Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
Prefilled Insulin Pen Approved
Humulin was previously available only in vials
The FDA has approved Humulin R U-500 KwikPen (insulin human injection) 500 units/mL. Until now, Humulin R U-500 was available only in a vial.
Indications: Humulin R U-500 is a concentrated human insulin indicated to improve glycemic control in adults and children with diabetes requiring more than 200 units of insulin per day.
Dosage and administration: Humulin R U-500 is now available as a 3 mL KwikPen (prefilled, 1,500 units of insulin).
• Administer subcutaneously 2 or 3 times daily 30 minutes before a meal.
• Do not perform dose conversion when using the KwikPen.
• Do not transfer insulin from the KwikPen into a syringe.
Efficacy and safety: The safety and efficacy of Humulin R U-500 used in combination with other insulins or delivered by continuous subcutaneous infusion has not been determined.
Side effects/risks: Adverse reactions include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash.
Citation: US Food and Drug Administration approves Humulin R U-500 KwikPen [news release]. Indianapolis, IN: Eli Lilly and Company; January 21, 2016. https://investor.lilly.com/releaseDetail.cfm?ReleaseID=951175. Accessed January 26, 2016.
Humulin R U-500 [package insert]. Indianapolis, IN: Eli Lilly and Company; 2015. http://pi.lilly.com/us/humulin-r-u500-pi.pdf. Accessed January 26, 2016.