellitus [see Adverse Reactions (6.1)].

Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. In patients with diabetes mellitus, monitor blood glucose prior to starting ZEPBOUND and during ZEPBOUND treatment. The risk of hypoglycemia may be lowered by a reduction in the dose of insulin or sulfonylurea (or other concomitantly administered insulin secretagogue).

ZEPBOUND (tirzepatide) is a clear, colorless to slightly yellow solution available in cartons containing 4 pre-filled single-dose pens, 1 single-dose vial, 4 single-dose vials, 1 multi-dose vial, or 1 single-patient-use KwikPen as follows:

The safety and effectiveness of ZEPBOUND have not been established in pediatric patients.

In a pool of two fixed dose ZEPBOUND clinical studies for weight reduction (Study 1 and Study 2), 226 (9%) ZEPBOUND-treated patients were 65 years of age or older, and 13 (0.5%) ZEPBOUND-treated patients were 75 years of age or older at baseline.

No overall differences in safety or effectiveness of ZEPBOUND have been observed between patients 65 years of age and older and younger adult patients.

ZEPBOUND clinical studies in OSA (Study 5 and Study 6) did not include sufficient numbers of patients age 65 years or older to determine whether they respond differently from younger adult patients. Other reported clinical experience with tirzepatide has not identified differences in responses between the elderly and younger patients.

The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies.

The incidence of anti-drug antibodies (ADA) to ZEPBOUND was evaluated in adult patients with overweight or obesity or with OSA and obesity in clinical studies lasting 52 weeks or longer. Anti-tirzepatide antibodies were detected in 64.5% (1591/2467) of ZEPBOUND-treated patients in weight reduction clinical studies 1 and 2, and 60.6% (137/226) of ZEPBOUND-treated patients in OSA clinical studies [see Clinical Studies (14)].

Of the ZEPBOUND-treated patients in weight reduction clinical studies 40% and 16.5% of patients developed antibodies that were cross-reactive to native GIP or native GLP-1, respectively.

Of the ZEPBOUND-treated patients in OSA clinical studies, 37.2% and 19.5% of patients developed antibodies that were cross reactive to native GIP and native GLP-1, respectively.

Neutralizing antibodies against tirzepatide activity on the GIP or GLP-1 receptors and against native GIP or GLP-1 were detected in 2.8% and 2.7% and 0.8% and 0.1% respectively, of ZEPBOUND-treated patients in weight reduction clinical studies.

No ZEPBOUND-treated patients in OSA studies developed neutralizing antibodies against tirzepatide activity on the GIP or GLP-1 receptors or against native GIP or native GLP-1.

No clinically significant effect of anti-tirzepatide antibodies on pharmacokinetics or effectiveness of ZEPBOUND has been identified. More ZEPBOUND-treated patients who developed anti-tirzepatide antibodies experienced hypersensitivity reactions or injection site reactions than those who did not develop these antibodies [see Adverse Reactions (6.1)].

ZEPBOUND is contraindicated in patients with:

• A personal or family history of MTC or in patients with MEN 2 [see Warnings and Precautions (5.1)].
• Known serious hypersensitivity to tirzepatide or any of the excipients in ZEPBOUND. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with tirzepatide [see Warnings and Precautions (5.6) and Adverse Reactions (6.2)].

The following serious adverse reactions are described below or elsewhere in the prescribing information:

• Risk of Thyroid C-cell Tumors [see Warnings and Precautions (5.1)]
• Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.2)]
• Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions (5.3)]
• Acute Gallbladder Disease [see Warnings and Precautions (5.4)]
• Acute Pancreatitis [see Warnings and Precautions (5.5)]
• Hypersensitivity Reactions [see Warnings and Precautions (5.6)]
• Hypoglycemia [see Warnings and Precautions (5.7)]
• Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus [see Warnings and Precautions (5.8)]
• Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions (5.9)]

ZEPBOUND delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. (7.2)

ZEPBOUND delays gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with ZEPBOUND.

Monitor patients on oral medications dependent on threshold concentrations for efficacy and those with a narrow therapeutic index (e.g., warfarin) when concomitantly administered with ZEPBOUND.

Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation with ZEPBOUND and for 4 weeks after each dose escalation. Hormonal contraceptives that are not administered orally should not be affected [see Use in Specific Populations (8.3) and Clinical Pharmacology (12.2, 12.3)].

No dosage adjustment of ZEPBOUND is recommended for patients with renal impairment. In subjects with renal impairment including end-stage renal disease (ESRD), no change in tirzepatide pharmacokinetics (PK) was observed [see Clinical Pharmacology (12.3)]. Monitor renal function in patients reporting adverse reactions to ZEPBOUND that could lead to volume depletion [see Warnings and Precautions (5.3)].

Tirzepatide lowers body weight with greater fat mass loss than lean mass loss.

