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

Subcutaneous Injection

• Inject MERILOG subcutaneously within 5–10 minutes before a meal into the abdominal area, thigh, buttocks or upper arm.
• Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions (5.2) and Adverse Reactions (6.1, 6.3)].
• The MERILOG SoloStar prefilled pen dials in 1-unit increments.
• Generally use MERILOG (administered by subcutaneous injection) in regimens with an intermediate- or long-acting insulin.

Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions (5.3, 5.6)]. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.

Insulin aspart-szjj is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Escherichia coli. Insulin aspart-szjj has a molecular weight of 5825.8 Da.

MERILOG (insulin aspart-szjj) injection is a sterile, clear, and colorless solution for subcutaneous use. Each mL contains 100 units of insulin aspart-szjj and the inactive ingredients: 1.72 mg metacresol, 1.50 mg phenol, 0.02 mg polysorbate 20, 6.80 mg sodium chloride, 0.04 mg zinc chloride and Water for Injection, USP. MERILOG has a pH of 7.0–7.8. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.

All insulins, including insulin aspart products, can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentration).

Hypoglycemia is the most common adverse reaction of all insulins, including insulin aspart products. Severe hypoglycemia can cause seizures, may lead to unconsciousness, may be life threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery).

Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers) [see Drug Interactions (7)], or in patients who experience recurrent hypoglycemia.

MERILOG (insulin aspart-szjj) injection 100 units/mL (U-100) is available as a clear and colorless solution in:

The MERILOG SoloStar prefilled pen dials in 1-unit increments.

Needles are not included in MERILOG SoloStar packs. Only use needles that are compatible for use with MERILOG SoloStar which are sold separately, including needles from Becton, Dickinson and company (BD) (such as BD Ultra-Fine^®), Ypsomed (such as Clickfine^®), and Owen Mumford (such as Unifine^® Pentips^®).

The safety and effectiveness of MERILOG to improve glycemic control have been established in pediatric patients with diabetes mellitus. Use of MERILOG for this indication is supported by evidence from an adequate and well-controlled study of insulin aspart in 283 pediatric patients with type 1 diabetes mellitus aged 6 to 18 years and from studies in adults with diabetes mellitus [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14)].

Of the total number of patients (n=1,375) treated with insulin aspart in 3 controlled clinical studies, 2.6% (n=36) were 65 years of age or over. One-half of these patients had type 1 diabetes (18/1285) and the other half had type 2 diabetes (18/90). The HbA_1c response to insulin aspart, as compared to regular human insulin, did not differ by age.

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other insulin aspart products may be misleading.

In a 6-month study with a 6-month extension in adult subjects with type 1 diabetes, 99.8% of patients who received insulin aspart were positive for anti-insulin antibodies (AIA) at least once during the study, including 97.2% that were positive at baseline. A total of 92.1% of patients who received insulin aspart were positive for anti-drug antibodies (ADA) at least once during the study, including 64.6% that were positive at baseline.

In a phase 3 type 1 diabetes clinical trial of insulin aspart, initial increase in titers of antibodies to insulin, followed by a decrease to baseline values, was observed in regular human insulin and insulin aspart treatment groups with similar incidences. These antibodies did not cause deterioration in glycemic control or necessitate increases in insulin dose.

MERILOG is contraindicated:

• During episodes of hypoglycemia [see Warnings and Precautions (5.3)].
• In patients with hypersensitivity to insulin aspart products or any of the excipients in MERILOG [see Warnings and Precautions (5.5)].

The following adverse reactions are also discussed elsewhere:

• Hypoglycemia [see Warnings and Precautions (5.3)]
• Hypoglycemia Due to Medication Errors [see Warnings and Precautions (5.4)]
• Hypersensitivity Reactions [see Warnings and Precautions (5.5)]
• Hypokalemia [see Warnings and Precautions (5.6)]

The table below presents clinically significant drug interactions with MERILOG.

Patients with renal impairment may be at increased risk of hypoglycemia and may require more frequent MERILOG dose adjustment and more frequent blood glucose monitoring [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].

