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Insulin Glargine 100 [iU]/mL Injection, Solution
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Insulin Analog class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Insulin glargine products are used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood). Insulin glargine products are also used to treat people with type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood) who need insulin to control their diabetes. In people with type 1 diabetes, insulin glargine products must be used with another type of insulin (a short-acting insulin). In people with type 2 diabetes, insulin glargine pr...
Read the full MedlinePlus article ↗- Insulin glargine is a long-acting insulin — it's designed to provide a slow, steady background level of insulin over the course of the day, rather than a quick spike like short-act...
- What exactly is insulin glargine and why did my doctor prescribe it instead of regular insulin?
- You can take insulin glargine at any time of day that works for your routine — morning, evening, whenever. The key is to take it at the same time every single day. Consistency help...
- Does it matter what time of day I take my injection?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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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.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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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.
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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.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 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 | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $3.99 | $11.97 / 3 ml |
| Medicare drug plans payPart D · Q2 2026 | $5.97 | $17.90 / 3 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Insulin Glargine 100 [iU]/mL 83257-0014-11 | Biocon | 1 vial | $6.086 | — | Availability likely | — |
| Semglee 100 [iU]/mL 83257-0011-11 | Biocon | 1 vial | $25.978 | — | Availability likely | — |
| Insulin Glargine 100 [iU]/mL 72572-0422-01 | Civica, | 1 syringe | — | — | FDA listed | — |
| Insulin Glargine 100 [iU]/mL 72572-0424-01 | Civica, | 1 syringe | — | — | FDA listed | — |
| Semglee 100 [iU]/mL 83257-0012-31 | Biocon | 1 syringe | — | — | FDA listed | — |
| Insulin Glargine 100 [iU]/mLthis 83257-0015-31 | Biocon | 1 syringe | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & biosimilar status
1 interchangeable is 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 | Jul 28, 2033 |
Is there a biosimilar for INSULIN GLARGINE-YFGN U100 PEN?
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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 83257-0015-31 You're viewing this | 1 SYRINGE in 1 CARTON (83257-015-31) / 3 mL in 1 SYRINGE | — | — | 2023-07-28 | Active |
| 83257-0015-32 | 5 SYRINGE in 1 CARTON (83257-015-32) / 3 mL in 1 SYRINGE | $5.93 / mL | $88.88 | 2023-07-28 | Active |
Pack size FAQ
What quantity is in NDC 83257-0015-31?
What NDC number is used to bill for this package of Insulin Glargine 100 [iU]/mL Injection, Solution?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
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Is this package still being marketed?
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Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Insulin Glargine-yfgn is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use Insulin Glargine-yfgn is not recommended for the treatment of diabetic ketoacidosis. Insulin Glargine-yfgn is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
( 1 ) Limitations of Use Not recommended for the treatment of diabetic ketoacidosis. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Individualize dosage based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, and prior insulin use. ( 2.2 ) • Administer subcutaneously into the abdominal area, thigh, or deltoid once daily at any time of day, but at the same time every day. ( 2.1 ) • Do not dilute or mix with any other insulin or solution.
( 2.1 ) • Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.1 ) • See Full Prescribing Information for the recommended starting dosage in patients with type 2 diabetes (2.3) and how to change to Insulin Glargine-yfgn from other insulins. ( 2.4 ) • Closely monitor glucose when switching to Insulin Glargine-yfgn and during initial weeks thereafter.
( 2.4 )
2.1Important Administration Instructions • Always check insulin labels before administration. This product is SEMGLEE (insulin glargine-yfgn) [see Warnings and Precautions (5.4) ]. • Visually inspect Insulin Glargine-yfgn vials and prefilled pens for particulate matter and discoloration prior to administration. Only use if the solution is clear and colorless with no visible particles. • Administer Insulin Glargine-yfgn subcutaneously into the abdominal area, thigh, or deltoid, and 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) ] . • During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions (5.2) ] . • Do not administer intravenously or via an insulin pump. • Do not dilute or mix Insulin Glargine-yfgn with any other insulin or solution. • The Insulin Glargine-yfgn prefilled pen dials in 1-unit increments. • Use the Insulin Glargine-yfgn prefilled pen with caution in patients with visual impairment who may rely on audible clicks to dial their dose.