Tirzepatide decreases calorie intake. The effects are likely mediated by affecting appetite.

Tirzepatide stimulates insulin secretion in a glucose-dependent manner and reduces glucagon secretion. Tirzepatide increases insulin sensitivity, as demonstrated in a hyperinsulinemic euglycemic clamp study in patients with type 2 diabetes mellitus after 28 weeks of treatment. These effects can lead to a reduction of blood glucose.

Tirzepatide delays gastric emptying. The delay is largest after the first dose and this effect diminishes over time.

The pharmacokinetics of tirzepatide is similar between healthy subjects, patients with overweight or obesity, and patients with OSA and obesity. Steady-state plasma tirzepatide concentrations were achieved following 4 weeks of once weekly administration. Tirzepatide exposure increases in a dose-proportional manner.

Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, or ZEPBOUND [see Adverse Reactions (6)].

After initiation of ZEPBOUND, observe patients carefully for signs and symptoms of acute pancreatitis which may include persistent or severe abdominal pain (sometimes radiating to the back) and which may or may not be accompanied by nausea or vomiting. If pancreatitis is suspected, discontinue ZEPBOUND and initiate appropriate management.

No dosage adjustment of ZEPBOUND is recommended for patients with hepatic impairment. In a clinical pharmacology study in subjects with varying degrees of hepatic impairment, no change in tirzepatide PK was observed [see Clinical Pharmacology (12.3)].

ZEPBOUND^® is indicated in combination with a reduced-calorie diet and increased physical activity:

• to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.
• to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity.

Tirzepatide is a GIP receptor and GLP-1 receptor agonist. It contains a C20 fatty diacid that enables albumin binding and prolongs the half-life. Tirzepatide selectively binds to and activates both the GIP and GLP-1 receptors, the targets for native GIP and GLP-1.

GLP-1 is a physiological regulator of appetite and caloric intake. Nonclinical studies suggest the addition of GIP may further contribute to the regulation of food intake.

Both GIP receptors and GLP-1 receptors are found in areas of the brain involved in appetite regulation. Animal studies show that tirzepatide distributes to and activates neurons in brain regions involved in regulation of appetite and food intake.

ZEP-0008-MG-20260225

• Do not freeze ZEPBOUND. Do not use ZEPBOUND if frozen.
• Protect ZEPBOUND from heat and light.
• Store ZEPBOUND in the original carton to protect from light.

ZEPBOUND Single-dose Pen and Single-dose Vial

• Store ZEPBOUND single-dose pen and single-dose vial in a refrigerator at 2°C to 8°C (36°F to 46°F).
• If needed, each single-dose pen or single-dose vial can be stored unrefrigerated at temperatures not to exceed 30°C (86°F) for up to 21 days. If single-dose pen or single-dose vial is stored at room temperature, it should not be returned to the refrigerator.
• Discard single-dose pen and single-dose vial if not used within 21 days after removing from the refrigerator.

ZEPBOUND Multi-dose Vial or Single-Patient-Use KwikPen

Unopened vial or single-patient-use KwikPen:

• Store unopened multi-dose vial or single-patient-use KwikPen in the refrigerator at 2°C to 8°C (36°F to 46°F). The unopened multi-dose vial or single-patient-use KwikPen can be used until the expiration date on the label if kept in the refrigerator.
• If stored at room temperature [up to 30°C (86°F)], throw away unopened multi-dose vial or single-patient-use KwikPen after 30 days.

After vial or single-patient-use KwikPen has been opened:

• Store opened (in-use) multi-dose vial or single-patient-use KwikPen in the original carton in the refrigerator at 2°C to 8°C (36°F to 46°F) or at room temperature [up to 30°C (86°F)].
• Throw away opened multi-dose vial or single-patient-use KwikPen after a total of 30 days at room temperature, 30 days after first use, or after taking 4 weekly doses, even if there is medicine left in it.

• Severe Gastrointestinal Adverse Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. ZEPBOUND is not recommended in patients with severe gastroparesis. (5.2)
• Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. (5.3)
• Acute Gallbladder Disease: Has been reported in clinical trials. If cholecystitis is suspected, gallbladder studies and clinical follow-up are indicated. (5.4)
• Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, or ZEPBOUND. Discontinue if pancreatitis is suspected. (5.5)
• Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported postmarketing with tirzepatide. If suspected, advise patients to promptly seek medical attention and discontinue ZEPBOUND. (5.6)
• Hypoglycemia: Concomitant use with insulin or an insulin secretagogue may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing dose of insulin or insulin secretagogue may be necessary. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. (5.7)
• Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus: Has not been studied in patients with non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema. Monitor patients with a history of diabetic retinopathy for progression. (5.8)
• Pulmonary Aspiration During General Anesthesia or Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures. (5.9)
• Never share a ZEPBOUND KwikPen between patients, even if the pen needle is changed. (5.10)