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

Read this Instructions for Use before you start taking MERILOG and each time you get a new MERILOG 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 MERILOG syringes with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

Supplies needed to give your injection

• a MERILOG 10 mL vial
• a U-100 insulin syringe and needle
• 2 alcohol swabs
• 1 sharps container for throwing away used needles and syringes. See "Disposing of used needles and syringes" at the end of these instructions.

Preparing your MERILOG dose

• Wash your hands with soap and water or with alcohol.
• Check the MERILOG label to make sure you are taking the right type of insulin. This is especially important if you use more than 1 type of insulin.
• Check that the insulin is clear and colorless. Do not use the vial if the insulin looks cloudy, colored or contains particles.
• Do not use MERILOG after the expiration date stamped on the label or 28 days after you first use it.
• Always use a syringe that is marked for U-100 insulin. If you use a syringe other than a U-100 insulin syringe, you may get the wrong dose of insulin.
• Always use a new syringe or needle for each injection to help maintain sterility and prevent 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.

Need help?

If you have any questions about your vial or about diabetes, ask your healthcare provider, or call sanofi-aventis at 1-800-633-1610.

Step 1:

If you are using a new vial, remove the protective cap. Do not remove the stopper (see Figure A ).

Step 2:

Wipe the top of the vial with an alcohol swab. You do not have to shake the vial of MERILOG before use (see Figure B ).

Step 3:

Draw air into the syringe equal to your insulin dose (see Figure C ). Put the needle through the rubber top of the vial and push the plunger to inject the air into the vial (see Figure D ).

Step 4:

Leave the syringe in the vial and turn both upside down. Hold the syringe and vial firmly in one hand. Make sure the tip of the needle is in the insulin. With your free hand, pull the plunger to withdraw the correct dose into the syringe (see Figure E ).

Step 5:

Before you take the needle out of the vial, check the syringe for air bubbles. If bubbles are in the syringe, hold the syringe straight up and tap the side of the syringe until the bubbles float to the top. Push the bubbles out with the plunger and draw insulin back in until you have the correct dose (see Figure F ).

Step 6:

Remove the needle from the vial. Do not let the needle touch anything. You are now ready to inject.

Giving your MERILOG injection with a syringe

• Inject your insulin exactly as your healthcare provider has shown you.
• MERILOG starts acting fast. You should eat a meal within 5 to 10 minutes after you take your dose of MERILOG.

Step 7:

• Choose your injection site: MERILOG is injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs) or upper arms (see Figure G ).
• Do not use the exact same spot for each injection. Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting pits in the skin or thickened skin (lipodystrophy) and skin with lumps (localized cutaneous amyloidosis) 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.
  
  
                           (Figure G)

• Wipe the skin with an alcohol swab to clean the injection site. Let the injection site dry before you inject your dose (see Figure H ).
  
  
        (Figure H)

Step 8:

• Pinch the skin.
• Insert the needle in the way your healthcare provider showed you.
• Release the skin.
• Slowly push in the plunger of the syringe all the way, making sure you have injected all the insulin.
• Leave the needle in the skin for about 10 seconds (see Figure I ).
  
  
        (Figure I)

Step 9:

• Pull the needle straight out of your skin.
• Gently press the injection site for several seconds. Do not rub the area.
• Do not recap the used needle. Recapping the needle can lead to a needle-stick injury.

Disposing of used needles and syringes

• Put your used needles and syringes in a 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 a FDA-cleared sharps 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.

How should I store MERILOG?

Unopened (not in-use) MERILOG vials

• Store unused MERILOG vials in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not freeze MERILOG.
• Keep MERILOG away from direct heat and light.
• If a vial has been frozen or overheated, throw it away.
• Unopened vials can be used until the expiration date on the carton and label if they have been stored in the refrigerator.
• Unopened vials should be thrown away after 28 days if they are stored at room temperature.

After MERILOG vials have been opened (in-use)

• Store in-use (opened) MERILOG vials in a refrigerator between 36°F to 46°F (2°C to 8°C) or at room temperature below 86°F (30°C) for up to 28 days.
• Do not freeze MERILOG.
• Do not expose MERILOG to excessive heat or light.
• If a vial has been frozen, throw it away.
• The MERILOG vial you are using should be thrown away after 28 days, even if it still has insulin left in it.

