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

Induction Dosage

OMV-0005-MG-20251027

Storage and Handling

• Store refrigerated at 2°C to 8°C (36°F to 46°F).
• Do not freeze. Do not use OMVOH if it has been frozen.
• Do not shake.
• Keep OMVOH in the original carton to protect from light until the time of use.
• OMVOH is sterile and preservative-free. Discard any unused portion.
• If needed, the prefilled pen or prefilled syringe may be stored at room temperature up to 30°C (86°F) for up to 2 weeks in the original carton to protect from light. Once OMVOH has been stored at room temperature, do not return to the refrigerator. If these conditions are exceeded, OMVOH must be discarded.
• The vial, prefilled pen, and prefilled syringe are not made with dry natural rubber latex.

PACKAGE LABEL – Omvoh 300 mg Vial Cartons

There are two formulations for this product

NDC 0002-7575-01

15 mL

omvoh^TM

(mirikizumab-mrkz)

injection

300 mg/15 mL

(20 mg/mL)

For Intravenous Infusion After Dilution

Single-Dose Vial - Discard Unused Portion

Dispense enclosed Medication Guide to each patient.

Rx only

omvoh.com

Lilly

Classic Formulation contains the following inactive ingredients:anhydrous citric acid, polysorbate 80, sodium chloride, sodium citrate, and Water for Injection.

Alternate Formulation contains the following inactive ingredients: anhydrous citric acid, histidine, L-histidine hydrochloride monohydrate, mannitol, polysorbate 80, sodium chloride, sodium citrate, and Water for Injection.

Mirikizumab-mrkz is a humanized immunoglobulin G4 (IgG4) variant monoclonal antibody that is directed against the p19 subunit of IL-23 and does not bind IL-12. Mirikizumab-mrkz is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology and it is composed of two identical light chain polypeptides and two identical heavy chain polypeptides with an overall molecular weight of approximately 147 kDa.

OMVOH may increase the risk of infection [see Adverse Reactions (6.1)].

Do not initiate treatment with OMVOH in patients with a clinically important active infection until the infection resolves or is adequately treated.

In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing OMVOH. Instruct patients to seek medical advice if signs or symptoms of clinically important acute or chronic infection occur. If a serious infection develops or an infection is not responding to standard therapy, monitor the patient closely and do not administer OMVOH until the infection resolves.

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with OMVOH.

Do not administer OMVOH to patients with active TB infection. Initiate treatment of latent TB prior to administering OMVOH. Consider anti-TB therapy prior to initiation of OMVOH in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after OMVOH treatment.

In clinical trials, subjects were excluded if they had evidence of active TB, a past history of active TB, or were diagnosed with latent TB at screening.

Avoid use of live vaccines in patients treated with OMVOH. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy with OMVOH, complete all age-appropriate vaccinations according to current immunization guidelines. No data are available on the response to live or non-live vaccines in patients treated with OMVOH.

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

Of the 795 OMVOH-treated subjects in the two ulcerative colitis clinical studies, 64 subjects (8%) were 65 years of age and older, while 10 subjects (1%) were 75 years of age and older. Of the 715 OMVOH-treated subjects in the Crohn's disease clinical study, 22 subjects (3%) were 65 years of age and older, while 6 subjects (1%) were 75 years of age and older). These clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger adult subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects. No clinically meaningful differences in the pharmacokinetics of mirikizumab-mrkz were observed in subjects 65 years of age and older compared to younger adult subjects [see Clinical Pharmacology (12.3)].

A case of drug-induced liver injury (alanine aminotransferase [ALT] 18x the upper limit of normal (ULN), aspartate aminotransferase [AST] 10x ULN, and total bilirubin 2.4x ULN) in conjunction with pruritus was reported in a clinical trial subject following a longer than recommended induction regimen. OMVOH was discontinued. Liver test abnormalities eventually returned to baseline.

Evaluate liver enzymes and bilirubin at baseline and for at least 24 weeks of treatment. Monitor thereafter according to routine patient management.

Consider other treatment options in patients with evidence of liver cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.

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, including those of mirikizumab-mrkz or of other mirikizumab products.

During the 52-week treatment period in studies UC-1 and UC-2, 23% (88/378) of OMVOH-treated subjects at the recommended dosage and evaluable for assessment, developed anti-mirikizumab-mrkz antibodies (referred to as anti-drug antibodies (ADA)). Of those who developed ADA, 33/88 (38%) developed titers ≥1:160. Of these 33 OMVOH-treated subjects, 10 had reduced serum trough concentrations of mirikizumab-mrkz compared to subjects who did not develop anti-mirikizumab-mrkz antibodies, and 5 of these 10 subjects did not achieve clinical response at Week 52. There is insufficient data to assess whether the observed ADA-associated pharmacokinetic changes reduced effectiveness. There is no identified clinically significant effect of ADA on the safety of OMVOH over the treatment duration of 52-weeks.

During the 52-week treatment period in study CD-1, 13% (79/622) of OMVOH-treated subjects at the recommended dosage and evaluable for assessment developed ADA. There is no identified clinically significant effect of ADA on the pharmacokinetics, effectiveness, or safety of OMVOH over the treatment duration of 52-weeks.

OMVOH is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients [see Warnings and Precautions (5.1)].

The following topics are also discussed in detail in the Warnings and Precautions section:

• Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
• Infections [see Warnings and Precautions (5.2)]
• Tuberculosis [see Warnings and Precautions (5.3)]
• Hepatotoxicity [see Warnings and Precautions (5.4)]

The safety and efficacy of OMVOH was evaluated in a randomized, double-blind, placebo-controlled study [CD-1 (NCT03926130)] in adult subjects with moderately to severely active Crohn's disease who had an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine, and methotrexate), and/or biologics (TNF blockers, integrin receptor antagonists).