Recommended Dose Escalation Schedule

• The recommended starting dosage is 2.5 mg injected subcutaneously once weekly for 4 weeks. Increase the dosage in 2.5 mg increments after at least 4 weeks until recommended maintenance dosage is achieved. (2.1)
• Consider treatment response and tolerability when selecting the maintenance dosage. (2.1)

Recommended Maintenance and Maximum Dosage

• Weight Reduction and Long-Term Maintenance: 5 mg, 10 mg, or 15 mg injected subcutaneously once weekly. (2.2)
• Obstructive Sleep Apnea: 10 mg or 15 mg injected subcutaneously once weekly. (2.2)

Maximum Recommended Dosage: 15 mg injected subcutaneously once weekly. (2.2)

Administration Instructions

Refer to the Full Prescribing Information for additional important administration instructions about ZEPBOUND presentations. (2.4)

Injection: Clear, colorless to slightly yellow solution in pre-filled single-dose pens, single-dose vials, multi-dose vials, or single-patient-use KwikPens, each available in the following strengths. The multi-dose vials and single-patient-use KwikPen each contain 4 doses:

The following adverse reactions have been reported during post-approval use of tirzepatide, the active ingredient in ZEPBOUND. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure.

Gastrointestinal: acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death, ileus, intestinal obstruction, severe constipation including fecal impaction

Hypersensitivity: anaphylaxis, angioedema

Pulmonary: Pulmonary aspiration has occurred in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation.

Renal: acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis

Treatment with ZEPBOUND and GLP-1 receptor agonists is associated with an increased occurrence of acute gallbladder disease.

In a pool of two ZEPBOUND clinical trials for weight reduction (Studies 1 and 2), cholelithiasis was reported in 1.1% of ZEPBOUND-treated patients and 1% of placebo-treated patients, cholecystitis was reported in 0.7% of ZEPBOUND-treated patients and 0.2% of placebo-treated patients, and cholecystectomy was reported in 0.2% of ZEPBOUND-treated patients and no placebo-treated patients. Acute gallbladder events were associated with weight reduction. Similar rates of cholelithiasis were reported in ZEPBOUND clinical trials for weight reduction and in ZEPBOUND trials for OSA. If cholecystitis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated.

• Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue ZEPBOUND. (8.1)
• Females of Reproductive Potential: Advise females using oral contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation. (8.3)

There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) in patients treated with tirzepatide. In a pool of two ZEPBOUND clinical studies for weight reduction (Studies 1 and 2), 0.1% of ZEPBOUND-treated patients had severe hypersensitivity reactions compared to no placebo-treated patients. Similar rates of severe hypersensitivity reactions were observed in ZEPBOUND clinical trials for weight reduction and in ZEPBOUND trials for OSA. If hypersensitivity reactions occur, advise patients to promptly seek medical attention and discontinue use of ZEPBOUND. Do not use in patients with a previous serious hypersensitivity reaction to tirzepatide or any of the excipients in ZEPBOUND [see Contraindications (4) and Adverse Reactions (6.2)].

Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with GLP-1 receptor agonists. Use caution in patients with a history of angioedema or anaphylaxis with a GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to these reactions with ZEPBOUND.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

In rats, tirzepatide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) in a 2-year study at clinically relevant plasma exposures [see Nonclinical Toxicology (13.1)]. It is unknown whether ZEPBOUND causes thyroid C-cell tumors, including MTC, in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined.

ZEPBOUND is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of ZEPBOUND and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).

Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with ZEPBOUND. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.

Important information you need to know before injecting ZEPBOUND

Read this Instructions for Use and the Medication Guide before using your ZEPBOUND pen and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Talk to your healthcare provider about how to inject ZEPBOUND the right way.

• ZEPBOUND is a single-dose prefilled pen.
• ZEPBOUND is used 1 time each week.
• Inject under the skin (subcutaneously) only.
• You or another person can inject into your stomach (abdomen) or thigh.
• Another person can inject into the back of your upper arm.

Guide to parts

Preparing to inject ZEPBOUND

Disposing of your used pen

• Put your used pen in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) pens in your household trash.
• If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
  • -
    made of a heavy-duty plastic,
  • -
    can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • -
    upright and stable during use,
  • -
    leak-resistant, and
  • -
    properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
• Do not recycle your used sharps disposal container.

Storage and handling

• Store your pen in the refrigerator between 36°F to 46°F (2°C to 8°C).
• You may store your pen at room temperature up to 86°F (30°C) for up to 21 days. If you store the pen at room temperature, do not return the pen to the refrigerator.
• Discard the pen if not used within 21 days after removing from the refrigerator.
• Do not freeze your pen. If the pen has been frozen, throw the pen away and use a new pen.
• Store your pen in the original carton to protect your pen from light.
• The pen has glass parts. Handle it carefully. If you drop the pen on a hard surface, do not use it. Use a new pen for your injection.
• Keep your ZEPBOUND pen and all medicines out of the reach of children.

