Europe — EMA
Abasaglar (previously Abasria)
Abasaglar (insulin glargine) 3.64 mg injection solution – long‑acting basal insulin for type 1 and type 2 diabetes, mechanism, uses, side effects, and safety information.
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What is Insulin Glargine?
Abasaglar is a brand‑name solution for injection that contains the long‑acting insulin analog insulin glargine at a strength of 3.64 mg per vial. It is marketed in the European Union as a prescription‑only product for subcutaneous administration to provide basal insulin coverage in diabetes management.
What is Insulin Glargine used for?
Abasaglar is indicated for the basal insulin needs of adults with diabetes. It is used as part of a comprehensive diabetes treatment plan that may include diet, exercise, and other medications.
- Long‑acting basal insulin for type 1 diabetes mellitus. - Long‑acting basal insulin for type 2 diabetes mellitus. - Adjunct therapy when oral antidiabetic agents are insufficient. - Replacement therapy in patients transitioning from other basal insulins. - Support for stable glycemic control in combination with rapid‑acting insulins.
What are the side effects of Insulin Glargine?
Adverse reactions to Abasaglar can vary in frequency and severity.
Common: - Injection‑site pain or erythema. - Hypoglycemia (low blood glucose). - Lipodystrophy at the injection site. - Mild weight gain. - Transient edema.
Serious: - Severe hypoglycemia requiring assistance. - Allergic reactions such as urticaria or angioedema. - Persistent or severe injection‑site infection. - Unexplained weight loss. - Acute metabolic acidosis (rare).
What precautions apply to Insulin Glargine?
Before initiating Abasaglar, several safety considerations should be reviewed.
- Assess renal and hepatic function, as impairment may alter insulin requirements. - Monitor blood glucose closely during dose adjustments or when changing insulin regimens. - Use caution in patients with a history of severe hypoglycemia or hypoglycemia unawareness. - Evaluate pregnancy status; insulin is the preferred agent, but data are limited for this specific formulation. - Educate patients on proper injection technique to reduce lipodystrophy risk. - Store the product according to label instructions to maintain potency.
What does Insulin Glargine interact with?
Abasaglar may interact with other agents that affect glucose metabolism or insulin action.
Avoid: - Concurrent use of other basal insulins without dose adjustment. - High‑dose corticosteroids or sympathomimetics that can raise blood glucose markedly. - Certain oral antidiabetic agents (e.g., sulfonylureas) that increase hypoglycemia risk when combined.
Use with caution: - Beta‑blockers, which may mask hypoglycemia symptoms. - ACE inhibitors or ARBs, which can potentiate insulin’s glucose‑lowering effect. - Alcohol consumption, as it can cause unpredictable glucose fluctuations. - Thyroid hormone therapy, which may alter insulin sensitivity.
Frequently asked questions
What type of insulin is Abasaglar and how is it classified?+
For which patients is Abasaglar typically prescribed?+
How is Abasaglar administered?+
Can Abasaglar be used together with rapid‑acting insulins?+
What are the most common side effects of Abasaglar?+
What serious adverse reactions should patients be aware of?+
How should Abasaglar be stored before use?+
Is dose adjustment needed when starting Abasaglar?+
What medications should be avoided while using Abasaglar?+
Are there any special considerations for pregnant women using Abasaglar?+
What monitoring is recommended after initiating Abasaglar?+
Can alcohol consumption affect the action of Abasaglar?+
Product details
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