![MERILOG insulin aspart-szjj 100 [iU]/mL Injection, Solution — NDC 00024-5928-05 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=eee07a52-1102-4d48-9782-26061db175ad&name=eee07a52-1102-4d48-9782-26061db175ad-35.jpg)
MERILOG insulin aspart-szjj 100 [iU]/mL Injection, Solution — NDC 0024-5928-05 (Billing 00024-5928-05)
This is a package of MERILOG insulin aspart-szjj 100 [iU]/mL Injection, Solution from Sanofi-Aventis U.S. LLC, marketed since Feb 2025 and currently FDA-listed; retail pharmacies pay about $8.72 per mL (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 0024-5928-05 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0024 labeler · 5928 product · 05 package
- Package marketed since
- Feb 14, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 0024592805 4
- Medicaid fills, this package
- 162 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 087245
- GCN: 57103
- GPI-14 (Medi-Span): 2710400201D220
- HICL (First Databank): 050283
- AHFS class code: 68:20.08.00
- RxCUI (RxNorm): 2705733
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 8, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Insulin Analog class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 8, 2026
Clinical
- It helps control blood sugar in people with diabetes mellitus. The 70/30 mix is for adults, while other products like NovoLog and Fiasp are mealtime insulins. The mix is not for di...
- NovoLog is injected under the skin within 5 to 10 minutes before a meal. Rotate sites among your belly, thigh, buttocks or upper arm. Follow your prescriber’s plan and your product...
- Low blood sugar. Shakiness, sweating or confusion can be warning signs, though they can be subtle. Check your sugar often and carry fast-acting sugar. Severe lows need emergency he...
- What side effect should I watch for most?
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $8.716 | $130.74 / 15 ml |
| Medicaid paysCMS SDUD · 12 mo | $9.33 | $139.89 / 15 ml |
| Medicare drug plans payPart D · Q2 2026 | $8.56 | $128.44 / 15 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00024-5928-05 You're viewing this Main listing | 5 SYRINGE in 1 BOX / 3 mL in 1 SYRINGE | 2025-02-14 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Merilog 100 [iU]/mL 00024-5927-00 | Sanofi-Aventis | 1 vial | $6.820 | — | Availability likely | save 22% |
| Merilog 100 [iU]/mLthis 00024-5928-05 | Sanofi-Aventis | 5 syringes | $8.716 | — | Availability likely | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Purple Book · refreshed Oct 5, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & biosimilar status
1 biosimilar and 1 interchangeable are FDA-licensed for this reference biologic — see the list below. (Biologics have no small-molecule generics.)
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Feb 14, 2037 |
Is there a biosimilar for MERILOG SOLOSTAR 100 UNIT/ML?
Why do different websites show different biosimilar dates?
Can a biosimilar launch before the last patent expires?
What does “current Purple Book estimate” mean?
What does “FDA listed” mean?
What does a patent or protection date mean here?
Where does this data come from?
- FDA Purple Book · refreshed Oct 5, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Insulin Aspart (rDNA Origin) Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
1.72 mg / 1 mL
UNII GGO4Y809LO
Metacresol is a preservative derived from coal tar or petroleum. It prevents bacterial and fungal growth in liquid medicines, helping keep the product safe and stable during storage.
-
1.5 mg / 1 mL
UNII 339NCG44TV
Phenol is a chemical compound derived from coal tar or petroleum. It serves as a preservative and antimicrobial agent in medicines, helping prevent bacterial and fungal growth to keep the product stable and safe during storage.