Commonly asked questions

What if I see air bubbles in my pen?

Air bubbles are normal.

What if my pen is not at room temperature?

It is not necessary to warm the pen to room temperature.

What if I unlock the pen and press the purple injection button before pulling off the gray base cap?

Do not remove the gray base cap. Throw away the pen and get a new pen.

What if there is a drop of liquid on the tip of the needle when I remove the gray base cap?

A drop of liquid on the tip of the needle is normal. Do not touch the needle.

Do I need to hold the injection button down until the injection is complete?

This is not necessary, but it may help you keep the pen steady against your skin.

I heard more than 2 clicks during my injection—2 loud clicks and 1 soft one. Did I get my complete injection?

Some people may hear a soft click right before the second loud click. That is the normal operation of the pen. Do not remove the pen from your skin until you hear the second loud click.

I am not sure if my pen worked the right way.

What if there is a drop of liquid or blood on my skin after my injection?

This is normal. Press a cotton ball or gauze over the injection site. Do not rub the injection site.

Other information

• If you have vision problems, do not use your pen without help from a person trained to use the ZEPBOUND pen.

Where to learn more

• If you have questions or problems with your ZEPBOUND pen, contact Lilly at 1-800-Lilly-Rx (1-800-545-5979) or call your healthcare provider.
• For more information about the ZEPBOUND pen, visit our website at www.zepbound.com.

Marketed by:

Lilly USA, LLC

Indianapolis, IN 46285, USA

ZEPBOUND is a trademark of Eli Lilly and Company.

Copyright © 2023, Eli Lilly and Company. All rights reserved.

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised: November 2023

ZEP-0002-PEN-IFU-20231109

Important information you need to know before injecting ZEPBOUND

Read this Instructions for Use before you start taking ZEPBOUND and each time you get a new vial. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Do not share your needles or syringes with other people. You may give other people a serious infection or get a serious infection from them.

Talk to your healthcare provider about how to inject ZEPBOUND the right way.

• ZEPBOUND is a single-dose vial.
• ZEPBOUND is used 1 time each week.
• Inject under the skin (subcutaneously) only.
• You or another person may inject into your stomach (abdomen) or thigh.
• Another person can inject into the back of your upper arm.

Gather supplies needed to give your injection

• 1 single-dose ZEPBOUND vial
• 1 syringe and 1 needle, supplied separately (for example, use a 1 mL syringe and needle as recommended by your healthcare provider)
• 1 alcohol swab
• gauze
• 1 sharps container for throwing away used needles and syringes. See “Disposing of used needles and syringes” at the end of these instructions.

Note: The needle and syringe are not included. The needle and syringe recommended by your healthcare provider may look different than the needle and syringe in this Instructions for Use.

Preparing to inject ZEPBOUND

Remove the vial from the refrigerator.

Check the vial label to make sure you have the right medicine and dose, and that it has not expired.

Make sure the medicine:

Always use a new syringe and needle for each injection to prevent infections and blocked needles. Do not reuse or share your syringes or needles with other people. You may give other people a serious infection or get a serious infection from them.

Wash your hands with soap and water.

Injecting ZEPBOUND

• Inject exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you should pinch the skin before injecting.
• Change (rotate) your injection site within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
• Do not inject where the skin has pits, is thickened, or has lumps.
• Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
• Do not mix ZEPBOUND with any other medicine.
• Do not inject ZEPBOUND in the same injection site used for other medicines.

Disposing of used needles and syringes

• Put your used needle and syringe in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.
• If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
  • -
    made of a heavy-duty plastic,
  • -
    can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • -
    upright and stable during use,
  • -
    leak-resistant, and
  • -
    properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at:
  
  http://www.fda.gov/safesharpsdisposal.
• Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

Storing ZEPBOUND

• Store all unopened vials in the refrigerator at 36°F to 46°F (2°C to 8°C).
• You may store the unopened vial at room temperature up to 86°F (30°C) for up to 21 days.
• Do not freeze. Do not use if ZEPBOUND has been frozen.
• Store the vial in the original carton to protect from light.
• Throw away all opened vials after use, even if there is medicine left in the vial.

Keep ZEPBOUND vials, syringes, needles, and all medicines out of the reach of children.

If you have any questions or problems with your ZEPBOUND, contact Lilly at 1-800-Lilly-Rx (1-800-545-5979) or call your healthcare provider for help.

Marketed by:

Lilly USA, LLC

Indianapolis, IN 46285, USA

ZEPBOUND is a registered trademark of Eli Lilly and Company.