In CD-1, the efficacy population consisted of 679 subjects who were randomized 3:1 at Week 0 to receive OMVOH 900 mg by intravenous infusion at Week 0, Week 4, and Week 8 followed by a dosage of 300 mg by subcutaneous injection at Week 12 and then every 4 weeks for 40 weeks, or placebo. Subjects had a mean age of 36 years (range 18 to 74 years); 42% were female; and 71% identified as White, 25% as Asian, <1% as American Indian or Alaska Native, 1% as Black or African American, and 2% as another racial group or did not report their racial group. Subjects were permitted to use stable doses of oral corticosteroids (prednisone ≤30 mg/day or equivalent, extended-release budesonide 9 mg/day), immunomodulators (6-mercatopurine, azathioprine, or methotrexate) and/or aminosalicylates. At baseline, 31% of subjects were receiving oral corticosteroids, 26% were receiving immunomodulators, and 44% were receiving aminosalicylates.

At baseline, 47% had a loss of response, inadequate response, or intolerance to one or more biologic therapy.

Disease activity at baseline was assessed by the Crohn's Disease Activity Index (CDAI) and the Simple Endoscopic Score for Crohn's disease (SES-CD). Moderately to severely active CD was defined by a CDAI of ≥220 and an SES-CD ≥7 (centrally read) for subjects with ileal-colonic disease or ≥4 for subjects with isolated ileal disease. At baseline, subjects had a median CDAI of 329 and SES-CD of 12.

The coprimary endpoints of clinical remission by CDAI and endoscopic response by SES-CD were assessed at Week 52. Secondary efficacy endpoints included endoscopic response at Week 12 and endoscopic remission and corticosteroid-free clinical remission at Week 52 (see Table 9).

In both study UC-1 (induction) and study UC-2 (maintenance), a positive relationship was observed between Mirikizumab-mrkz average concentration and rates of clinical remission and clinical response [see Clinical Studies (14.1)].

Mirikizumab exposure response relationships have not been fully characterized in subjects with Crohn's disease.

Mirikizumab-mrkz exhibited linear pharmacokinetics with dose-proportional increase in exposure over a dose range of 60 to 2400 mg given as an intravenous injection or over a dose range of 200 to 400 mg given as a subcutaneous injection, in healthy volunteers. There was no apparent accumulation of mirikizumab-mrkz concentrations in serum over time when administered as a subcutaneous injection every 4 weeks to subjects with ulcerative colitis or Crohn's disease. The estimated exposure parameters of mirikizumab-mrkz at steady state are summarized in Tables 5 for ulcerative colitis and 6 for Crohn's disease.

Increased concentrations of cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation associated with certain diseases including Crohn's disease may suppress the formation of CYP450 enzymes. Therapeutic proteins, including mirikizumab-mrkz, that decrease the concentrations of these pro-inflammatory cytokines may increase the formation of CYP450 enzymes resulting in decreased CYP450 substrate exposure. Upon initiation or discontinuation of OMVOH in patients treated with concomitant CYP450 substrates, monitor drug concentrations or other therapeutic parameters, and adjust the dosage of the CYP450 substrate as needed. See the prescribing information of specific CYP450 substrates.

OMVOH is indicated for the treatment of:

• moderately to severely active ulcerative colitis in adults.
• moderately to severely active Crohn's disease in adults.

The safety and efficacy of OMVOH was evaluated in two randomized, double-blind, placebo-controlled clinical studies, one induction study [UC-1 (NCT03518086)] and one maintenance study [UC-2 (NCT03524092)], in adult subjects with moderately to severely active ulcerative colitis who had inadequate response, loss of response, or failed to tolerate any of the following: corticosteroids, 6-mercaptopurine, azathioprine, biologic therapy (TNF blocker, vedolizumab), or tofacitinib. The 12-week intravenous induction study (UC-1) was followed by the 40-week subcutaneous randomized withdrawal maintenance study (UC-2).

Mirikizumab-mrkz is a humanized IgG4 monoclonal antibody that selectively binds to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor.

IL-23 is involved in mucosal inflammation and affects the differentiation, expansion, and survival of T cell subsets, and innate immune cell subsets, which represent sources of pro-inflammatory cytokines. Research in animal models has shown that pharmacologic inhibition of IL-23p19 can ameliorate intestinal inflammation.

Mirikizumab-mrkz inhibits the release of pro-inflammatory cytokines and chemokines.

• Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis and infusion-related reactions, have been reported. If a severe hypersensitivity reaction occurs, discontinue and initiate appropriate treatment. (5.1)
• Infections: OMVOH may increase the risk of infection. Do not initiate treatment with OMVOH in patients with a clinically important active infection until the infection resolves or is adequately treated. If a serious infection develops, do not administer OMVOH until the infection resolves. (5.2)
• Tuberculosis: Do not administer OMVOH to patients with active TB infection. Monitor patients receiving OMVOH for signs and symptoms of active TB during and after treatment. (5.3)
• Hepatotoxicity: Drug-induced liver injury has been reported. Monitor liver enzymes and bilirubin levels at baseline and for at least 24 weeks of treatment and thereafter according to routine patient management. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. (5.4)
• Immunizations: Avoid use of live vaccines. (5.5)

Prior to Treatment Initiation

• Evaluate patients for tuberculosis (TB) infection. (2.1, 5.3)
• Obtain liver enzymes and bilirubin levels. (2.1, 5.4)
• Complete all age-appropriate vaccinations according to current immunization guidelines. (2.1, 5.5)

Recommended Dosage for Ulcerative Colitis

• Induction Dosage: Week 0, Week 4, and Week 8: Infuse 300 mg intravenously over at least 30 minutes. (2.2)
• Maintenance Dosage: Week 12 and every 4 weeks thereafter: Inject 200 mg subcutaneously (given as either one injection of 200 mg or as two consecutive injections of 100 mg each). (2.2)

Recommended Dosage for Crohn's Disease

• Induction Dosage: Week 0, Week 4, and Week 8: Infuse 900 mg intravenously over at least 90 minutes. (2.3)
• Maintenance Dosage: Week 12 and every 4 weeks thereafter: Inject 300 mg subcutaneously (given as two consecutive injections of 100 mg and 200 mg in any order). (2.3)