-
0.02 mg / 1 mL
UNII 7T1F30V5YH
A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
-
6.8 mg / 1 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
-
0.04 mg / 1 mL
UNII 86Q357L16B
Zinc chloride is a mineral salt used as a buffer and pH regulator in medications. It helps maintain the chemical stability and proper acidity level of the drug formulation.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Sanofi-Aventis U.S. LLC labeler code 00024
- KEVZARA sarilumab 150 mg/1.14mL Injection, Solution NDC 0024-5920-01
- KEVZARA sarilumab 200 mg/1.14mL Injection, Solution NDC 0024-5922-01
- ADMELOG insulin lispro 100 U/mL Injection, Solution NDC 0024-5924-10
- ADMELOG insulin lispro 100 U/mL Injection, Solution NDC 0024-5925-00
- ADMELOG insulin lispro 100 U/mL Injection, Solution NDC 0024-5926-05
- MERILOG insulin aspart-szjj 100 [iU]/mL Injection, Solution NDC 0024-5927-00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE MERILOG is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. MERILOG is rapid acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus ( 1 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION 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 ).
2.1Important Preparation and Administration Instructions 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.
2.2Preparation and Administration Instructions for the Approved Routes of Administration 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.
2.3Dosage Recommendations 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) ] .
2.4Dosage Modifications for Drug Interactions Dosage modification may be needed when MERILOG is used concomitantly with certain drugs [see Drug Interactions (7) ] .
2.5Instructions for Mixing MERILOG with Other Insulins Do not mix MERILOG with any other insulin.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 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 Injection: 100 units/mL (U-100) of insulin aspart-szjj available as: ( 3 ) 10 mL multiple-dose vial 3 mL single-patient-use MERILOG SoloStar ® prefilled pen
⛔ Contraindications ▾
4 CONTRAINDICATIONS 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) ]. During episodes of hypoglycemia ( 4 ). Hypersensitivity to insulin aspart products or any of the excipients in MERILOG.( 4 ).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS 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 ).
5.1Never Share a MERILOG SoloStar Prefilled Pen Between Patients 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.
5.2Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen 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.
5.3Hypoglycemia 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. Risk Factors for Hypoglycemia The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal.
As with all insulins, the glucose lowering effect time course of insulin aspart products may vary in different individuals or at different times in the same individual and depends on many conditions,… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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) ] Adverse reactions observed with insulin aspart products include: hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience 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/m 2 .
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/m 2 . 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. Table 1: Adverse reactions that occurred in ≥5% of Type 1 Diabetes Mellitus Adult Patients treated with insulin aspart and at the same rate or greater on insulin aspart than on comparator Insulin aspart + NPH (%) (n= 596) Regular Human Insulin + NPH (%) (n= 286) Headache 12 10 Injury accidental 11 10 Nausea 7 5 Diarrhea 5 3 Table 2: Adverse reactions that occurred in ≥5% of Type 2 Diabetes Mellitus Adult Patients treated with insulin aspart and at the same rate or greater on insulin aspart than on comparator Insulin aspart + NPH (%) (n= 91) Human Regular Insulin + NPH (%) (n= 91) Hyporeflexia 11 7 Onychomycosis 10 5 Sensory disturbance 9 7 Urinary tract infection 8 7 Chest pain 5 3 Headache 5 3 Skin disorder 5 2 Abdominal pain 5 1 Sinusitis 5 1 Severe Hypoglycemia Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including insulin aspart products [see Warnings and Precautions (5.3) ] .
The rates of reported hypoglycemia depend on the definition of hypoglycemia used, diabetes type, insulin dose, intensity of glucose control, background therapies, and other intrinsic and extrinsic patient factors. For these reasons, comparing rates of hypoglycemia in clinical trials for insulin aspart with the incidence of hypoglycemia for other products may be misleading and also, may not be representative of hypoglycemia rates that will occur in clinical practice. Severe hypoglycemia was defined as hypoglycemia associated with central nervous system symptoms and requiring the intervention of another person or hospitalization.
The incidence of severe hypoglycemia in… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS The table below presents clinically significant drug interactions with MERILOG. Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when MERILOG is concomitantly administered with these drugs.
Drugs That May Decrease the Blood Glucose Lowering Effect of MERILOG Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when MERILOG is concomitantly administered with these drugs.
Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of MERILOG Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when MERILOG is concomitantly administered with these drugs. Drugs That May Blunt Signs and Symptoms of Hypoglycemia Drugs: Beta-blockers, clonidine, guanethidine and reserpine Intervention: Increased frequency of glucose monitoring may be required when MERILOG is concomitantly administered with these drugs. Drugs that may increase the risk of hypoglycemia: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics ( 7 ).
Drugs that may decrease the blood glucose lowering effect: Atypical antipsychotics, corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones ( 7 ). Drugs that may increase or decrease the blood glucose lowering effect: Alcohol, beta-blockers, clonidine, lithium salts, and pentamidine ( 7 ). Drugs that may blunt the signs and symptoms of hypoglycemia: Beta-blockers, clonidine, guanethidine, and reserpine ( 7 ).
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Available information from published randomized controlled trials with insulin aspart products use during the second trimester of pregnancy have not reported an association with insulin aspart products and major birth defects or adverse maternal or fetal outcomes [see Data ] . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations ] . In animal reproduction studies, administration of subcutaneous insulin aspart to pregnant rats and rabbits during the period of organogenesis did not cause adverse developmental effects at exposures 8-times and equal to the human subcutaneous dose of 1 unit/kg/day, respectively.
Pre- and post-implantation losses and visceral/skeletal abnormalities were seen at higher exposures, which are considered secondary to maternal hypoglycemia. These effects were similar to those observed in rats administered regular human insulin [see Data ] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a periconceptual HbA 1c >7% and has been reported to be as high as 20 to 25% in women with a periconceptual HbA 1c >10%. The estimated background risk of miscarriage for the indicated population is unknown. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications.
Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Data Human Data Published data from 5 randomized controlled trials of 441 pregnant women with diabetes mellitus treated with insulin aspart products during the late 2 nd trimester of pregnancy did not identify an association of insulin aspart products with major birth defects or adverse maternal or fetal outcomes. However, these studies cannot definitely establish the absence of any risk because of methodological limitations, including a variable duration of treatment and small size of the majority of the trials.
Animal Data Fertility, embryo-fetal and pre- and postnatal development studies have been performed with insulin aspart and regular human insulin in rats and rabbits. In a combined fertility and embryo-fetal development study in rats, insulin aspart was administered before mating, during mating, and throughout pregnancy. Further, in a pre- and postnatal development study insulin aspart was given throughout pregnancy and during lactation to rats.
In an embryo-fetal development study insulin aspart was given to female rabbits during organogenesis. The effects of insulin aspart did not differ from those observed with subcutaneous regular human insulin. Insulin aspart, like human insulin, caused pre- and post-implantation losses and visceral/skeletal abnormalities in rats at a dose of 200 units/kg/day (approximately 32 times the human subcutaneous dose of 1 unit/kg/day, based on human exposure equivalents) and in rabbits at a dose of 10 units/kg/day (approximately three times the human subcutaneous dose of 1 unit/kg/day, based on human exposure equivalents).
No significant effects were observed in rats at a dose of 50 units/kg/day and in rabbits at a dose of 3 units/kg/day. These doses are approximately 8 times the human subcutaneous dose of 1 unit/kg/day for rats and equal to the human subcutaneous dose of 1 unit/kg/day for rabbits, based on human exposure equivalents. The effects are considered secondary to maternal hypoglycemia.
8.2Lactation Risk Summary There are no data on the presence of insulin aspart products in human milk, the effects on the breastfed infant, or the effect… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available information from published randomized controlled trials with insulin aspart products use during the second trimester of pregnancy have not reported an association with insulin aspart products and major birth defects or adverse maternal or fetal outcomes [see Data ] . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations ] . In animal reproduction studies, administration of subcutaneous insulin aspart to pregnant rats and rabbits during the period of organogenesis did not cause adverse developmental effects at exposures 8-times and equal to the human subcutaneous dose of 1 unit/kg/day, respectively.
Pre- and post-implantation losses and visceral/skeletal abnormalities were seen at higher exposures, which are considered secondary to maternal hypoglycemia. These effects were similar to those observed in rats administered regular human insulin [see Data ] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a periconceptual HbA 1c >7% and has been reported to be as high as 20 to 25% in women with a periconceptual HbA 1c >10%. The estimated background risk of miscarriage for the indicated population is unknown. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications.
Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Data Human Data Published data from 5 randomized controlled trials of 441 pregnant women with diabetes mellitus treated with insulin aspart products during the late 2 nd trimester of pregnancy did not identify an association of insulin aspart products with major birth defects or adverse maternal or fetal outcomes. However, these studies cannot definitely establish the absence of any risk because of methodological limitations, including a variable duration of treatment and small size of the majority of the trials.
Animal Data Fertility, embryo-fetal and pre- and postnatal development studies have been performed with insulin aspart and regular human insulin in rats and rabbits. In a combined fertility and embryo-fetal development study in rats, insulin aspart was administered before mating, during mating, and throughout pregnancy. Further, in a pre- and postnatal development study insulin aspart was given throughout pregnancy and during lactation to rats.
In an embryo-fetal development study insulin aspart was given to female rabbits during organogenesis. The effects of insulin aspart did not differ from those observed with subcutaneous regular human insulin. Insulin aspart, like human insulin, caused pre- and post-implantation losses and visceral/skeletal abnormalities in rats at a dose of 200 units/kg/day (approximately 32 times the human subcutaneous dose of 1 unit/kg/day, based on human exposure equivalents) and in rabbits at a dose of 10 units/kg/day (approximately three times the human subcutaneous dose of 1 unit/kg/day, based on human exposure equivalents).
No significant effects were observed in rats at a dose of 50 units/kg/day and in rabbits at a dose of 3 units/kg/day. These doses are approximately 8 times the human subcutaneous dose of 1 unit/kg/day for rats and equal to the human subcutaneous dose of 1 unit/kg/day for rabbits, based on human exposure equivalents. The effects are considered secondary to maternal hypoglycemia.
🧒 Pediatric Use ▾
8.4Pediatric Use 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) ] .
🧓 Geriatric Use ▾
8.5Geriatric Use 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.
🆘 Overdosage ▾
10 OVERDOSAGE 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action 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.
12.2Pharmacodynamics Pharmacodynamics of Insulin Aspart After Subcutaneous Administration The pharmacodynamic profile of insulin aspart given subcutaneously in 22 patients with type 1 diabetes is shown in Figure 1. The maximum glucose-lowering effect of insulin aspart occurred between 1 and 3 hours after subcutaneous injection (0.15 units/kg). The duration of action for insulin aspart is 3 to 5 hours.
The time course of action of insulin and insulin analogs such as insulin aspart products may vary considerably in different individuals or within the same individual. The parameters of insulin aspart activity (time of onset, peak time and duration) as designated in Figure 1 should be considered only as general guidelines. The rate of insulin absorption and onset of activity is affected by the site of injection, exercise, and other variables [see Warnings and Precautions (5.3) ] .
Figure 1. Serial mean serum glucose collected up to 6 hours following a single 0.15 units/kg pre-meal dose of insulin aspart (solid curve) or regular human insulin (hatched curve) injected immediately before a meal in 22 patients with type 1 diabetes. Figure 1
12.3Pharmacokinetics Pharmacokinetics of subcutaneous administration of insulin aspart is presented below. Absorption and Bioavailability In studies in healthy volunteers (total n=107) and patients with type 1 diabetes (total n=40), the median time to maximum concentration of insulin aspart in these trials was 40 to 50 minutes versus 80 to 120 minutes, for regular human insulin respectively. The relative bioavailability of insulin aspart (0.15 units/kg) compared to regular human insulin indicates that the two insulins are absorbed to a similar extent.
In a clinical trial in patients with type 1 diabetes, insulin aspart and regular human insulin, both administered subcutaneously at a dose of 0.15 units/kg body weight, reached mean maximum concentrations of 82 and 36 mU/L, respectively. Distribution Insulin aspart has a low binding affinity to plasma proteins (<10%), similar to that seen with regular human insulin. Figure 2.
