BASAGLAR® (insulin glargine injection 100 units/mL) Product Monograph

DECEMBER 12, 2016
This BASAGLAR® (insulin glargine injection) 100 units/mL Product Monograph was developed by Plantsvszombies.info, with editorial and financial support provided by Boehringer Ingelheim Pharmaceuticals, Inc, and Eli Lilly and Company.

BASAGLAR will be available in the United States after December 15, 2016. Specific timing on product availability may vary by location.
 
Plantsvszombies.info has made available a Product Monograph on this treatment option for diabetes. 

To access the Product Monograph,  or the image below.


Indication and Limitation of Use

BASAGLAR® (insulin glargine injection) is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. BASAGLAR is not recommended for the treatment of diabetic ketoacidosis.

IMPORTANT SAFETY INFORMATION

Contraindications
BASAGLAR is contraindicated during episodes of hypoglycemia, and in patients with hypersensitivity to insulin glargine or one of its excipients.

Warnings and Precautions
BASAGLAR KwikPen® must never be shared between patients, even if the needle is changed. Sharing poses a risk of transmission of blood borne pathogens.

Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. These changes should be made cautiously and only under close medical supervision, and the frequency of blood glucose monitoring should be increased. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.

Hypoglycemia is the most common adverse reaction associated with insulins, including BASAGLAR. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death.

Accidental mix-ups between another insulin glargine product (100 units/mL) and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors between BASAGLAR and other insulins, instruct patients to always check the insulin label before each injection.

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including BASAGLAR. If hypersensitivity reactions occur, discontinue BASAGLAR; treat per standard of care and monitor until symptoms and signs resolve. BASAGLAR is contraindicated in patients who have had hypersensitivity reactions to insulin glargine or one of the excipients.

All insulin products, including BASAGLAR, 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.

Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. These patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of TZD must be considered.

Adverse Reactions
Adverse reactions commonly associated with insulin glargine products (5% or greater incidence) are: hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, 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 and symptoms of hypoglycemia may be blunted when beta-blockers, clonidine, guanethidine, and reserpine are co-administered with BASAGLAR.

 

BV HCP ISI 24JUN2016


BASAGLAR is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.
KwikPen is a registered trademark of Eli Lilly and Company.
PP-BV-US-0333 11/2016 ©Lilly USA, LLC 2016. All rights reserved.

 

For more information, please see Full , including , and .
 

 



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