Manufactured by:

sanofi-aventis U.S. LLC

Morristown, NJ 07960

A SANOFI COMPANY

U.S. License No. 1752

©2025 Sanofi. All rights reserved.

All trademarks mentioned in this document are the property of the Sanofi group.

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

Approved: May 2025

Pharmacokinetics of subcutaneous administration of insulin aspart is presented below.

Patients with hepatic impairment may be at increased risk of hypoglycemia and may require more frequent MERILOG dose adjustment and more frequent blood glucose monitoring [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].

MERILOG is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

The primary activity of insulin, including insulin aspart products is the regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.

Dispense in the original sealed carton with the enclosed Instructions for Use.

Store unused MERILOG in a refrigerator between 2°C to 8°C (36°F to 46°F). Do not freeze MERILOG and do not use MERILOG if it has been frozen. Do not expose MERILOG to excessive heat or light.

Do not withdraw MERILOG into a syringe and store for later use.

Always remove and discard the needle after each injection from the MERILOG SoloStar prefilled pen and store without a needle attached.

The storage conditions are summarized in the following table:

• Individualize the dosage of MERILOG based on the patient's metabolic needs, blood glucose monitoring results and glycemic control goal.
• Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness [see Warnings and Precautions (5.2, 5.3) and Use in Specific Populations (8.6, 8.7)].
• When switching from another insulin to MERILOG, a different dosage of MERILOG may be needed [see Warnings and Precautions (5.2)].
• During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions (5.2)].

• Never share a MERILOG SoloStar prefilled pen between patients, even if the needle is changed (5.1).
• Hyperglycemia or hypoglycemia with changes in insulin regimen: Make changes to a patient's insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring (5.2).
• Hypoglycemia: May be life-threatening. Increase frequency of glucose monitoring with changes to: insulin dosage, concomitantly administered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairments and hypoglycemia unawareness (5.3).
• Medication Errors: Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection (5.4).
• Hypersensitivity reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, may occur. Discontinue MERILOG, treat, and monitor, if indicated (5.5).
• Hypokalemia: May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated (5.6).
• Fluid retention and heart failure with concomitant use of thiazolidinediones (TZDs): Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs (5.7).

See Full Prescribing Information for important preparation, administration, and dosage instructions (2.1, 2.2, 2.3, 2.4, 2.5).

• Subcutaneous injection (2.2):
  • Inject subcutaneously within 5–10 minutes before a meal into the abdominal area, thigh, buttocks or upper arm.
  • Rotate injection sites within the same region from one injection to the next to reduce risk of lipodystrophy and localized cutaneous amyloidosis.
  • Should generally be used in regimens with an intermediate- or long-acting insulin.
• Individualize and adjust the dosage of MERILOG based on the individual's metabolic needs, blood glucose monitoring results and glycemic control goal (2.3).
• Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness (2.3).

Injection: 100 units/mL (U-100) is a clear and colorless solution available as:

• 10 mL multiple-dose vial
• 3 mL single-patient-use MERILOG SoloStar^® prefilled pen

The following adverse reactions have been identified during post-approval use of insulin aspart products. Because these adverse reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Medication errors have been reported in which other insulins have been accidentally substituted for insulin aspart products.

Localized cutaneous amyloidosis at the injection site has occurred with insulin aspart products. Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including insulin aspart products. If hypersensitivity reactions occur, discontinue MERILOG; treat per standard of care and monitor until symptoms and signs resolve [see Adverse Reactions (6)]. MERILOG is contraindicated in patients who have had hypersensitivity reactions to insulin aspart products or any of the excipients in MERILOG [see Contraindications (4)].

Because clinical trials are conducted under widely varying designs, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice. The safety of insulin aspart was evaluated in two treat-to-target trials of 6 months duration, conducted in patients with type 1 diabetes or type 2 diabetes [see Clinical Studies (14)].