Preparation and Administration Instructions

• See the full prescribing information for preparation, administration and storage information for intravenous infusion and subcutaneous injection. (2.2, 2.3, 2.4, 2.5)

OMVOH is a clear to opalescent, colorless to slightly yellow to slightly brown solution available as:

• Intravenous Infusion:
  
  Injection: 300 mg/15 mL (20 mg/mL) solution in a single-dose vial
• Subcutaneous Use:
  
  Injection: 100 mg/mL solution in a single-dose prefilled pen
  
  Injection: 100 mg/mL solution in a single-dose prefilled syringe
  
  Injection: 200 mg/2 mL solution in a single-dose prefilled pen
  
  Injection: 200 mg/2 mL (100 mg/mL) solution in a single-dose prefilled syringe

Serious hypersensitivity reactions, including anaphylaxis during intravenous infusion, have been reported with OMVOH administration. Infusion-related hypersensitivity reactions, including mucocutaneous erythema and pruritus, were reported during induction [see Adverse Reactions (6.1)]. If a severe hypersensitivity reaction occurs, discontinue OMVOH immediately and initiate appropriate treatment.

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

OMVOH (mirikizumab-mrkz) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow to slightly brown solution for intravenous infusion or subcutaneous injection.

OMVOH is supplied in indication specific packaging as:

Note to Pharmacist: The entire carton of 2 prefilled pen or 2 prefilled syringes are to be dispensed as a unit.

Each 100 mg/mL single-dose prefilled pen or prefilled syringe consists of a 1 mL glass syringe with a fixed 27-gauge ½ inch needle.

Each 200 mg/2 mL single-dose prefilled pen or 200 mg/2 mL (100 mg/mL) prefilled syringe consists of a 2 mL glass syringe with a fixed 27-gauge 8 mm needle.

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

Manufactured by:

Eli Lilly and Company

Indianapolis, IN 46285, USA

US License Number 1891

OMVOH™ is a trademark of Eli Lilly and Company.

Copyright © 2023, 2025, Eli Lilly and Company. All rights reserved.

Revised: October 2025

The OMVOH prefilled Pen meets the current dose accuracy and functional requirements of ISO 11608-1 and 11608-5.

OMV-0005-IFU-PEN-20251023

Throwing away (disposing of) OMVOH prefilled Pen

Manufactured by:

Eli Lilly and Company

Indianapolis, IN 46285, USA

US License Number 1891

OMVOH™ is a trademark of Eli Lilly and Company.

Copyright © 2025, Eli Lilly and Company. All rights reserved.

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

Approved: October 2025

The OMVOH prefilled Pen meets the current dose accuracy and functional requirements of ISO 11608-1 and 11608-5.

OMV-0001-200MG-PEN-IFU-20251023

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

Manufactured by:

Eli Lilly and Company

Indianapolis, IN 46285, USA

US License Number 1891

OMVOH^TM is a trademark of Eli Lilly and Company.

Copyright © 2024, 2025, Eli Lilly and Company. All rights reserved.

Revised: October 2025

OMV-0003-IFU-PFS-20251023

Manufactured by:

Eli Lilly and Company

Indianapolis, IN 46285, USA

US License Number 1891

OMVOH is a trademark of Eli Lilly and Company.

Copyright © 2025, Eli Lilly and Company. All rights reserved.

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

Approved: October 2025

OMV-0001-200MG-PFS-IFU-20251023

INSTRUCTIONS FOR USE

OMVOH ^TM (ahm-voh)

(mirikizumab-mrkz)

injection, for subcutaneous use

Prefilled Pens

One 200 mg/2 mL Prefilled Pen and one 100 mg/mL Prefilled Pen for a full dose of 300 mg

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

Before you use the OMVOH prefilled Pens, read and carefully follow all the step-by-step instructions.

Important information you need to know before injecting OMVOH

• Your healthcare provider should show you how to prepare and inject OMVOH using the prefilled Pens. Do not inject yourself or someone else until you have been shown how to inject OMVOH.
• Keep this Instructions for Use and read it as needed.
• Each OMVOH prefilled Pen is for one-time use only.
• The OMVOH prefilled Pen contains glass parts. Handle it carefully. If you drop it on a hard surface, do not use it. Use a new OMVOH prefilled Pen for your injection.
• Your healthcare provider can help you decide where on your body to inject your dose. Read the Choose and clean your injection sites section of these instructions to help you choose which area can work best for you.
• If you have vision or hearing problems, do not use OMVOH prefilled Pens without help from a caregiver.
• See Storing OMVOH Prefilled Pens for important storage information.

INSTRUCTIONS FOR USE

Before you use the OMVOH prefilled Pens, read and carefully follow all the step-by-step instructions.

2 Prefilled Pens = full 300 mg dose

After your first injection, choose a new injection site at least 2 inches (5 centimeters) away and clean it.

With your second prefilled Pen, repeat steps 1 to 3 right away after your first injection.

You must inject 2 prefilled Pens to complete your full 300 mg dose.

Parts of the OMVOH Prefilled Pens

Inject both prefilled Pens in any order for a full 300 mg dose.

The 200 mg/2 mL prefilled Pen is larger than the 100 mg/mL prefilled Pen.

Preparing to inject OMVOH

Gather supplies

Inspect the prefilled Pens and the medicine

Remove both prefilled Pens from the carton.

Make sure you have the right medicine.

The medicine inside should be clear. It may be colorless to slightly yellow to slightly brown.

Wait 45 minutes

Do not warm up the prefilled Pens with a microwave, hot water, or direct sunlight.

With the gray base cap on, allow the prefilled Pens to warm up to room temperature for 45 minutes before injecting.

Choose and clean your injection sites

Your healthcare provider can help you choose the injection sites that are best for you. Clean the injection sites with an alcohol wipe and let them dry.

Injecting OMVOH

1. Uncap the first prefilled Pen (the prefilled Pens may be used in any order)

2. Place and unlock

3. Press and hold for 15 seconds

4. Inject the second prefilled Pen

Choose a new injection site at least 2 inches away and clean it.

