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FDA Approves Basaglar for Diabetes
New form of pen-like injector
The FDA approved Basaglar (insulin glargine injection), a long-acting human insulin analog to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
Indications: Basaglar is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
Dosage/Administration: Individualized dosage based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, and prior insulin use. Administer subcutaneously once daily at any time of the day, but at the same time every day. Injection dosage is 100 units/mL in 3 mL prefilled Basaglar KwikPen delivery device.
Adverse Reactions: Adverse reactions commonly associated with insulin glargine products (≥5% incidence) include hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, rash, edema, and weight gain.
Citation: U.S. Food and Drug Administration. FDA approves Basaglar, the first “follow-up” insulin glargine product to treat diabetes. FDA Web site. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm477734.htm. Accessed December 21, 2015.