The data in Table 1 reflect the exposure of 596 patients with type 1 diabetes to insulin aspart in one clinical trial with a mean exposure duration to insulin aspart of 24 weeks. The mean age was 39 years. Fifty-one percent were male, 94% were Caucasian, 2% were Black and 4% were other races. The mean body mass index (BMI) was 25.6 kg/m². The mean duration of diabetes was 15.7 years and the mean HbA_1c at baseline was 7.9%.

The data in Table 2 reflect the exposure of 91 patients with type 2 diabetes to insulin aspart in one clinical trial with a mean exposure duration to insulin aspart of 24 weeks. The mean age was 57 years. Sixty-three percent were male, 76% were Caucasian, 9% were Black and 15% were other races. The mean BMI was 29.7 kg/m². The mean duration of diabetes was 12.7 years and the mean HbA_1c at baseline was 8.1%.

Common adverse reactions were defined as events that occurred in ≥5%, excluding hypoglycemia, of the population studied. Common adverse events that occurred at the same rate or greater for insulin aspart-treated patients than in comparator-treated patients during clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus (other than hypoglycemia) are listed in Table 1 and Table 2, respectively.

The safety and effectiveness of subcutaneous insulin aspart were compared to regular human insulin in 596 type 1 diabetes adult, 187 pediatric type 1 diabetes, and 91 adult type 2 diabetes patients using NPH as basal insulin (see Tables 3, 4, 5). The reduction in glycated hemoglobin (HbA_1c) was similar to regular human insulin.

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

Accidental mix-ups between insulin products have been reported. To avoid medication errors between MERILOG and other insulins, instruct patients to always check the insulin label before each injection.

Rx only

NDC 0024-5928-05

Merilog™ SoloStar^®

(insulin aspart-szjj) injection

For Single Patient Use Only

100 units/mL (U-100)

For subcutaneous injection only

Do not mix with other insulins

Needles not included

Dispense in this sealed carton

Five 3 mL Prefilled Pens

sanofi

In standard biological assays in mice and rabbits, one unit of insulin aspart has the same glucose-lowering effect as one unit of regular human insulin.

NDC 0024-5927-00

Rx only

Merilog™

(insulin aspart-szjj) injection

100 units/mL (U-100)

For subcutaneous injection only

Use only with a U-100 syringe

One 10 mL multiple-dose vial

sanofi

Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia; increased frequency of blood glucose monitoring is recommended. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended.

• Dosage modification may be needed when MERILOG is used concomitantly with certain drugs [see Drug Interactions (7)].

Do not mix MERILOG with any other insulin.

Standard 2-year carcinogenicity studies in animals have not been performed to evaluate the carcinogenic potential of insulin aspart products. In 52-week studies, Sprague-Dawley rats were dosed subcutaneously with insulin aspart at 10, 50, and 200 units/kg/day (approximately 2, 8, and 32 times the human subcutaneous dose of 1.0 units/kg/day, based on units/body surface area, respectively). At a dose of 200 units/kg/day, insulin aspart increased the incidence of mammary gland tumors in females when compared to untreated controls. The relevance of these findings to humans is unknown.

Insulin aspart was not genotoxic in the following tests: Ames test, mouse lymphoma cell forward gene mutation test, human peripheral blood lymphocyte chromosome aberration test, in vivo micronucleus test in mice, and in ex vivo UDS test in rat liver hepatocytes.

In fertility studies in male and female rats, at subcutaneous doses up to 200 units/kg/day (approximately 32 times the human subcutaneous dose, based on units/body surface area), no direct adverse effects on male and female fertility, or general reproductive performance of animals was observed.

• Always check insulin labels before administration [see Warnings and Precautions (5.4)].
• Inspect MERILOG visually before use. It should appear clear and colorless. Do not use MERILOG if particulate matter or coloration is seen.
• Use MERILOG SoloStar prefilled pen with caution in patients with visual impairment who may rely on audible clicks to dial their dose.

MERILOG SoloStar prefilled pen should never be shared between patients, even if the needle is changed. Patients using MERILOG vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.

Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia [see Warnings and Precautions (5.3)] or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia [see Adverse Reactions (6.1, 6.3)].

Make any changes to a patient's insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.

Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including MERILOG, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.