With your second prefilled Pen, repeat steps 1 to 3 right away after your first injection.

You must inject 2 prefilled Pens to complete your full 300 mg dose.

Throwing away (disposing of) OMVOH Prefilled Pens

Throw away both used prefilled Pens

Storing OMVOH Prefilled Pens

Refrigeration

• In the original carton, store your prefilled pens in the refrigerator between 36°F to 46°F (2°C to 8°C) until the expiration date.
• Do not freeze. Do not use OMVOH if it has been frozen.

Room Temperature

• If needed, your prefilled Pens may be stored at room temperature for up to 2 weeks in the original carton. Do not store above 86°F (30°C).
• When OMVOH has been stored at room temperature, do not return it to the refrigerator.
• Throw away (dispose of) OMVOH if not used within 2 weeks at room temperature.
• Protect your prefilled Pens from light until use.

Do not use the prefilled Pens and throw away (see Throwing away (disposing of) OMVOH Prefilled Pens) if they have been:

Keep OMVOH and all medicines out of the reach of children.

Commonly asked questions

Additional Information:

If you have more questions about how to use the OMVOH prefilled Pens:

Used OMVOH Prefilled Pen disposal

Put the used OMVOH prefilled Pens in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the OMVOH prefilled 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 needles and syringes.

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 recycle your used sharps disposal container.

Read the Medication Guide for OMVOH inside this box to learn more about your medicine.

Manufactured by:

Eli Lilly and Company

Indianapolis, IN 46285, USA

US License Number 1891

OMVOH^TM is a trademark of Eli Lilly and Company.

Copyright © 2025, Eli Lilly and Company. All rights reserved.

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Approved: January 2025

The OMVOH prefilled Pen meets the current dose accuracy and functional requirements of ISO 11608-1 and 11608-5.

OMV-0001-300MG-PEN-IFU-20250115

INSTRUCTIONS FOR USE

OMVOH ^TM (ahm-voh)

(mirikizumab-mrkz)

injection, for subcutaneous use

Prefilled Syringes

One 200 mg/2 mL (100 mg/mL) Prefilled Syringe and One 100 mg/mL Prefilled Syringe for a Full Dose of 300 mg.

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

Before you use the OMVOH prefilled Syringes, read and carefully follow all the step-by-step instructions.

Important information you need to know before injecting OMVOH

• Your healthcare provider should show you how to prepare and inject OMVOH using the prefilled Syringes. Do not inject yourself or someone else until you have been shown how to inject OMVOH.
• Keep this Instructions for Use and read it as needed.
• Each OMVOH prefilled Syringe is for one-time use only.
• Your healthcare provider can help you decide where on your body to inject your dose. Read the Choose and clean your injection sites section of these instructions to help you choose which area can work best for you.
• If you have vision problems, do not use OMVOH prefilled Syringes without help from a caregiver.
• See Storing OMVOH prefilled Syringes for important storage information.

INSTRUCTIONS FOR USE

Before you use the OMVOH prefilled Syringes, read and carefully follow all the step-by-step instructions.

2 Prefilled Syringes = full 300 mg dose

After your first injection, choose a new injection site at least 2 inches away and clean it.

With your second prefilled Syringe, repeat steps 1 to 3 right away after your first injection.

You must inject 2 prefilled Syringes to complete your full 300 mg dose.

Parts of the OMVOH prefilled Syringes

Inject both prefilled Syringes in any order for a full 300 mg dose.

The 200 mg/2 mL (100 mg/mL) prefilled Syringe is larger than the 100 mg/mL prefilled Syringe.

Preparing to inject OMVOH

Gather supplies

Inspect the prefilled Syringes and the medicine

Remove both prefilled Syringes from the carton.

Make sure you have the right medicine.

The medicine inside should be clear. It may be colorless to slightly yellow to slightly brown.

Wait 45 minutes

Do not warm up the prefilled Syringes with a microwave, hot water, or direct sunlight.

With the needle cap on, allow the prefilled Syringes to warm up to room temperature for 45 minutes before injecting.

Choose and clean your injection sites

Your healthcare provider can help you choose the injection sites that are best for you. Clean the injection sites with an alcohol wipe and let them dry.

Injecting OMVOH

1. Uncap the first prefilled Syringe (the prefilled Syringes may be used in any order)

2. Pinch the injection site and insert the needle

3. Inject the medicine

4. Inject the second prefilled Syringe

Choose a new injection site at least 2 inches away and clean it.

With your second prefilled Syringe, repeat steps 1 to 3 right away after your first injection.

You must inject 2 prefilled Syringes to complete your full 300 mg dose.

Throwing away (disposing of) OMVOH Prefilled Syringes

Throw away both used prefilled Syringes

Storing OMVOH Prefilled Syringes

Refrigeration

• In the original carton, store your prefilled Syringes in the refrigerator between 36°F to 46°F (2°C to 8°C) until the expiration date.
• Do not freeze. Do not use OMVOH if it has been frozen.

Room Temperature

• If needed, your prefilled Syringes may be stored at room temperature for up to 2 weeks in the original carton. Do not store above 86°F (30°C).
• When OMVOH has been stored at room temperature, do not return it to the refrigerator.
• Throw away (dispose of) OMVOH if not used within 2 weeks at room temperature.
• Protect your prefilled Syringes from light until use.

Do not use the prefilled Syringes and throw away (see Throwing away (disposing of) OMVOH Prefilled Syringes) if they have been:

Keep OMVOH and all medicines out of the reach of children.

Commonly asked questions

Additional Information:

If you have more questions about how to use the OMVOH prefilled Syringes:

Used OMVOH Prefilled Syringe disposal

Put the used OMVOH prefilled Syringes in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the OMVOH prefilled 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 needles and syringes.

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 recycle your used sharps disposal container.

Read the Medication Guide for OMVOH inside this box to learn more about your medicine.