2.2General Dosing Instructions • Administer Insulin Glargine-yfgn subcutaneously once daily at any time of day but at the same time every day. • Individualize and adjust the dosage of Insulin Glargine-yfgn 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), during acute illness, or changes in renal or hepatic function. Dosage adjustments should only be made under medical supervision with appropriate glucose monitoring [see Warnings and Precautions (5.2) ] . • In patients with type 1 diabetes, Insulin Glargine-yfgn must be used concomitantly with short-acting insulin.
2.3Initiation of Insulin Glargine-yfgn Therapy Recommended Starting Dosage in Patients with Type 1 Diabetes The recommended starting dosage of Insulin Glargine-yfgn in patients with type 1 diabetes is approximately one-third of the total daily insulin requirements. Use short-acting, premeal insulin to satisfy the remainder of the daily insulin requirements. Recommended Starting Dosage in Patients with Type 2 Diabetes The recommended starting dosage of Insulin Glargine-yfgn in patients with type 2 diabetes who are not currently treated with insulin is 0.2 units/kg or up to 10 units once daily.
2.4Switching to Insulin Glargine-yfgn from Other Insulin Therapies Dosage adjustments are recommended to lower the risk of hypoglycemia when switching patients to Insulin Glargine-yfgn from other insulin therapies [see Warnings and Precautions (5.3) ] . When switching from: • Once-daily insulin glargine 300 units/mL to once-daily Insulin Glargine-yfgn (100 units/mL), the recommended starting Insulin Glargine-yfgn dosage is 80% of the insulin glargine, 300 units/mL dosage that is being discontinued. • Once-daily NPH insulin to once-daily Insulin Glargine-yfgn, the recomm…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 100 units/mL (U-100) a clear and colorless solution available as: • 10 mL multiple dose vial • 3 mL single-patient-use prefilled pen Injection: 100 units/mL (U-100) available as: • 10 mL multiple-dose vial ( 3 ) • 3 mL single-patient-use prefilled pen ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Insulin Glargine-yfgn is contraindicated: • During episodes of hypoglycemia [see Warnings and Precautions (5.3) ] • In patients with hypersensitivity to insulin glargine products or any of the excipients in Insulin Glargine-yfgn [see Warnings and Precautions (5.5) ] • During episodes of hypoglycemia ( 4 ) • Hypersensitivity to insulin glargine products or any excipient in Insulin Glargine-yfgn ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Never share an Insulin Glargine-yfgn prefilled pen, insulin syringe, or needle 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, concomitant drugs, meal pattern, physical activity; and in patients with renal or hepatic impairment and hypoglycemia unawareness. ( 5.3 ) • Hypoglycemia due to 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, can occur. Discontinue Insulin Glargine-yfgn. Monitor and treat 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 of TZD if heart failure occurs.
( 5.7 )
5.1Never Share an Insulin Glargine-yfgn Prefilled Pen, Insulin Syringe, or Needle Between Patients Insulin Glargine-yfgn prefilled pens must never be shared between patients, even if the needle is changed. Patients using Insulin Glargine-yfgn vials must never re-use or 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 unaffected area) has been reported to result in hypoglycemia [see Adverse Reactions (6) ] .
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 oral and antidiabetic products may be needed.
5.3Hypoglycemia Hypoglycemia is the most common adverse reaction associated with insulins, including insulin glargine products. Severe hypoglycemia can cause seizures, may be life-threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place the patient 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 patient and change over time in the same patient. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic neuropathy, using drugs that block the sympathetic nervous system (e.g., beta-blockers) [see Drug Interactions (7) ] , or who experience recurrent hypoglycemia. The long-acting effect of insulin glargine products may delay recovery from 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 cours…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere: Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen [see Warnings and Precautions (5.2) ] 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 commonly associated with insulin glargine products include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Biocon Biologics at 1-833-986-1468 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice. The data in Table 1 reflect the exposure of 2,327 patients with type 1 diabetes to insulin glargine or NPH in Studies A, B, C, and D [see Clinical Studies (14.2) ] . The type 1 diabetes population had the following characteristics: the mean age was 39 years.