Subcutaneous Injection

• Inject MERILOG subcutaneously within 5–10 minutes before a meal into the abdominal area, thigh, buttocks or upper arm.
• Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions (5.2) and Adverse Reactions (6.1, 6.3)].
• The MERILOG SoloStar prefilled pen dials in 1-unit increments.
• Generally use MERILOG (administered by subcutaneous injection) in regimens with an intermediate- or long-acting insulin.

Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions (5.3, 5.6)]. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.

Insulin aspart-szjj is a rapid-acting human insulin analog homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Escherichia coli. Insulin aspart-szjj has a molecular weight of 5825.8 Da.

MERILOG (insulin aspart-szjj) injection is a sterile, clear, and colorless solution for subcutaneous use. Each mL contains 100 units of insulin aspart-szjj and the inactive ingredients: 1.72 mg metacresol, 1.50 mg phenol, 0.02 mg polysorbate 20, 6.80 mg sodium chloride, 0.04 mg zinc chloride and Water for Injection, USP. MERILOG has a pH of 7.0–7.8. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.

All insulins, including insulin aspart products, can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentration).

Hypoglycemia is the most common adverse reaction of all insulins, including insulin aspart products. Severe hypoglycemia can cause seizures, may lead to unconsciousness, may be life threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery).

Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers) [see Drug Interactions (7)], or in patients who experience recurrent hypoglycemia.

MERILOG (insulin aspart-szjj) injection 100 units/mL (U-100) is available as a clear and colorless solution in:

The MERILOG SoloStar prefilled pen dials in 1-unit increments.

Needles are not included in MERILOG SoloStar packs. Only use needles that are compatible for use with MERILOG SoloStar which are sold separately, including needles from Becton, Dickinson and company (BD) (such as BD Ultra-Fine^®), Ypsomed (such as Clickfine^®), and Owen Mumford (such as Unifine^® Pentips^®).

The safety and effectiveness of MERILOG to improve glycemic control have been established in pediatric patients with diabetes mellitus. Use of MERILOG for this indication is supported by evidence from an adequate and well-controlled study of insulin aspart in 283 pediatric patients with type 1 diabetes mellitus aged 6 to 18 years and from studies in adults with diabetes mellitus [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14)].

Of the total number of patients (n=1,375) treated with insulin aspart in 3 controlled clinical studies, 2.6% (n=36) were 65 years of age or over. One-half of these patients had type 1 diabetes (18/1285) and the other half had type 2 diabetes (18/90). The HbA_1c response to insulin aspart, as compared to regular human insulin, did not differ by age.

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other insulin aspart products may be misleading.

In a 6-month study with a 6-month extension in adult subjects with type 1 diabetes, 99.8% of patients who received insulin aspart were positive for anti-insulin antibodies (AIA) at least once during the study, including 97.2% that were positive at baseline. A total of 92.1% of patients who received insulin aspart were positive for anti-drug antibodies (ADA) at least once during the study, including 64.6% that were positive at baseline.

In a phase 3 type 1 diabetes clinical trial of insulin aspart, initial increase in titers of antibodies to insulin, followed by a decrease to baseline values, was observed in regular human insulin and insulin aspart treatment groups with similar incidences. These antibodies did not cause deterioration in glycemic control or necessitate increases in insulin dose.

MERILOG is contraindicated:

• During episodes of hypoglycemia [see Warnings and Precautions (5.3)].
• In patients with hypersensitivity to insulin aspart products or any of the excipients in MERILOG [see Warnings and Precautions (5.5)].

The following adverse reactions are also discussed elsewhere:

• Hypoglycemia [see Warnings and Precautions (5.3)]
• Hypoglycemia Due to Medication Errors [see Warnings and Precautions (5.4)]
• Hypersensitivity Reactions [see Warnings and Precautions (5.5)]
• Hypokalemia [see Warnings and Precautions (5.6)]

The table below presents clinically significant drug interactions with MERILOG.

Patients with renal impairment may be at increased risk of hypoglycemia and may require more frequent MERILOG dose adjustment and more frequent blood glucose monitoring [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].