Manufactured by:

Eli Lilly and Company

Indianapolis, IN 46285, USA

US License Number 1891

OMVOH^TM is a trademark of Eli Lilly and Company.

Copyright © 2025, Eli Lilly and Company. All rights reserved.

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

Approved: January 2025

OMV-0001-300MG-PFS-IFU-20250115

Animal studies have not been conducted to evaluate the carcinogenic or mutagenic potential of mirikizumab-mrkz.

No organ weight or histopathology effects were observed in the male or female reproductive tract in sexually mature cynomolgus monkeys that received subcutaneous mirikizumab-mrkz once weekly for 26 weeks, at a dose of 100 mg/kg (at least 2 times the MRHD of mirikizumab-mrkz, based on exposure comparisons).

• OMVOH for intravenous use is intended for administration by a healthcare provider using aseptic technique.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The solution should be a clear to opalescent, colorless to slightly yellow to slightly brown solution, and free of visible particles. Do not use OMVOH if it is cloudy or there are visible particles.
• Prior to intravenous administration, determine the dose needed based on the patient's indication (see Table 1 below). For Crohn's disease, discard 45 mL of the infusion bag prior to adding vial contents. Withdraw the required amount of solution from the vial(s) using a 18 gauge to 21 gauge needle and transfer to an infusion bag containing 0.9% Sodium Chloride Injection or 5% Dextrose Injection (see Table 1 below). Do not mix with other drugs. Do not dilute or infuse through the same intravenous line with other solutions.
  Table 1: Intravenous Induction Dose and Volume of Diluent Required

  Indication	Intravenous Induction Dose	Number of OMVOH 300mg/15mL vials needed	Volume of 0.9% Sodium Chloride or 5% Dextrose Injection
  Ulcerative colitis	300 mg	1	50 mL, 100 mL, or 250 mL
  Crohn's disease	900 mg	3	100 mL or 250 mL

• Gently invert the infusion bag to mix the contents. Do not shake the prepared infusion bag.
• Connect the intravenous administration set (infusion line) to the prepared infusion bag and prime the line.
• Infuse the diluted solution intravenously over a period of at least 30 minutes for the 300 mg dose; at least 90 minutes for the 900 mg dose. If stored refrigerated, allow the diluted solution in the infusion bag to warm to room temperature prior to the start of the intravenous infusion.
• At the end of the infusion, flush the line with 0.9% Sodium Chloride Injection or 5% Dextrose Injection.
  • Administer the flush at the same infusion rate as used for OMVOH administration.
  • The time required to flush OMVOH solution from the infusion line is in addition to the minimum 30-minute infusion time.

• OMVOH is intended for use under the guidance and supervision of a healthcare professional. Patients may self-inject OMVOH after training in subcutaneous injection technique. Provide proper training to patients and/or caregivers on the subcutaneous injection technique of OMVOH according to the “Instructions for Use”, included with the packaged product.
• Before injection, remove OMVOH prefilled pens or OMVOH prefilled syringes from the refrigerator, and leave at room temperature for 45 minutes.
• Do not shake the prefilled pens or prefilled syringes.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The solution should be a clear to opalescent, colorless to slightly yellow to slightly brown solution, and free of visible particles. Do not use OMVOH if it is cloudy, discolored, or there are visible particles.
• Sites for injection include the abdomen, thigh, and back of the upper arm. Instruct patients to inject in a different location (such as upper arms, thighs or any quadrant of abdomen) than the previous injection. Administration of OMVOH in the back of upper arm may only be performed by another person.
• Do not inject into areas where the skin is tender, bruised, erythematous, or indurated.
• OMVOH does not contain preservatives; therefore, discard any unused product. Do not reuse.
• If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing every 4 weeks.

• Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with OMVOH [see Warnings and Precautions (5.3)].
• Obtain liver enzymes and bilirubin levels prior to initiating treatment with OMVOH [see Warnings and Precautions (5.4)].
• Complete all age-appropriate vaccinations according to current immunization guidelines [see Warnings and Precautions (5.5)].

Induction Dosage

OMV-0005-MG-20251027

Storage and Handling

• Store refrigerated at 2°C to 8°C (36°F to 46°F).
• Do not freeze. Do not use OMVOH if it has been frozen.
• Do not shake.
• Keep OMVOH in the original carton to protect from light until the time of use.
• OMVOH is sterile and preservative-free. Discard any unused portion.
• If needed, the prefilled pen or prefilled syringe may be stored at room temperature up to 30°C (86°F) for up to 2 weeks in the original carton to protect from light. Once OMVOH has been stored at room temperature, do not return to the refrigerator. If these conditions are exceeded, OMVOH must be discarded.
• The vial, prefilled pen, and prefilled syringe are not made with dry natural rubber latex.

PACKAGE LABEL – Omvoh 300 mg Vial Cartons

There are two formulations for this product

NDC 0002-7575-01

15 mL

omvoh^TM

(mirikizumab-mrkz)

injection

300 mg/15 mL

(20 mg/mL)

For Intravenous Infusion After Dilution

Single-Dose Vial - Discard Unused Portion

Dispense enclosed Medication Guide to each patient.

Rx only

omvoh.com

Lilly

Classic Formulation contains the following inactive ingredients:anhydrous citric acid, polysorbate 80, sodium chloride, sodium citrate, and Water for Injection.

Alternate Formulation contains the following inactive ingredients: anhydrous citric acid, histidine, L-histidine hydrochloride monohydrate, mannitol, polysorbate 80, sodium chloride, sodium citrate, and Water for Injection.

Mirikizumab-mrkz is a humanized immunoglobulin G4 (IgG4) variant monoclonal antibody that is directed against the p19 subunit of IL-23 and does not bind IL-12. Mirikizumab-mrkz is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology and it is composed of two identical light chain polypeptides and two identical heavy chain polypeptides with an overall molecular weight of approximately 147 kDa.

OMVOH may increase the risk of infection [see Adverse Reactions (6.1)].

Do not initiate treatment with OMVOH in patients with a clinically important active infection until the infection resolves or is adequately treated.