Copyright © 2024, Eli Lilly and Company. All rights reserved.

ZEP-0001-VL-IFU-20240328

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Issued: March 2024

• In rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether ZEPBOUND causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions (5.1) and Nonclinical Toxicology (13.1)].
• ZEPBOUND is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications (4)] . Counsel patients regarding the potential risk for MTC with the use of ZEPBOUND and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with ZEPBOUND [see Contraindications (4) and Warnings and Precautions (5.1)].

INSTRUCTIONS FOR USE

ZEPBOUND ^® [ZEHP-bownd] KwikPen ^® [KWIHK pehn]

(tirzepatide)

injection, for subcutaneous use

multi-dose single-patient-use prefilled pen

Each pen contains 4 fixed doses, one dose taken weekly.

This Instructions for Use contains information on how to inject ZEPBOUND.

Read this INSTRUCTIONS FOR USE before you start injecting ZEPBOUND KwikPen (Pen) and each time you get another new Pen. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

• ZEPBOUND KwikPen is a disposable multi-dose single-patient-use prefilled pen. The Pen contains 4 fixed doses, one dose taken weekly. Inject in a single weekly injection, under the skin (subcutaneously).

• For your weekly dose, you need to turn the dose knob all the way until it stops AND the

  icon is in dose window.

• After 4 doses, throw away (discard) the Pen, including the unused medicine. The Pen will prevent you from dialing a full dose after you have given yourself 4 weekly doses. Do not inject the leftover medicine. Do not transfer ZEPBOUND from your Pen into a syringe.
• Do not share your ZEPBOUND Pen with other people, even if the pen needle has been changed. You may give other people a serious infection or get a serious infection from them.
• People who are blind or have vision problems should not use the Pen without help from a person trained to use the Pen.

Parts of the ZEPBOUND Pen

Unused Pens:

• Store unused Pens in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Unused Pens may be used until the expiration date (EXP) printed on the label if the Pen has been kept in the refrigerator.
• Do not freeze your Pen. Throw away (discard) the Pen if it has been frozen.

Used Pens:

• You may store your used Pen at room temperature up to 86°F (30°C) after your injection.
• Keep away from heat and light.
• Keep your Pen and needles out of the sight and reach of children.
• Throw away the Pen 30 days after first use even though the Pen has medicine left in it.
• Throw away the Pen after receiving 4 weekly doses. Attempting to inject any leftover medicine could result in an incomplete dose even though the Pen still has medicine left in it.

• Put your used pen needles in an FDA-cleared sharps disposal container right away after use.
• Do not throw away (discard) loose pen needles in your household trash.
• Discard the used Pen in your household trash or FDA-cleared sharps disposal container after you have removed the needle.
• If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
  • –
    made of a heavy-duty plastic,
  • –
    can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • –
    upright and stable during use,
  • –
    leak-resistant, and
  • –
    properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away (discard) used needles. For more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
• Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

• If you cannot remove the Pen cap, gently twist the Pen cap back and forth, and then pull the Pen cap straight off.
• If the dose knob is hard to push:
  • –
    pushing the dose knob more slowly will make it easier to inject.
  • –
    your needle may be blocked. Put on a new pen needle and prime the Pen.
  • –
    you may have dust, food, or liquid inside the Pen. Throw the Pen away and get a new Pen.

• If the Pen prevents you from turning the dose knob until the

  is in the dose window:
  • –
    Throw away (discard) the Pen, including the unused medicine. There may not be enough medicine left in the pen to give a full dose. Do not attempt to inject the leftover medicine.

Additional Information:

If you have any questions or problems with ZEPBOUND KwikPen:

ZEPBOUND^® and KwikPen^® are registered trademarks of Eli Lilly and Company.

Marketed by:

Lilly USA, LLC

Indianapolis, IN 46285, USA

Copyright © 2026, Eli Lilly and Company. All rights reserved.

ZEPBOUND KwikPen meets the current dose accuracy and functional requirements of ISO 11608-1.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: January 2026

ZEPKP-0002-IFU-20260121

INSTRUCTIONS FOR USE

ZEPBOUND^® [ZEHP-bownd]

(tirzepatide)

injection, for subcutaneous use

Multi-dose vial

Each vial contains 4 doses, one dose taken weekly.

Important information you need to know before injecting ZEPBOUND

Read this Instructions for Use before you start taking ZEPBOUND and each time you get a new vial. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Do not share your needles or syringes with other people.

Talk to your healthcare provider about how to inject ZEPBOUND the right way.

• ZEPBOUND is a multi-dose vial. The vial contains 4 doses, one dose taken weekly.
• Inject 0.6 mL in a single weekly injection, under the skin (subcutaneously).
• You or another person may inject into your stomach (abdomen) or thigh.
• Another person can inject into the back of your upper arm.

