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FDA Approves Admelog ‘Follow-On’ Insulin
FDA news release; 2017 Dec 11
The FDA has approved Admelog (insulin lispro injection) to improve control in blood sugar levels in patients with types 1 or 2 diabetes.
Indications: Admelog is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients aged ≥3 years with type 1 diabetes or adults with type 2 diabetes.
Dosage and administration: Individualize dose based on the route of administration and the individual's metabolic needs, blood glucose monitoring results, and glycemic control goal:
- Subcutaneous injection: Administer within 15 minutes before a meal or immediately after a meal.
- Continuous subcutaneous infusion: Administer using an insulin pump.
- Intravenous infusion: Administer only after dilution and under medical supervision.
Efficacy and safety: Admelog was approved through an abbreviated approval pathway relying on Humalog’s previously-approved safety and efficacy.
Side effects/risks: The most common adverse reactions are hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash.
FDA approves Admelog, the first short-acting "follow-on" insulin product to treat diabetes. [news release]. Silver Spring, MD: FDA. December 11, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm588466.htm?utm_campaign=12112017_FDA%20approves%20Admelog&utm_medium=email&utm_source=Eloqua. Accessed December 13, 2017.
Admelog [package insert]. Bridgewater, NJ: sanofi-aventis U.S. LLC. 2017. http://products.sanofi.us/Admelog/Admelog.pdf. Accessed December 13, 2017.