In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing OMVOH. Instruct patients to seek medical advice if signs or symptoms of clinically important acute or chronic infection occur. If a serious infection develops or an infection is not responding to standard therapy, monitor the patient closely and do not administer OMVOH until the infection resolves.

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with OMVOH.

Do not administer OMVOH to patients with active TB infection. Initiate treatment of latent TB prior to administering OMVOH. Consider anti-TB therapy prior to initiation of OMVOH in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after OMVOH treatment.

In clinical trials, subjects were excluded if they had evidence of active TB, a past history of active TB, or were diagnosed with latent TB at screening.

Avoid use of live vaccines in patients treated with OMVOH. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy with OMVOH, complete all age-appropriate vaccinations according to current immunization guidelines. No data are available on the response to live or non-live vaccines in patients treated with OMVOH.

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

Of the 795 OMVOH-treated subjects in the two ulcerative colitis clinical studies, 64 subjects (8%) were 65 years of age and older, while 10 subjects (1%) were 75 years of age and older. Of the 715 OMVOH-treated subjects in the Crohn's disease clinical study, 22 subjects (3%) were 65 years of age and older, while 6 subjects (1%) were 75 years of age and older). These clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger adult subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects. No clinically meaningful differences in the pharmacokinetics of mirikizumab-mrkz were observed in subjects 65 years of age and older compared to younger adult subjects [see Clinical Pharmacology (12.3)].

A case of drug-induced liver injury (alanine aminotransferase [ALT] 18x the upper limit of normal (ULN), aspartate aminotransferase [AST] 10x ULN, and total bilirubin 2.4x ULN) in conjunction with pruritus was reported in a clinical trial subject following a longer than recommended induction regimen. OMVOH was discontinued. Liver test abnormalities eventually returned to baseline.

Evaluate liver enzymes and bilirubin at baseline and for at least 24 weeks of treatment. Monitor thereafter according to routine patient management.

Consider other treatment options in patients with evidence of liver cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.

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, including those of mirikizumab-mrkz or of other mirikizumab products.

During the 52-week treatment period in studies UC-1 and UC-2, 23% (88/378) of OMVOH-treated subjects at the recommended dosage and evaluable for assessment, developed anti-mirikizumab-mrkz antibodies (referred to as anti-drug antibodies (ADA)). Of those who developed ADA, 33/88 (38%) developed titers ≥1:160. Of these 33 OMVOH-treated subjects, 10 had reduced serum trough concentrations of mirikizumab-mrkz compared to subjects who did not develop anti-mirikizumab-mrkz antibodies, and 5 of these 10 subjects did not achieve clinical response at Week 52. There is insufficient data to assess whether the observed ADA-associated pharmacokinetic changes reduced effectiveness. There is no identified clinically significant effect of ADA on the safety of OMVOH over the treatment duration of 52-weeks.

During the 52-week treatment period in study CD-1, 13% (79/622) of OMVOH-treated subjects at the recommended dosage and evaluable for assessment developed ADA. There is no identified clinically significant effect of ADA on the pharmacokinetics, effectiveness, or safety of OMVOH over the treatment duration of 52-weeks.

OMVOH is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients [see Warnings and Precautions (5.1)].

The following topics are also discussed in detail in the Warnings and Precautions section:

• Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
• Infections [see Warnings and Precautions (5.2)]
• Tuberculosis [see Warnings and Precautions (5.3)]
• Hepatotoxicity [see Warnings and Precautions (5.4)]

The safety and efficacy of OMVOH was evaluated in a randomized, double-blind, placebo-controlled study [CD-1 (NCT03926130)] in adult subjects with moderately to severely active Crohn's disease who had an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine, and methotrexate), and/or biologics (TNF blockers, integrin receptor antagonists).

In CD-1, the efficacy population consisted of 679 subjects who were randomized 3:1 at Week 0 to receive OMVOH 900 mg by intravenous infusion at Week 0, Week 4, and Week 8 followed by a dosage of 300 mg by subcutaneous injection at Week 12 and then every 4 weeks for 40 weeks, or placebo. Subjects had a mean age of 36 years (range 18 to 74 years); 42% were female; and 71% identified as White, 25% as Asian, <1% as American Indian or Alaska Native, 1% as Black or African American, and 2% as another racial group or did not report their racial group. Subjects were permitted to use stable doses of oral corticosteroids (prednisone ≤30 mg/day or equivalent, extended-release budesonide 9 mg/day), immunomodulators (6-mercatopurine, azathioprine, or methotrexate) and/or aminosalicylates. At baseline, 31% of subjects were receiving oral corticosteroids, 26% were receiving immunomodulators, and 44% were receiving aminosalicylates.

At baseline, 47% had a loss of response, inadequate response, or intolerance to one or more biologic therapy.

Disease activity at baseline was assessed by the Crohn's Disease Activity Index (CDAI) and the Simple Endoscopic Score for Crohn's disease (SES-CD). Moderately to severely active CD was defined by a CDAI of ≥220 and an SES-CD ≥7 (centrally read) for subjects with ileal-colonic disease or ≥4 for subjects with isolated ileal disease. At baseline, subjects had a median CDAI of 329 and SES-CD of 12.

The coprimary endpoints of clinical remission by CDAI and endoscopic response by SES-CD were assessed at Week 52. Secondary efficacy endpoints included endoscopic response at Week 12 and endoscopic remission and corticosteroid-free clinical remission at Week 52 (see Table 9).

In both study UC-1 (induction) and study UC-2 (maintenance), a positive relationship was observed between Mirikizumab-mrkz average concentration and rates of clinical remission and clinical response [see Clinical Studies (14.1)].

Mirikizumab exposure response relationships have not been fully characterized in subjects with Crohn's disease.