Serial mean serum free insulin concentration collected up to 6 hours following a single 0.15 units/kg pre-meal dose of insulin aspart (solid curve) or regular human insulin (hatched curve) injected immediately before a meal in 22 patients with type 1 diabetes. Figure 2 Metabolism and Elimination After subcutaneous administration in normal male volunteers (n=24), insulin aspart was eliminated with an average apparent half-life of 81 minutes. Specific Populations Pediatric Patients : The pharmacokinetic and pharmacodynamic properties of insulin aspart and regular human insulin were evaluated in a single dose study in 18 pediatric patients with type 1 diabetes in 2 age groups: 6–12 years, n=9 and 13–17 years (Tanner grade ≥2), n=9.
The relative differences in pharmacokinetics and pharmacodynamics in the pediatric patients with type 1 diabetes in both age groups between insulin aspart and regular human insulin were similar to those in healthy adult subjects and adults with type 1 diabetes. Geriatric Patients : The pharmacokinetic and pharmacodynamic properties of insulin aspart and regular human insulin were investigated in a single dose study in 18 subjects with type 2 diabetes who were ≥65 years of age. The relative differences in pharmacokinetics and pharmacodynamics in geriatric patients with type 2 diabetes between insulin aspart and regular human insulin were similar to those in younger adults.
Male and Female Patients : In healthy volunteers given a single subcutaneous dose of… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied MERILOG (insulin aspart-szjj) injection 100 units/mL (U-100) is available as a clear and colorless solution in: Dosage Unit NDC # One 10 mL multiple-dose vial per carton NDC 0024-5927-00 Five 3 mL single-patient-use SoloStar prefilled pens per carton NDC 0024-5928-05 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 ® ).
16.2Recommended Storage 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: Table 6. Storage Conditions for Vial and SoloStar Prefilled Pen MERILOG presentation Not in-use (unopened) Room Temperature (up to 30°C [86°F]) Not in-use (unopened) Refrigerated (2°C to 8°C [36°F to 46°F]) In-use (opened) Room Temperature (up to 30°C [86°F]) 10 mL multiple-dose vial 28 days Until expiration date 28 days (refrigerated/room temperature) 3 mL single-patient-use SoloStar prefilled pen 28 days Until expiration date 28 days (Do not refrigerate)
📦 Storage and Handling ▾
16.2Recommended Storage 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: Table 6. Storage Conditions for Vial and SoloStar Prefilled Pen MERILOG presentation Not in-use (unopened) Room Temperature (up to 30°C [86°F]) Not in-use (unopened) Refrigerated (2°C to 8°C [36°F to 46°F]) In-use (opened) Room Temperature (up to 30°C [86°F]) 10 mL multiple-dose vial 28 days Until expiration date 28 days (refrigerated/room temperature) 3 mL single-patient-use SoloStar prefilled pen 28 days Until expiration date 28 days (Do not refrigerate)
📋 Description ▾
11 DESCRIPTION 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.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Never Share a MERILOG SoloStar Prefilled Pen between Patients Advise patients that they must never share MERILOG SoloStar prefilled pen device with another person even if the needle is changed, because doing so carries a risk for transmission of blood-borne pathogens. Advise patients using MERILOG vials not to share needles or syringes with another person.
Sharing poses a risk for transmission of blood-borne pathogens [see Warnings and Precautions (5.1) ] . Hyperglycemia or Hypoglycemia Inform patients that hypoglycemia is the most common adverse reaction with insulin. Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of MERILOG therapy.
Instruct patients on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals. Instruct patients on the management of hypoglycemia [see Warnings and Precautions (5.3) ] . Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia.
Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery. Advise patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia and that changes in insulin regimen should be made under close medical supervision [see Warnings and Precautions (5.2) ] . Hypoglycemia with Medication Errors Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products [see Warnings and Precautions (5.4) ] .