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

Read this Instructions for Use before you start taking MERILOG and each time you get a new MERILOG 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 MERILOG syringes with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

Supplies needed to give your injection

• a MERILOG 10 mL vial
• a U-100 insulin syringe and needle
• 2 alcohol swabs
• 1 sharps container for throwing away used needles and syringes. See "Disposing of used needles and syringes" at the end of these instructions.

Preparing your MERILOG dose

• Wash your hands with soap and water or with alcohol.
• Check the MERILOG label to make sure you are taking the right type of insulin. This is especially important if you use more than 1 type of insulin.
• Check that the insulin is clear and colorless. Do not use the vial if the insulin looks cloudy, colored or contains particles.
• Do not use MERILOG after the expiration date stamped on the label or 28 days after you first use it.
• Always use a syringe that is marked for U-100 insulin. If you use a syringe other than a U-100 insulin syringe, you may get the wrong dose of insulin.
• Always use a new syringe or needle for each injection to help maintain sterility and prevent 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.

Need help?

If you have any questions about your vial or about diabetes, ask your healthcare provider, or call sanofi-aventis at 1-800-633-1610.

Step 1:

If you are using a new vial, remove the protective cap. Do not remove the stopper (see Figure A ).

Step 2:

Wipe the top of the vial with an alcohol swab. You do not have to shake the vial of MERILOG before use (see Figure B ).

Step 3:

Draw air into the syringe equal to your insulin dose (see Figure C ). Put the needle through the rubber top of the vial and push the plunger to inject the air into the vial (see Figure D ).

Step 4:

Leave the syringe in the vial and turn both upside down. Hold the syringe and vial firmly in one hand. Make sure the tip of the needle is in the insulin. With your free hand, pull the plunger to withdraw the correct dose into the syringe (see Figure E ).

Step 5:

Before you take the needle out of the vial, check the syringe for air bubbles. If bubbles are in the syringe, hold the syringe straight up and tap the side of the syringe until the bubbles float to the top. Push the bubbles out with the plunger and draw insulin back in until you have the correct dose (see Figure F ).

Step 6:

Remove the needle from the vial. Do not let the needle touch anything. You are now ready to inject.

Giving your MERILOG injection with a syringe

• Inject your insulin exactly as your healthcare provider has shown you.
• MERILOG starts acting fast. You should eat a meal within 5 to 10 minutes after you take your dose of MERILOG.

Step 7:

• Choose your injection site: MERILOG is injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs) or upper arms (see Figure G ).
• Do not use the exact same spot for each injection. Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting pits in the skin or thickened skin (lipodystrophy) and skin with lumps (localized cutaneous amyloidosis) 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.
  
  
                           (Figure G)

• Wipe the skin with an alcohol swab to clean the injection site. Let the injection site dry before you inject your dose (see Figure H ).
  
  
        (Figure H)

Step 8:

• Pinch the skin.
• Insert the needle in the way your healthcare provider showed you.
• Release the skin.
• Slowly push in the plunger of the syringe all the way, making sure you have injected all the insulin.
• Leave the needle in the skin for about 10 seconds (see Figure I ).
  
  
        (Figure I)

Step 9:

• Pull the needle straight out of your skin.
• Gently press the injection site for several seconds. Do not rub the area.
• Do not recap the used needle. Recapping the needle can lead to a needle-stick injury.

Disposing of used needles and syringes

• Put your used needles and syringes in a 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 a FDA-cleared sharps 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.

How should I store MERILOG?

Unopened (not in-use) MERILOG vials

• Store unused MERILOG vials in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not freeze MERILOG.
• Keep MERILOG away from direct heat and light.
• If a vial has been frozen or overheated, throw it away.
• Unopened vials can be used until the expiration date on the carton and label if they have been stored in the refrigerator.
• Unopened vials should be thrown away after 28 days if they are stored at room temperature.

After MERILOG vials have been opened (in-use)

• Store in-use (opened) MERILOG vials in a refrigerator between 36°F to 46°F (2°C to 8°C) or at room temperature below 86°F (30°C) for up to 28 days.
• Do not freeze MERILOG.
• Do not expose MERILOG to excessive heat or light.
• If a vial has been frozen, throw it away.
• The MERILOG vial you are using should be thrown away after 28 days, even if it still has insulin left in it.