54% were male, and the mean body mass index (BMI) was
25.1Kg/m2. Ninety-seven percent were White, 2% were Black or African American and less than 1% were Asian. Approximately 3% of the patients in studies B and C were Hispanic.
The data in Table 2 reflect the exposure of 1,563 patients with type 2 diabetes to insulin glargine or NPH in Studies E, F, and G [see Clinical Studies (14.3) ] . The type 2 diabetes population had the following characteristics: the mean age was 59 years. 58% were male, and mean BMI was 29.2 kg/m 2 .
Eighty-seven percent were White, 8% were Black or African American and 3% were Asian. Approximately 9% of patients in Study F were Hispanic. The frequencies of adverse reactions during insulin glargine clinical studies in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below (Tables 1, 2, 3, and 4).
Table 1: Adverse Reactions Occurring ≥ 5% in Pooled Clinical Studies up to 28 Weeks Duration in Adults with Type 1 Diabetes Insulin Glargine, % (n = 1,257) NPH, % (n = 1,070) Upper respiratory tract infection 22.4
23.1Infection Body system not specified 9.4
10.3Accidental injury 5.7
6.4Headache 5.5
4.7Table 2: Adverse Reactions Occurring ≥ 5% in Pooled Clinical Studies up to 1 Year Duration in Adults with Type 2 Diabetes Insulin Glargine, % (n = 849) NPH, % (n = 714) Upper respiratory tract infection 11.4
13.3Infection Body system not specified 10.4
11.6Retinal vascular disorder 5.8
7.4Table 3: Adverse Reactions Occurring ≥ 10% in a 5-Year Study of Adults with Type 2 Diabetes Insulin Glargine, % (n = 514) NPH, % (n = 503) Upper respiratory tract infection 29.0
33.6Edema peripheral 20.0
22.7Hypertension 19.6
18.9Influenza 18.7
19.5Sinusitis 18.5
17.9Cataract 18.1
15.9Bronchitis 15.2
14.1Arthralgia 14.2
16.1Pain in extremity 13.0
13.1Back pain 12.8
12.3Cough 12.1
7.4Urinary tract infection 10.7
10.1Diarrhea 10.7
10.3Depression 10.5
9.7Headache 10.3
9.3Table 4: Adverse Reactions Occurring ≥ 5% in a 28-Week Clinical Study in Pediatric Patients with Type 1 Diabetes Insulin Glargine, % (n = 174) NPH, % (n = 175) Infection Body system not specified 13.8
17.7Upper respiratory tract infection 13.8
16.0Pharyngitis 7.5
8.6Rhinitis 5.2
5.1Severe Hypoglycemia Hypoglycemia was the most commonly observed adverse reaction in patients treated with insulin glargine. Tables 5, 6, and 7 summarize the incidence of severe hypoglycemia in the insulin glargine clinical studies. Severe symptomatic hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose below 50 mg/dL (≤ 56 mg/dL in t…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 8 includes clinically significant drug interactions with Insulin Glargine-yfgn. Table 8: Clinically Significant Drug Interactions with Insulin Glargine-yfgn 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 analogs (e.g., octreotide), sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors.
Intervention: Dosage reductions and increased frequency of glucose monitoring may be required when Insulin Glargine-yfgn is coadministered with these drugs. Drugs that May Decrease the Blood Glucose Lowering Effect of Insulin Glargine-yfgn 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: Dosage increases and increased frequency of glucose monitoring may be required when Insulin Glargine-yfgn is coadministered with these drugs. Drugs that May Increase or Decrease the Blood Glucose Lowering Effect of Insulin Glargine-yfgn Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
Intervention: Dosage adjustment and increased frequency of glucose monitoring may be required when Insulin Glargine-yfgn is coadministered 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 Insulin Glargine-yfgn is coadministered with these drugs. • Drugs that Affect Glucose Metabolism : Adjustment of insulin dosage may be needed.