Hypersensitivity Reactions Advise patients that hypersensitivity reactions have occurred with insulin aspart products. Inform patients of the symptoms of hypersensitivity reactions [see Warnings and Precautions (5.5) ].
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Pharmacokinetics of subcutaneous administration of insulin aspart is presented below. Absorption and Bioavailability In studies in healthy volunteers (total n=107) and patients with type 1 diabetes (total n=40), the median time to maximum concentration of insulin aspart in these trials was 40 to 50 minutes versus 80 to 120 minutes, for regular human insulin respectively. The relative bioavailability of insulin aspart (0.15 units/kg) compared to regular human insulin indicates that the two insulins are absorbed to a similar extent.
In a clinical trial in patients with type 1 diabetes, insulin aspart and regular human insulin, both administered subcutaneously at a dose of 0.15 units/kg body weight, reached mean maximum concentrations of 82 and 36 mU/L, respectively. Distribution Insulin aspart has a low binding affinity to plasma proteins (<10%), similar to that seen with regular human insulin. Figure 2.
Serial mean serum free insulin concentration collected up to 6 hours following a single 0.15 units/kg pre-meal dose of insulin aspart (solid curve) or regular human insulin (hatched curve) injected immediately before a meal in 22 patients with type 1 diabetes. Figure 2 Metabolism and Elimination After subcutaneous administration in normal male volunteers (n=24), insulin aspart was eliminated with an average apparent half-life of 81 minutes. Specific Populations Pediatric Patients : The pharmacokinetic and pharmacodynamic properties of insulin aspart and regular human insulin were evaluated in a single dose study in 18 pediatric patients with type 1 diabetes in 2 age groups: 6–12 years, n=9 and 13–17 years (Tanner grade ≥2), n=9.
The relative differences in pharmacokinetics and pharmacodynamics in the pediatric patients with type 1 diabetes in both age groups between insulin aspart and regular human insulin were similar to those in healthy adult subjects and adults with type 1 diabetes. Geriatric Patients : The pharmacokinetic and pharmacodynamic properties of insulin aspart and regular human insulin were investigated in a single dose study in 18 subjects with type 2 diabetes who were ≥65 years of age. The relative differences in pharmacokinetics and pharmacodynamics in geriatric patients with type 2 diabetes between insulin aspart and regular human insulin were similar to those in younger adults.
Male and Female Patients : In healthy volunteers given a single subcutaneous dose of insulin aspart 0.06 units/kg, no difference in insulin aspart levels was seen between males and females based on comparison of AUC (0–10h) or C max . Obese Patients : A single subcutaneous dose of 0.1 units/kg insulin aspart was administered in a study of 23 patients with type 1 diabetes and a wide range of body mass index (BMI, 22–39 kg/m 2 ). The pharmacokinetic parameters, AUC and C max , of insulin aspart were generally unaffected by BMI in the different groups – BMI 19–23 kg/m 2 (n=4); BMI 23–27 kg/m 2 (n=7); BMI 27–32 kg/m 2 (n=6) and BMI >32 kg/m 2 (n=6).
Clearance of insulin aspart was reduced by 28% in patients with BMI >32 kg/m 2 compared to patients with BMI <23 kg/m 2 . Patients with Renal Impairment : A single subcutaneous dose of 0.08 units/kg insulin aspart was administered in a study to subjects with either normal renal function (n=6) creatinine clearance (CLcr) (>80 ml/min) or mild (n=7; CLcr=50–80 ml/min), moderate (n=3; CLcr=30–50 ml/min) or severe (but not requiring hemodialysis) (n=2; CLcr = <30 ml/min) renal impairment. In this study, there was no apparent effect of creatinine clearance values on AUC and C max of insulin aspart.