Manufactured by:

sanofi-aventis U.S. LLC

Morristown, NJ 07960

A SANOFI COMPANY

U.S. License No. 1752

©2025 Sanofi. All rights reserved.

All trademarks mentioned in this document are the property of the Sanofi group.

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

Approved: May 2025

Pharmacokinetics of subcutaneous administration of insulin aspart is presented below.

Patients with hepatic impairment may be at increased risk of hypoglycemia and may require more frequent MERILOG dose adjustment and more frequent blood glucose monitoring [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].

MERILOG is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

The primary activity of insulin, including insulin aspart products is the regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.

Dispense in the original sealed carton with the enclosed Instructions for Use.

Store unused MERILOG in a refrigerator between 2°C to 8°C (36°F to 46°F). Do not freeze MERILOG and do not use MERILOG if it has been frozen. Do not expose MERILOG to excessive heat or light.

Do not withdraw MERILOG into a syringe and store for later use.

Always remove and discard the needle after each injection from the MERILOG SoloStar prefilled pen and store without a needle attached.

The storage conditions are summarized in the following table:

• Individualize the dosage of MERILOG based on the patient's metabolic needs, blood glucose monitoring results and glycemic control goal.
• Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness [see Warnings and Precautions (5.2, 5.3) and Use in Specific Populations (8.6, 8.7)].
• When switching from another insulin to MERILOG, a different dosage of MERILOG may be needed [see Warnings and Precautions (5.2)].
• During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions (5.2)].

• Never share a MERILOG SoloStar prefilled pen between patients, even if the needle is changed (5.1).
• Hyperglycemia or hypoglycemia with changes in insulin regimen: Make changes to a patient's insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring (5.2).
• Hypoglycemia: May be life-threatening. Increase frequency of glucose monitoring with changes to: insulin dosage, concomitantly administered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairments and hypoglycemia unawareness (5.3).
• Medication Errors: Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection (5.4).
• Hypersensitivity reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, may occur. Discontinue MERILOG, treat, and monitor, if indicated (5.5).
• Hypokalemia: May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated (5.6).
• Fluid retention and heart failure with concomitant use of thiazolidinediones (TZDs): Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs (5.7).

See Full Prescribing Information for important preparation, administration, and dosage instructions (2.1, 2.2, 2.3, 2.4, 2.5).

• Subcutaneous injection (2.2):
  • Inject subcutaneously within 5–10 minutes before a meal into the abdominal area, thigh, buttocks or upper arm.
  • Rotate injection sites within the same region from one injection to the next to reduce risk of lipodystrophy and localized cutaneous amyloidosis.
  • Should generally be used in regimens with an intermediate- or long-acting insulin.
• Individualize and adjust the dosage of MERILOG based on the individual's metabolic needs, blood glucose monitoring results and glycemic control goal (2.3).
• Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness (2.3).

Injection: 100 units/mL (U-100) is a clear and colorless solution available as:

• 10 mL multiple-dose vial
• 3 mL single-patient-use MERILOG SoloStar^® prefilled pen

The following adverse reactions have been identified during post-approval use of insulin aspart products. Because these adverse reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Medication errors have been reported in which other insulins have been accidentally substituted for insulin aspart products.

Localized cutaneous amyloidosis at the injection site has occurred with insulin aspart products. Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including insulin aspart products. If hypersensitivity reactions occur, discontinue MERILOG; treat per standard of care and monitor until symptoms and signs resolve [see Adverse Reactions (6)]. MERILOG is contraindicated in patients who have had hypersensitivity reactions to insulin aspart products or any of the excipients in MERILOG [see Contraindications (4)].

Because clinical trials are conducted under widely varying designs, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice. The safety of insulin aspart was evaluated in two treat-to-target trials of 6 months duration, conducted in patients with type 1 diabetes or type 2 diabetes [see Clinical Studies (14)].