( 7 ) • Antiadrenergic Drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine): Signs and symptoms of hypoglycemia may be reduced or absent. ( 7 ) * Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of Insulin Glargine -yfgn has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Published studies with use of insulin glargine products during pregnancy have not reported a clear association with insulin glargine products and adverse developmental outcomes (see Data). There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations). Rats and rabbits were exposed to insulin glargine in animal reproduction studies during organogenesis, respectively 50 times and 10 times the human subcutaneous dosage of 0.2 units/kg/day.
Overall, the effects of insulin glargine did not generally differ from those observed with 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 pregestational diabetes with a peri-conceptional HbA1c >7 and has been reported to be as high as 20% to 25% in women with a peri-conceptional HbA1c >10.
The estimated background risk of miscarriage for the indicated population is unknown. Clinical Considerations Disease-Associated Maternal and/or Embryo-fetal Risk Hypoglycemia and hyperglycemia occur more frequently during pregnancy in patients with pre-gestational diabetes. 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 do not report a clear association with insulin glargine products and major birth defects, miscarriage, or adverse maternal or fetal outcomes when insulin glargine is used during pregnancy. However, these studies cannot definitely establish the absence of any risk because of methodological limitations including small sample size and some lacking comparator groups.
Animal Data Subcutaneous reproduction and teratology studies have been performed with insulin glargine and regular human insulin in rats and Himalayan rabbits. Insulin glargine was given to female rats before mating, during mating, and throughout pregnancy at doses up to 0.36 mg/kg/day, which is approximately 50 times the recommended human subcutaneous starting dosage of 0.2 units/kg/day (0.007 mg/kg/day), on a mg/kg basis. In rabbits, doses of 0.072 mg/kg/day, which is approximately 10 times the recommended human subcutaneous starting dosage of 0.2 units/kg/day on a mg/kg basis, were administered during organogenesis.
The effects of insulin glargine did not generally differ from those observed with regular human insulin in rats or rabbits. However, in rabbits, five fetuses from two litters of the high-dose group exhibited dilation of the cerebral ventricles. Fertility and early embryonic development appeared normal.
8.2Lactation Risk Summary There are either no or only limited data on the presence of insulin glargine products in human milk, the effects on breastfed infant, or the effects on milk production. Endogenous insulin is present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Insulin Glargine-yfgn, and any potential adverse effects on the breastfed child from Insulin Glargine-yfgn or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of Insulin Glargine - yfgn to improve glycemic control in pediatric patients with diabetes mellitus have been established. Use of Insulin Glargine for this indication is supported by Insulin Glargine - yfgn’s approval as a biosimilar to insulin glargine and evidence from an adequate and well-controlled study (Study D) in 174 insulin glargine-treated pediatric patients aged 6 to 15 years with type 1 diabetes mellitus, and from adequate…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Published studies with use of insulin glargine products during pregnancy have not reported a clear association with insulin glargine products and adverse developmental outcomes (see Data). There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations). Rats and rabbits were exposed to insulin glargine in animal reproduction studies during organogenesis, respectively 50 times and 10 times the human subcutaneous dosage of 0.2 units/kg/day.
Overall, the effects of insulin glargine did not generally differ from those observed with 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 pregestational diabetes with a peri-conceptional HbA1c >7 and has been reported to be as high as 20% to 25% in women with a peri-conceptional HbA1c >10.
The estimated background risk of miscarriage for the indicated population is unknown. Clinical Considerations Disease-Associated Maternal and/or Embryo-fetal Risk Hypoglycemia and hyperglycemia occur more frequently during pregnancy in patients with pre-gestational diabetes. 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 do not report a clear association with insulin glargine products and major birth defects, miscarriage, or adverse maternal or fetal outcomes when insulin glargine is used during pregnancy. However, these studies cannot definitely establish the absence of any risk because of methodological limitations including small sample size and some lacking comparator groups.