Mirikizumab-mrkz exhibited linear pharmacokinetics with dose-proportional increase in exposure over a dose range of 60 to 2400 mg given as an intravenous injection or over a dose range of 200 to 400 mg given as a subcutaneous injection, in healthy volunteers. There was no apparent accumulation of mirikizumab-mrkz concentrations in serum over time when administered as a subcutaneous injection every 4 weeks to subjects with ulcerative colitis or Crohn's disease. The estimated exposure parameters of mirikizumab-mrkz at steady state are summarized in Tables 5 for ulcerative colitis and 6 for Crohn's disease.

Increased concentrations of cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation associated with certain diseases including Crohn's disease may suppress the formation of CYP450 enzymes. Therapeutic proteins, including mirikizumab-mrkz, that decrease the concentrations of these pro-inflammatory cytokines may increase the formation of CYP450 enzymes resulting in decreased CYP450 substrate exposure. Upon initiation or discontinuation of OMVOH in patients treated with concomitant CYP450 substrates, monitor drug concentrations or other therapeutic parameters, and adjust the dosage of the CYP450 substrate as needed. See the prescribing information of specific CYP450 substrates.

OMVOH is indicated for the treatment of:

• moderately to severely active ulcerative colitis in adults.
• moderately to severely active Crohn's disease in adults.

The safety and efficacy of OMVOH was evaluated in two randomized, double-blind, placebo-controlled clinical studies, one induction study [UC-1 (NCT03518086)] and one maintenance study [UC-2 (NCT03524092)], in adult subjects with moderately to severely active ulcerative colitis who had inadequate response, loss of response, or failed to tolerate any of the following: corticosteroids, 6-mercaptopurine, azathioprine, biologic therapy (TNF blocker, vedolizumab), or tofacitinib. The 12-week intravenous induction study (UC-1) was followed by the 40-week subcutaneous randomized withdrawal maintenance study (UC-2).

Mirikizumab-mrkz is a humanized IgG4 monoclonal antibody that selectively binds to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor.

IL-23 is involved in mucosal inflammation and affects the differentiation, expansion, and survival of T cell subsets, and innate immune cell subsets, which represent sources of pro-inflammatory cytokines. Research in animal models has shown that pharmacologic inhibition of IL-23p19 can ameliorate intestinal inflammation.

Mirikizumab-mrkz inhibits the release of pro-inflammatory cytokines and chemokines.

• Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis and infusion-related reactions, have been reported. If a severe hypersensitivity reaction occurs, discontinue and initiate appropriate treatment. (5.1)
• Infections: OMVOH may increase the risk of infection. Do not initiate treatment with OMVOH in patients with a clinically important active infection until the infection resolves or is adequately treated. If a serious infection develops, do not administer OMVOH until the infection resolves. (5.2)
• Tuberculosis: Do not administer OMVOH to patients with active TB infection. Monitor patients receiving OMVOH for signs and symptoms of active TB during and after treatment. (5.3)
• Hepatotoxicity: Drug-induced liver injury has been reported. Monitor liver enzymes and bilirubin levels at baseline and for at least 24 weeks of treatment and thereafter according to routine patient management. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. (5.4)
• Immunizations: Avoid use of live vaccines. (5.5)

Prior to Treatment Initiation

• Evaluate patients for tuberculosis (TB) infection. (2.1, 5.3)
• Obtain liver enzymes and bilirubin levels. (2.1, 5.4)
• Complete all age-appropriate vaccinations according to current immunization guidelines. (2.1, 5.5)

Recommended Dosage for Ulcerative Colitis

• Induction Dosage: Week 0, Week 4, and Week 8: Infuse 300 mg intravenously over at least 30 minutes. (2.2)
• Maintenance Dosage: Week 12 and every 4 weeks thereafter: Inject 200 mg subcutaneously (given as either one injection of 200 mg or as two consecutive injections of 100 mg each). (2.2)

Recommended Dosage for Crohn's Disease

• Induction Dosage: Week 0, Week 4, and Week 8: Infuse 900 mg intravenously over at least 90 minutes. (2.3)
• Maintenance Dosage: Week 12 and every 4 weeks thereafter: Inject 300 mg subcutaneously (given as two consecutive injections of 100 mg and 200 mg in any order). (2.3)

Preparation and Administration Instructions

• See the full prescribing information for preparation, administration and storage information for intravenous infusion and subcutaneous injection. (2.2, 2.3, 2.4, 2.5)

OMVOH is a clear to opalescent, colorless to slightly yellow to slightly brown solution available as:

• Intravenous Infusion:
  
  Injection: 300 mg/15 mL (20 mg/mL) solution in a single-dose vial
• Subcutaneous Use:
  
  Injection: 100 mg/mL solution in a single-dose prefilled pen
  
  Injection: 100 mg/mL solution in a single-dose prefilled syringe
  
  Injection: 200 mg/2 mL solution in a single-dose prefilled pen
  
  Injection: 200 mg/2 mL (100 mg/mL) solution in a single-dose prefilled syringe

Serious hypersensitivity reactions, including anaphylaxis during intravenous infusion, have been reported with OMVOH administration. Infusion-related hypersensitivity reactions, including mucocutaneous erythema and pruritus, were reported during induction [see Adverse Reactions (6.1)]. If a severe hypersensitivity reaction occurs, discontinue OMVOH immediately and initiate appropriate treatment.

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

OMVOH (mirikizumab-mrkz) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow to slightly brown solution for intravenous infusion or subcutaneous injection.

OMVOH is supplied in indication specific packaging as:

Note to Pharmacist: The entire carton of 2 prefilled pen or 2 prefilled syringes are to be dispensed as a unit.

Each 100 mg/mL single-dose prefilled pen or prefilled syringe consists of a 1 mL glass syringe with a fixed 27-gauge ½ inch needle.

Each 200 mg/2 mL single-dose prefilled pen or 200 mg/2 mL (100 mg/mL) prefilled syringe consists of a 2 mL glass syringe with a fixed 27-gauge 8 mm needle.

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

Manufactured by:

Eli Lilly and Company

Indianapolis, IN 46285, USA

US License Number 1891

OMVOH™ is a trademark of Eli Lilly and Company.

Copyright © 2023, 2025, Eli Lilly and Company. All rights reserved.

