INSULIN GLARGINE- insulin glargine-yfgn injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INSULIN GLARGINE (UNII: 2ZM8CX04RZ) (INSULIN GLARGINE - UNII:2ZM8CX04RZ)

Available from:

Biocon Biologics Inc.

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 contraindicated: 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 r

Product summary:

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 3 mL single-patient-use prefilled pen 83257-015-31 1 pen 83257-015-32 5 pens   Additional Information about Insulin Glargine-yfgn: BD® Ultra-Fine needles are compatible with this pen. 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)  

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

INSULIN GLARGINE- INSULIN GLARGINE-YFGN INJECTION, SOLUTION
BIOCON BIOLOGICS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INSULIN GLARGINE-YFGN
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR INSULIN
GLARGINE-YFGN.
INSULIN GLARGINE-YFGN INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2021
THIS PRODUCT IS SEMGLEE (INSULIN GLARGINE-YFGN). SEMGLEE (INSULIN
GLARGINE-YFGN) IS
INTERCHANGEABLE* WITH LANTUS (INSULIN GLARGINE).
INDICATIONS AND USAGE
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
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DOSAGE FORMS AND STRENGTHS
Injection: 100 units/mL (U-100) available as:
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Individualize dosage based on metabolic needs, blood glucose
monitoring, glycemic control, type of
diabetes, and prior insulin use. (2.1, 2.2, 2.3, 2.4)
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 and how to change to Insulin Glargine-yfgn from other
insulins. (2.3, 2.4)
Closely monitor glucose when switching to Insulin Glargine-yfgn and
during initial weeks thereafter.
(2.4)
10 mL multiple-dose vial (3)
3 mL single-patient-use prefilled pen (3)
During episodes of hypoglycemia (4)
Hypersensitivity to insulin glargine products or any excipient in
Insulin Glargine-yfgn (4)
_Never share_ an Insulin Glargine-yfgn prefilled pen, insulin syringe,
or needle between patients, even if
the needle is c