Patients with Hepatic Impairment : A single subcutaneous dose of 0.06 units/kg insulin aspart was administered in an open-label, single-dose study of 24 subjects (n=6/group) with different degree of hepatic impairment (mild, moderate and severe) having Child-Pugh Scores ranging from 0 (healthy volunteers) to 12 (severe hepatic impairment). In this study, there was no correlation betwee… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Pharmacodynamics of Insulin Aspart After Subcutaneous Administration The pharmacodynamic profile of insulin aspart given subcutaneously in 22 patients with type 1 diabetes is shown in Figure 1. The maximum glucose-lowering effect of insulin aspart occurred between 1 and 3 hours after subcutaneous injection (0.15 units/kg). The duration of action for insulin aspart is 3 to 5 hours.
The time course of action of insulin and insulin analogs such as insulin aspart products may vary considerably in different individuals or within the same individual. The parameters of insulin aspart activity (time of onset, peak time and duration) as designated in Figure 1 should be considered only as general guidelines. The rate of insulin absorption and onset of activity is affected by the site of injection, exercise, and other variables [see Warnings and Precautions (5.3) ] .
Figure 1. Serial mean serum glucose collected up to 6 hours following a single 0.15 units/kg pre-meal dose of insulin aspart (solid curve) or regular human insulin (hatched curve) injected immediately before a meal in 22 patients with type 1 diabetes. Figure 1
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Overview of Clinical Studies 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.
14.2Clinical Studies in Adult and Pediatric Patients with Type 1 Diabetes with Subcutaneous Injections Type 1 Diabetes - Adults (see Table 3 ) Two 24-week, open-label, active-controlled studies were conducted to compare the safety and efficacy of insulin aspart to regular human insulin injection in adult patients with type 1 diabetes. Because the two study designs and results were similar, data are shown for only one study (see Table 3 ). The mean age of the trial population was 39 years and mean duration of diabetes was 15.7 years.
Fifty-one percent were male. Ninety-four percent were Caucasian, 2% were Black and 4% were Other. The mean BMI was approximately 25.6 kg/m 2 .
Insulin aspart was administered by subcutaneous injection immediately prior to meals and regular human insulin was administered by subcutaneous injection 30 minutes before meals. NPH insulin was administered as the basal insulin in either single or divided daily doses. Changes in HbA 1c were comparable for the two treatment regimens in this study (Table 3).
Table 3. Type 1 Diabetes Mellitus – Adult (insulin aspart plus NPH insulin vs. regular human insulin plus NPH insulin) Insulin aspart + NPH (n=596) Regular Human Insulin + NPH (n=286) Baseline HbA 1c (%) Values are Mean ± SD 7.9 ± 1.1 8.0 ±
1.2Change from Baseline HbA 1c (%) -0.1 ± 0.8 0.0 ±
0.8Treatment Difference in HbA 1c , Mean (95% confidence interval) -0.2 (-0.3, -0.1) Type 1 Diabetes – Pediatric (see Table 4 ) The efficacy of insulin aspart to improve glycemic control in pediatric patients with type 1 diabetes mellitus is based on an adequate and well-controlled trial of regular human insulin in pediatric patients with type 1 diabetes mellitus (Table 4). This 24-week, parallel-group study of pediatric patients with type 1 diabetes (n=283), aged 6 to 18 years, compared two subcutaneous multiple-dose treatment regimens: insulin aspart (n=187) or regular human insulin (n=96).
NPH insulin was administered as the basal insulin. Similar effects on HbA 1c were observed in both treatment groups (Table 4). Subcutaneous administration of insulin aspart and regular human insulin have also been compared in pediatric patients with type 1 diabetes (n=26) aged 2 to 6 years with similar effects on HbA 1c .
Table 4. Pediatric Subcutaneous Administration of Insulin Aspart in Type 1 Diabetes (24 weeks; n=283) Insulin aspart + NPH (n=187) Regular Human Insulin + NPH (n=96) Baseline HbA 1c (%) Values are Mean ± SD 8.3 ± 1.2 8.3 ±
1.3Change from Baseline HbA 1c (%) 0.1 ± 1.0 0.1 ±
1.1Treatment Difference in HbA 1c , Mean (95% confidence interval) -0.2 (-0.5, 0.1)
14.3Clinical Studies in Adults with Type 2 Diabetes with Subcutaneous Injections Type 2 Diabetes - Adults (see Table 5 ) One six-month, open-label, active-controlled study was conducted to compare the safety and efficacy of insulin aspart to regular human insulin in patients with type 2 diabetes (Table 5). The mean age of the trial population was 56.6 years and mean duration of diabetes was 12.7 years. Sixty-three percent were male.
