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IMPORTANT SAFETY INFORMATION AND INDICATIONS
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Insulin Glargine-yfgn is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin glargine products or any of the excipients in Insulin Glargine-yfgn.
WARNINGS AND PRECAUTIONS
Insulin pens, needles, or syringes must never be shared between patients. Do NOT reuse needles.
Monitor blood glucose in all patients treated with insulin. 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 or hyperglycemia. Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring.
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. Advise patients to rotate the injection site to unaffected areas and closely monitor for hypoglycemia.
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 and reaction time.
Accidental mix-ups between insulin products have been reported. To avoid medication errors between Insulin Glargine-yfgn and other insulins, instruct patients to always check the insulin label before each injection.
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Insulin Glargine-yfgn, treat and monitor until symptoms and signs resolve.
All insulin products, including Insulin Glargine-yfgn, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia, if indicated.
Fluid retention, which may lead to or exacerbate heart failure can occur with concomitant use of thiazolidinediones (TZDs) with insulin. These patients should be observed for signs and symptoms of heart failure. If heart failure develops, dosage reduction or discontinuation of the TZD must be considered.
Do not dilute or mix Insulin Glargine-yfgn with any other insulin or solution. If mixed or diluted, the solution may become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner. Do not administer Insulin Glargine-yfgn via an insulin pump or intravenously because hypoglycemia can occur.
A reduction in the Insulin Glargine-yfgn dose may be required in patients with renal or hepatic impairment.
ADVERSE REACTIONS
Adverse reactions commonly associated with insulin glargine products include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritis, rash, edema, and weight gain.
DRUG INTERACTIONS
Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs of hypoglycemia may be reduced in patients taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine).
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.
INDICATIONS AND USAGE
Insulin Glargine-yfgn injection 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.
Please see Full Prescribing Information for Insulin Glargine-yfgn.