Gather supplies needed to give your injection

• 1 multi-dose ZEPBOUND vial
• 1 syringe and 1 needle, supplied separately (for example, use a 1 mL syringe and needle as recommended by your healthcare provider)
• 1 alcohol swab
• gauze
• 1 sharps container for throwing away used needles and syringes. See “Disposing of used needles and syringes” at the end of these instructions.

Note: The needle and syringe are not included. The needle and syringe recommended by your healthcare provider may look different than the needle and syringe in this Instructions for Use.

Preparing to inject ZEPBOUND

Check the vial label to make sure you have the right medicine and dose, and that it has not expired.

Make sure the medicine:

Always use a new syringe and needle for each injection to prevent infections and blocked needles. Do not reuse or share your syringes or needles with other people. You may give other people a serious infection or get a serious infection from them.

Wash your hands with soap and water.

Injecting ZEPBOUND

• Inject exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you should pinch the skin before injecting.
• Change (rotate) your injection site within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
• Do not inject where the skin has pits, is thickened, or has lumps.
• Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
• Do not mix ZEPBOUND with any other medicine.
• Do not inject ZEPBOUND in the same injection site used for other medicines.

Disposing of used needles and syringes

• Put your used needle and syringe in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.
• If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
  • -
    made of a heavy-duty plastic,
  • -
    can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • -
    upright and stable during use,
  • -
    leak-resistant, and
  • -
    properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at:
  
  http://www.fda.gov/safesharpsdisposal.
• Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

Storing ZEPBOUND

• Do not freeze. Do not use if ZEPBOUND has been frozen.
• Store ZEPBOUND in original carton. Keep away from light.

Unopened vial:

• Store unopened vial in the refrigerator at 36°F to 46°F (2°C to 8°C). It can be used until the expiration date on the label if kept in the refrigerator.
• If stored at room temperature [up to 86°F (30°C)], throw away unopened vial after 30 days.

After vial has been opened:

• Store opened (in-use) vial in the original carton in the refrigerator at 36°F to 46°F (2°C to 8°C) or at room temperature [up to 86°F (30°C)]. Throw away opened vial after a total of 30 days at room temperature, 30 days after first use, or after taking 4 weekly doses, even if there is medicine left in it.

Keep ZEPBOUND vials, syringes, needles, and all medicines out of the reach of children.

If you have any questions or problems with your ZEPBOUND, contact Lilly at 1-800-Lilly-Rx (1-800-545-5979) or call your healthcare provider for help.

Marketed by:

Lilly USA, LLC

Indianapolis, IN 46285, USA

ZEPBOUND is a registered trademark of Eli Lilly and Company.

Copyright © 2026, Eli Lilly and Company. All rights reserved.

ZEP-0001-MDV-IFU-20260107

This Instructions for Use has been approved by the U.S. Food and Drug Administration .

Revised: January 2026

• The recommended starting dosage of ZEPBOUND for all indications is 2.5 mg injected subcutaneously once weekly for 4 weeks.
• The 2.5 mg dosage is for treatment initiation and is not approved as a maintenance dosage.
• Follow the dosage escalation below for all indications to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].
• After 4 weeks, increase the dosage to 5 mg injected subcutaneously once weekly. The dosage may be increased in 2.5 mg increments, after at least 4 weeks on the current dose [see Dosage and Administration (2.2)].
• Consider treatment response and tolerability when selecting the maintenance dosage. If patients do not tolerate a maintenance dosage, consider a lower maintenance dosage.

• If a dose is missed, instruct patients to administer ZEPBOUND as soon as possible within 4 days (96 hours) after the missed dose. If more than 4 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.
• The day of weekly administration can be changed, if necessary, as long as the time between the two doses is at least 3 days (72 hours).

• Inform patients and their caregiver(s) which ZEPBOUND presentation (e.g., vial, prefilled single-dose pen, single-patient-use KwikPen) they will receive and ensure they receive training appropriate for that specific presentation. If the prescribed ZEPBOUND presentation changes, ensure patients and caregivers receive appropriate training and instruct them to consult the Instructions for Use for the newly prescribed presentation.
• Prior to initiation, train patients and their caregiver(s) on proper injection technique for the prescribed ZEPBOUND presentation [see Instructions for Use]. After training, a patient may self-inject ZEPBOUND if the healthcare provider determines that it can be properly administered, except for the following:
  • ZEPBOUND KwikPen is not recommended for self-administration by those who are visually impaired.
• Instruct patients using ZEPBOUND vials to use a syringe appropriate for dose administration (e.g., a 1 mL syringe capable of measuring a 0.5 mL or 0.6 mL dose) and always use a new syringe and needle for each injection.
• Inspect ZEPBOUND visually before use. It should appear clear and colorless to slightly yellow. Do not use ZEPBOUND if particulate matter or discoloration is seen.
• Administer ZEPBOUND in combination with a reduced-calorie diet and increased physical activity.
• Administer ZEPBOUND once weekly at any time of day, with or without meals.
• Inject ZEPBOUND subcutaneously in the abdomen, thigh, or another person should inject in the back of the upper arm.
• Rotate injection sites with each dose.