Animal Data Subcutaneous reproduction and teratology studies have been performed with insulin glargine and regular human insulin in rats and Himalayan rabbits. Insulin glargine was given to female rats before mating, during mating, and throughout pregnancy at doses up to 0.36 mg/kg/day, which is approximately 50 times the recommended human subcutaneous starting dosage of 0.2 units/kg/day (0.007 mg/kg/day), on a mg/kg basis. In rabbits, doses of 0.072 mg/kg/day, which is approximately 10 times the recommended human subcutaneous starting dosage of 0.2 units/kg/day on a mg/kg basis, were administered during organogenesis.
The effects of insulin glargine did not generally differ from those observed with regular human insulin in rats or rabbits. However, in rabbits, five fetuses from two litters of the high-dose group exhibited dilation of the cerebral ventricles. Fertility and early embryonic development appeared normal.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of Insulin Glargine - yfgn to improve glycemic control in pediatric patients with diabetes mellitus have been established. Use of Insulin Glargine for this indication is supported by Insulin Glargine - yfgn’s approval as a biosimilar to insulin glargine and evidence from an adequate and well-controlled study (Study D) in 174 insulin glargine-treated pediatric patients aged 6 to 15 years with type 1 diabetes mellitus, and from adequate and well-controlled studies of insulin glargine in adults with diabetes mellitus [see Clinical Pharmacology (12.3) , Clinical Studies (14.2) ] .
In the pediatric clinical study, pediatric patients with type 1 diabetes had a higher incidence of severe symptomatic hypoglycemia compared to the adults in studies with type 1 diabetes [see Adverse Reactions (6.1) ] .
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of subjects in controlled clinical studies of patients with type 1 and type 2 diabetes who were treated with insulin glargine, 15% (n = 316) were ≥ 65 years of age and 2% (n = 42) were ≥ 75 years of age. No overall differences in safety or effectiveness of insulin glargine have been observed between patients 65 years of age and older and younger adult patients. Nevertheless, caution should be exercised when Insulin Glargine-yfgn is administered to geriatric patients.
In geriatric patients with diabetes, the initial dosing, dosage increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions. Hypoglycemia may be difficult to recognize in geriatric patients.
🆘 Overdosage ▾
10 OVERDOSAGE Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions (5.3 , 5.6) ] . Mild episodes of hypoglycemia can usually be treated with oral carbohydrates. Lowering the insulin dosage, and adjustments in meal patterns or exercise may be needed.
More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with glucagon for emergency use or concentrated intravenous glucose. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid recurrence of hypoglycemia. Hypokalemia must be corrected appropriately.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The primary activity of insulin, including insulin glargine products, is 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 In clinical studies, the glucose-lowering effect on a molar basis (i.e., when given at the same doses) of intravenous insulin glargine is approximately the same as that for human insulin. Figure 1 shows results from a study in patients with type 1 diabetes conducted for a maximum of 24 hours after subcutaneous injection of insulin glargine or NPH insulin. The median time between subcutaneous injection and the end of pharmacological effect was 14.5 hours (range: 9.5 to 19.3 hours) for NPH insulin, and 24 hours (range: 10.8 to > 24 hours) (24 hours was the end of the observation period) for insulin glargine.
Figure 1: Glucose-Lowering Effect Over 24 Hours in Patients with Type 1 Diabetes * Determined as amount of glucose infused to maintain constant plasma glucose levels The duration of action after abdominal, deltoid, or thigh subcutaneous administration of insulin glargine was similar. The time course of action of insulins, including insulin glargine products, may vary between patients and within the same patient. Glucose-Lowering Effect Over 24 Hours in Patients with Type 1 Diabetes
12.3Pharmacokinetics Absorption After subcutaneous injection of insulin glargine in healthy subjects and in patients with diabetes, the insulin serum concentrations indicated a slower, more prolonged absorption and a relatively constant concentration/time profile over 24 hours with no pronounced peak in comparison to NPH insulin. Elimination Metabolism A metabolism study in humans indicates that insulin glargine is partly metabolized at the carboxyl terminus of the B chain in the subcutaneous depot to form two active metabolites with in vitro activity similar to that of human insulin, M1 (21 A -Gly-insulin) and M2 (21 A -Gly-des- 30 B -Thr-insulin).