Revised: October 2025

The OMVOH prefilled Pen meets the current dose accuracy and functional requirements of ISO 11608-1 and 11608-5.

OMV-0005-IFU-PEN-20251023

Throwing away (disposing of) OMVOH prefilled Pen

Manufactured by:

Eli Lilly and Company

Indianapolis, IN 46285, USA

US License Number 1891

OMVOH™ is a trademark of Eli Lilly and Company.

Copyright © 2025, Eli Lilly and Company. All rights reserved.

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

Approved: October 2025

The OMVOH prefilled Pen meets the current dose accuracy and functional requirements of ISO 11608-1 and 11608-5.

OMV-0001-200MG-PEN-IFU-20251023

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

Manufactured by:

Eli Lilly and Company

Indianapolis, IN 46285, USA

US License Number 1891

OMVOH^TM is a trademark of Eli Lilly and Company.

Copyright © 2024, 2025, Eli Lilly and Company. All rights reserved.

Revised: October 2025

OMV-0003-IFU-PFS-20251023

Manufactured by:

Eli Lilly and Company

Indianapolis, IN 46285, USA

US License Number 1891

OMVOH is a trademark of Eli Lilly and Company.

Copyright © 2025, Eli Lilly and Company. All rights reserved.

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

Approved: October 2025

OMV-0001-200MG-PFS-IFU-20251023

INSTRUCTIONS FOR USE

OMVOH ^TM (ahm-voh)

(mirikizumab-mrkz)

injection, for subcutaneous use

Prefilled Pens

One 200 mg/2 mL Prefilled Pen and one 100 mg/mL Prefilled Pen for a full dose of 300 mg

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

Before you use the OMVOH prefilled Pens, read and carefully follow all the step-by-step instructions.

Important information you need to know before injecting OMVOH

• Your healthcare provider should show you how to prepare and inject OMVOH using the prefilled Pens. Do not inject yourself or someone else until you have been shown how to inject OMVOH.
• Keep this Instructions for Use and read it as needed.
• Each OMVOH prefilled Pen is for one-time use only.
• The OMVOH prefilled Pen contains glass parts. Handle it carefully. If you drop it on a hard surface, do not use it. Use a new OMVOH prefilled Pen for your injection.
• Your healthcare provider can help you decide where on your body to inject your dose. Read the Choose and clean your injection sites section of these instructions to help you choose which area can work best for you.
• If you have vision or hearing problems, do not use OMVOH prefilled Pens without help from a caregiver.
• See Storing OMVOH Prefilled Pens for important storage information.

INSTRUCTIONS FOR USE

Before you use the OMVOH prefilled Pens, read and carefully follow all the step-by-step instructions.

2 Prefilled Pens = full 300 mg dose

After your first injection, choose a new injection site at least 2 inches (5 centimeters) away and clean it.

With your second prefilled Pen, repeat steps 1 to 3 right away after your first injection.

You must inject 2 prefilled Pens to complete your full 300 mg dose.

Parts of the OMVOH Prefilled Pens

Inject both prefilled Pens in any order for a full 300 mg dose.

The 200 mg/2 mL prefilled Pen is larger than the 100 mg/mL prefilled Pen.

Preparing to inject OMVOH

Gather supplies

Inspect the prefilled Pens and the medicine

Remove both prefilled Pens from the carton.

Make sure you have the right medicine.

The medicine inside should be clear. It may be colorless to slightly yellow to slightly brown.

Wait 45 minutes

Do not warm up the prefilled Pens with a microwave, hot water, or direct sunlight.

With the gray base cap on, allow the prefilled Pens to warm up to room temperature for 45 minutes before injecting.

Choose and clean your injection sites

Your healthcare provider can help you choose the injection sites that are best for you. Clean the injection sites with an alcohol wipe and let them dry.

Injecting OMVOH

1. Uncap the first prefilled Pen (the prefilled Pens may be used in any order)

2. Place and unlock

3. Press and hold for 15 seconds

4. Inject the second prefilled Pen

Choose a new injection site at least 2 inches away and clean it.

With your second prefilled Pen, repeat steps 1 to 3 right away after your first injection.

You must inject 2 prefilled Pens to complete your full 300 mg dose.

Throwing away (disposing of) OMVOH Prefilled Pens

Throw away both used prefilled Pens

Storing OMVOH Prefilled Pens

Refrigeration

• In the original carton, store your prefilled pens in the refrigerator between 36°F to 46°F (2°C to 8°C) until the expiration date.
• Do not freeze. Do not use OMVOH if it has been frozen.

Room Temperature

• If needed, your prefilled Pens may be stored at room temperature for up to 2 weeks in the original carton. Do not store above 86°F (30°C).
• When OMVOH has been stored at room temperature, do not return it to the refrigerator.
• Throw away (dispose of) OMVOH if not used within 2 weeks at room temperature.
• Protect your prefilled Pens from light until use.

Do not use the prefilled Pens and throw away (see Throwing away (disposing of) OMVOH Prefilled Pens) if they have been:

Keep OMVOH and all medicines out of the reach of children.

Commonly asked questions

Additional Information:

If you have more questions about how to use the OMVOH prefilled Pens:

Used OMVOH Prefilled Pen disposal

Put the used OMVOH prefilled Pens in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the OMVOH prefilled 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 needles and syringes.

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 recycle your used sharps disposal container.

Read the Medication Guide for OMVOH inside this box to learn more about your medicine.

Manufactured by:

Eli Lilly and Company

Indianapolis, IN 46285, USA

US License Number 1891

OMVOH^TM is a trademark of Eli Lilly and Company.

Copyright © 2025, Eli Lilly and Company. All rights reserved.

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Approved: January 2025

The OMVOH prefilled Pen meets the current dose accuracy and functional requirements of ISO 11608-1 and 11608-5.

OMV-0001-300MG-PEN-IFU-20250115

INSTRUCTIONS FOR USE

OMVOH ^TM (ahm-voh)

(mirikizumab-mrkz)