Use of ZEPBOUND has been associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions (6)]. In a pool of two ZEPBOUND clinical trials for weight reduction (Studies 1 and 2), severe gastrointestinal adverse reactions were reported more frequently among patients receiving ZEPBOUND (5 mg 1.7%, 10 mg 2.5%, 15 mg 3.1%) than placebo (1%). Similar rates of severe gastrointestinal adverse reactions were observed in ZEPBOUND clinical trials for weight reduction and in ZEPBOUND clinical trials for OSA. Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists.

ZEPBOUND is not recommended in patients with severe gastroparesis.

There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with GLP-1 receptor agonists, or ZEPBOUND [see Adverse Reactions (6.2)]. The majority of the reported events occurred in patients who experienced gastrointestinal adverse reactions leading to dehydration such as nausea, vomiting, or diarrhea [see Adverse Reactions (6.1)]. Monitor renal function in patients reporting adverse reactions to ZEPBOUND that could lead to volume depletion, especially during dosage initiation and escalation of ZEPBOUND.

A 2-year carcinogenicity study was conducted with tirzepatide in male and female rats at doses of 0.15, 0.50, and 1.5 mg/kg (0.1-, 0.4-, and 1-fold the MRHD of 15 mg once weekly based on AUC) administered by subcutaneous injection twice weekly. A statistically significant increase in thyroid C-cell adenomas was observed in male rats (≥0.5 mg/kg) and female rats (≥0.15 mg/kg), and a statistically significant increase in thyroid C-cell adenomas and carcinomas combined was observed in male and female rats at all doses examined. In a 6-month carcinogenicity study in rasH2 transgenic mice, tirzepatide at doses of 1, 3, and 10 mg/kg administered by subcutaneous injection twice weekly was not tumorigenic.

Tirzepatide was not genotoxic in a rat bone marrow micronucleus assay.

In fertility and early embryonic development studies, male and female rats were administered twice weekly subcutaneous doses of 0.5, 1.5, or 3 mg/kg (0.3-, 1-, and 2-fold and 0.3-, 0.9-, and 2-fold, respectively, the MRHD of 15 mg once weekly based on AUC). No effects of tirzepatide were observed on sperm morphology, mating, fertility, and conception. In female rats, an increase in the number of females with prolonged diestrus and a decrease in the mean number of corpora lutea resulting in a decrease in the mean number of implantation sites and viable embryos was observed at all dose levels. These effects were considered secondary to the pharmacological effects of tirzepatide on food consumption and body weight.

NDC 0002-0243-04

Zepbound^®

(tirzepatide) injection

5 mg/0.5 mL

Rx Only

For Subcutaneous Use

Needles and Syringes are not included

Dispense enclosed Medication Guide to each patient.

Use one vial every week.

4 Single-dose vials

Discard unused portion

Lilly

NDC 0002-1340-04

Zepbound^®

(tirzepatide) injection

10 mg/0.5 mL

Rx Only

For Subcutaneous Use

Needles and Syringes are not included

Dispense enclosed Medication Guide to each patient.

Use one vial every week.

4 Single-dose vials

Discard unused portion

Lilly

NDC 0002-2002-04

Zepbound^®

(tirzepatide) injection

15 mg/0.5 mL

Rx Only

For Subcutaneous Use

Needles and Syringes are not included

Dispense enclosed Medication Guide to each patient.

Use one vial every week.

4 Single-dose vials

Discard unused portion

Lilly

NDC 0002-0152-04

Zepbound^®

(tirzepatide) injection

2.5 mg/0.5 mL

Rx Only

For Subcutaneous Use

Needles and Syringes are not included

Dispense enclosed Medication Guide to each patient.

Use one vial every week.

4 Single-dose vials

Discard unused portion

Lilly

NDC 0002-1214-04

Zepbound^®

(tirzepatide) injection

7.5 mg/0.5 mL

Rx Only

For Subcutaneous Use

Needles and Syringes are not included

Dispense enclosed Medication Guide to each patient.

Use one vial every week.

4 Single-dose vials

Discard unused portion

Lilly

NDC 0002-1423-04

Zepbound^®

(tirzepatide) injection

12.5 mg/0.5 mL

Rx Only

For Subcutaneous Use

Needles and Syringes are not included

Dispense enclosed Medication Guide to each patient.

Use one vial every week.

4 Single-dose vials

Discard unused portion

Lilly

ZEPBOUND delays gastric emptying [see Clinical Pharmacology (12.2)]. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations.

Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking ZEPBOUND, including whether modifying preoperative fasting recommendations or temporarily discontinuing ZEPBOUND could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking ZEPBOUND.

NDC 0002-2495-80

Zepbound^®

(tirzepatide) injection

5 mg/0.5 mL

4 x 5 mg/0.5 mL prefilled pens

Rx Only

For Subcutaneous Use

Dispense enclosed Medication Guide to each patient.

Use one pen every week.

4 Single-dose prefilled pens

Lilly

NDC 0002-2471-80

Zepbound^®

(tirzepatide) injection

10 mg/0.5 mL

4 x 10 mg/0.5 mL prefilled pens

Rx Only

For Subcutaneous Use

Dispense enclosed Medication Guide to each patient.

Use one pen every week.

4 Single-dose prefilled pens

Lilly

NDC 0002-2457-80

Zepbound^®

(tirzepatide) injection

15 mg/0.5 mL

4 x 15 mg/0.5 mL prefilled pens

Rx Only

For Subcutaneous Use

Dispense enclosed Medication Guide to each patient.

Use one pen every week.

4 Single-dose prefilled pens

Lilly

NDC 0002-2506-80

Zepbound^®

(tirzepatide) injection

2.5 mg/0.5 mL

4 x 2.5 mg/0.5 mL prefilled pens

Rx Only

For Subcutaneous Use

Dispense enclosed Medication Guide to each patient.

Use one pen every week.

4 Single-dose prefilled pens

Lilly

NDC 0002-2484-80

Zepbound^®

(tirzepatide) injection

7.5 mg/0.5 mL

4 x 7.5 mg/0.5 mL prefilled pens

Rx Only

For Subcutaneous Use

Dispense enclosed Medication Guide to each patient.

Use one pen every week.

4 Single-dose prefilled pens

Lilly

NDC 0002-2460-80

Zepbound^®

(tirzepatide) injection

12.5 mg/0.5 mL

4 x 12.5 mg/0.5 mL prefilled pens

Rx Only

For Subcutaneous Use

Dispense enclosed Medication Guide to each patient.

Use one pen every week.

4 Single-dose prefilled pens

Lilly

ZEPBOUND lowers blood glucose. When initiating ZEPBOUND, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (e.g., sulfonylureas) to reduce the risk of hypoglycemia [see Warnings and Precautions (5.7)].

Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. Tirzepatide has not been studied in patients with non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.

Rx Only

NDC 0002-6612-11

Zepbound^®

(tirzepatide) injection

60 mg/2.4 mL

(25 mg/mL)

ATTENTION:

Contains 4 doses of 15 mg/0.6 mL

2.4 mL MULTI-DOSE VIAL

For Subcutaneous Use

Needles and Syringes are not included

Dispense enclosed Medication Guide to each patient.

Lilly

Rx Only

NDC 0002-6103-11

Zepbound^®

(tirzepatide) injection

20 mg/2.4 mL

(8.33 mg/mL)

ATTENTION:

Contains 4 doses of 5 mg/0.6 mL

2.4 mL MULTI-DOSE VIAL

For Subcutaneous Use

Needles and Syringes are not included

Dispense enclosed Medication Guide to each patient.

Lilly

Rx Only

NDC 0002-6304-11

Zepbound^®

(tirzepatide) injection

40 mg/2.4 mL

(16.7 mg/mL)

ATTENTION:

Contains 4 doses of 10 mg/0.6 mL

2.4 mL MULTI-DOSE VIAL

For Subcutaneous Use

Needles and Syringes are not included

Dispense enclosed Medication Guide to each patient.

Lilly

Rx Only

NDC 0002-6052-11

Zepbound^®

(tirzepatide) injection

10 mg/2.4 mL

(4.17 mg/mL)

ATTENTION:

Contains 4 doses of 2.5 mg/0.6 mL

2.4 mL MULTI-DOSE VIAL

For Subcutaneous Use

Needles and Syringes are not included

Dispense enclosed Medication Guide to each patient.

Lilly

Rx Only

NDC 0002-6210-11

Zepbound^®

(tirzepatide) injection

30 mg/2.4 mL

(12.5 mg/mL)

ATTENTION:

Contains 4 doses of 7.5 mg/0.6 mL

2.4 mL MULTI-DOSE VIAL

For Subcutaneous Use

Needles and Syringes are not included

Dispense enclosed Medication Guide to each patient.

Lilly

Rx Only

NDC 0002-6523-11

Zepbound^®

(tirzepatide) injection

50 mg/2.4 mL

(20.8 mg/mL)

ATTENTION:

Contains 4 doses of 12.5 mg/0.6 mL

2.4 mL MULTI-DOSE VIAL

For Subcutaneous Use

Needles and Syringes are not included

Dispense enclosed Medication Guide to each patient.

Lilly