Seventy-six percent were Caucasian, 9% were Black and 15% were Other. The mean BMI was approximately 29.7 kg/m 2 . Insulin aspart was administered by subcutaneous injection immediately prior to meals and regular human insulin was administered by subcutaneous injection 30 minutes before meals.
NPH insulin was administered as the basal insulin in either single or divided daily doses. Changes in HbA 1c were comparable for the two treatment regimens. Table 5.
Subcutaneous Insulin Aspart Administration in Type 2 Diabetes (6 months; n=176) Insulin asp… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility 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.
13.2Animal Toxicology and/or Pharmacology 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.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility 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.
📄 Patient Package Insert ▾
PATIENT INFORMATION MERILOG™ [mer-ih-lawg] (insulin aspart-szjj) injection, for subcutaneous use 100 units/mL (U-100) This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: May 2025 Do not share your MERILOG SoloStar prefilled pen 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. What is MERILOG? MERILOG is a man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus.
Who should not take MERILOG? Do not take MERILOG if you: are having an episode of low blood sugar (hypoglycemia). have an allergy to insulin aspart products or any of the ingredients in MERILOG. Before taking MERILOG, tell your healthcare provider about all your medical conditions including, if you are: pregnant, planning to become pregnant, or are breastfeeding. taking new prescription or over-the-counter medicines, vitamins, or herbal supplements.
Before you start taking MERILOG, talk to your healthcare provider about low blood sugar and how to manage it. How should I take MERILOG? Read the Instructions for Use that come with your MERILOG.
Take MERILOG exactly as your healthcare provider tells you to. MERILOG starts acting fast. You should eat a meal within 5 to 10 minutes after you take your dose of MERILOG.
Know the type and strength of insulin you take. Do not change the type of insulin you take unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you take different types of insulin.
Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels. Do not reuse or share your needles with other people.
You may give other people a serious infection or get a serious infection from them. MERILOG can be injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs (thighs), or upper arms. Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting pits in skin or thickened skin (lipodystrophy) and skin with lumps (localized cutaneous amyloidosis) at the injection sites.
Do not use the exact same spot for each injection. 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.
What should I avoid while taking MERILOG? While taking MERILOG do not: Drive or operate heavy machinery, until you know how MERILOG affects you. Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.
What are the possible side effects of MERILOG? MERILOG can cause serious side effects that can lead to death, including: Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include: dizziness or light-headedness sweating confusion fast heart beat blurred vision slurred speech shakiness anxiety, irritability, or mood changes hunger headache Your insulin dose may need to change because of: change in level of physical activity or exercise weight gain or loss increased stress illness change in diet Other common side effects of MERILOG may include: low potassium in your blood (hypokalemia), reactions at the injection site, itching, rash, serious allergic reactions (whole body reactions), skin thickening or pits at the injection site (lipodystrophy), weight gain, and swelling of your hands and feet.
Get emergency medical help if you have: trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion. These are not all the possible side effects of MERILOG. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088. General information about the safe and effective use of MERILOG. Medicines are… [Excerpted — this section continues on DailyMed.]
📖 Instructions for Use ▾
INSTRUCTIONS FOR USE MERILOG™ [mer-ih-lawg] (insulin aspart-szjj) injection, for subcutaneous use 10 mL multiple-dose vial: 100 units/mL (U-100) 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 ). ( 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 ). ( 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 ).
( Figure C ) ( 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 ). ( 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 ). ( 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.
( Figur… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton 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 PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton
PRINCIPAL DISPLAY PANEL - 3 mL Pen Carton 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 PRINCIPAL DISPLAY PANEL - 3 mL Pen Carton