The data in Table 1 reflect the exposure of 596 patients with type 1 diabetes to insulin aspart in one clinical trial with a mean exposure duration to insulin aspart of 24 weeks. The mean age was 39 years. Fifty-one percent were male, 94% were Caucasian, 2% were Black and 4% were other races. The mean body mass index (BMI) was 25.6 kg/m². The mean duration of diabetes was 15.7 years and the mean HbA_1c at baseline was 7.9%.

The data in Table 2 reflect the exposure of 91 patients with type 2 diabetes to insulin aspart in one clinical trial with a mean exposure duration to insulin aspart of 24 weeks. The mean age was 57 years. Sixty-three percent were male, 76% were Caucasian, 9% were Black and 15% were other races. The mean BMI was 29.7 kg/m². The mean duration of diabetes was 12.7 years and the mean HbA_1c at baseline was 8.1%.

Common adverse reactions were defined as events that occurred in ≥5%, excluding hypoglycemia, of the population studied. Common adverse events that occurred at the same rate or greater for insulin aspart-treated patients than in comparator-treated patients during clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus (other than hypoglycemia) are listed in Table 1 and Table 2, respectively.

The safety and effectiveness of subcutaneous insulin aspart were compared to regular human insulin in 596 type 1 diabetes adult, 187 pediatric type 1 diabetes, and 91 adult type 2 diabetes patients using NPH as basal insulin (see Tables 3, 4, 5). The reduction in glycated hemoglobin (HbA_1c) was similar to regular human insulin.

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

Accidental mix-ups between insulin products have been reported. To avoid medication errors between MERILOG and other insulins, instruct patients to always check the insulin label before each injection.

Rx only

NDC 0024-5928-05

Merilog™ SoloStar^®

(insulin aspart-szjj) injection

For Single Patient Use Only

100 units/mL (U-100)

For subcutaneous injection only

Do not mix with other insulins

Needles not included

Dispense in this sealed carton

Five 3 mL Prefilled Pens

sanofi

In standard biological assays in mice and rabbits, one unit of insulin aspart has the same glucose-lowering effect as one unit of regular human insulin.

NDC 0024-5927-00

Rx only

Merilog™

(insulin aspart-szjj) injection

100 units/mL (U-100)

For subcutaneous injection only

Use only with a U-100 syringe

One 10 mL multiple-dose vial

sanofi

Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia; increased frequency of blood glucose monitoring is recommended. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended.

• Dosage modification may be needed when MERILOG is used concomitantly with certain drugs [see Drug Interactions (7)].

Do not mix MERILOG with any other insulin.

Standard 2-year carcinogenicity studies in animals have not been performed to evaluate the carcinogenic potential of insulin aspart products. In 52-week studies, Sprague-Dawley rats were dosed subcutaneously with insulin aspart at 10, 50, and 200 units/kg/day (approximately 2, 8, and 32 times the human subcutaneous dose of 1.0 units/kg/day, based on units/body surface area, respectively). At a dose of 200 units/kg/day, insulin aspart increased the incidence of mammary gland tumors in females when compared to untreated controls. The relevance of these findings to humans is unknown.

Insulin aspart was not genotoxic in the following tests: Ames test, mouse lymphoma cell forward gene mutation test, human peripheral blood lymphocyte chromosome aberration test, in vivo micronucleus test in mice, and in ex vivo UDS test in rat liver hepatocytes.

In fertility studies in male and female rats, at subcutaneous doses up to 200 units/kg/day (approximately 32 times the human subcutaneous dose, based on units/body surface area), no direct adverse effects on male and female fertility, or general reproductive performance of animals was observed.

• Always check insulin labels before administration [see Warnings and Precautions (5.4)].
• Inspect MERILOG visually before use. It should appear clear and colorless. Do not use MERILOG if particulate matter or coloration is seen.
• Use MERILOG SoloStar prefilled pen with caution in patients with visual impairment who may rely on audible clicks to dial their dose.

MERILOG SoloStar prefilled pen should never be shared between patients, even if the needle is changed. Patients using MERILOG vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.

Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia [see Warnings and Precautions (5.3)] or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia [see Adverse Reactions (6.1, 6.3)].

Make any changes to a patient's insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.

Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including MERILOG, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.