Unchanged drug and these degradation products are also present in the circulation. Specific Populations Age, Race, Body Mass Index, and Gender Effect of age, race, body mass index (BMI), and gender on the pharmacokinetics of insulin glargine products has not been evaluated. However, in controlled clinical studies in adults (n = 3,890) and a controlled clinical study in pediatric patients (n = 349), subgroup analyses based on age, race, BMI, and gender did not show differences in safety and efficacy between insulin glargine and NPH insulin [see Clinical Studies (14) ] .
🧬 Mechanism of Action ▾
12.1Mechanism of Action The primary activity of insulin, including insulin glargine products, is 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 Insulin Glargine-yfgn (injection) is supplied as a clear and colorless solution containing 100 units/mL (U-100) available as follows: Insulin Glargine-yfgn NDC Number Package Size 10 mL multiple-dose vial 83257-014-11 1 vial per carton 3 mL single-patient-use prefilled pen 83257-015-31 1 pen per carton 83257-015-32 5 pens per carton Additional Information about Insulin Glargine-yfgn: • The Insulin Glargine-yfgn prefilled pen dials in 1-unit increments. • Needles are not included in the packs. Embecta Ultra Fine needles are compatible with this pen.
16.2Storage Dispense in the original sealed carton with the enclosed Instructions for Use. Store unused Insulin Glargine-yfgn in a refrigerator between 2° to 8°C (36° to 46°F). Do not freeze.
Discard Insulin Glargine-yfgn if it has been frozen. Protect Insulin Glargine-yfgn from direct heat and light. Storage conditions are summarized in the following table: Not in-use (unopened) Refrigerated (2° to 8°C [36° to 46°F]) Not in-use (unopened) Room Temperature (up to 30°C [86°F]) In-use (opened) (see temperature below) 10 mL multiple-dose vial Until expiration date 28 days 28 days Refrigerated or room temperature 3 mL single-patient-use prefilled pen Until expiration date 28 days 28 days Room temperature only (Do not refrigerate)
📋 Description ▾
11 DESCRIPTION Insulin glargine-yfgn is a long-acting human insulin analog produced by recombinant DNA technology utilizing a recombinant yeast strain, Pichia pastoris. Insulin glargine-yfgn differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine-yfgn has a molecular weight of 6063 Da.
Insulin Glargine-yfgn is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial and a 3 mL single-patient-use prefilled pen. Prefilled Pen and Vial: Each mL contains 100 units of insulin glargine-yfgn and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), zinc chloride (content adjusted to provide 30 mcg zinc ion), and Water for Injection, USP. The vial also contains polysorbate 20 (20 mcg).
The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. Insulin Glargine - yfgn has a pH of approximately 4.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). There are separate Instructions for Use for the vial and prefilled pen. Never Share an Insulin Glargine-yfgn Prefilled Pen or Insulin Syringe Between Patients Advise patients that they must never share a Insulin Glargine-yfgn prefilled pen with another person, even if the needle is changed.
Advise patients using Insulin Glargine-yfgn vials not to re-use or share needles or insulin syringes with another person. Sharing carries 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.
Inform patients of the symptoms of hypoglycemia (e.g., impaired ability to concentrate and react). This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery [see Warnings and Precautions (5.3) ] .
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 Due to Medication Errors Instruct patients to always check the insulin label before each injection to reduce the risk of a medication error [see Warnings and Precautions (5.4) ] . Hypersensitivity Reactions Advise patients that hypersensitivity reactions have occurred with insulin glargine products.
Inform patients about the symptoms of hypersensitivity reactions [see Warnings and Precautions (5.5) ] . LANTUS is a registered trademark of Sanofi-Aventis Deutschland gmbh. Manufactured by: Biocon Biologics Inc.
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