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FDA Approves Lilly’s Humulin® R U-500 KwikPen®

New pen may improve glycemic control in people with severely insulin-resistant diabetes.

For the first time Humulin % U-500 will now be available in a pen. This will help to prevent all the errors that this insulin has had in the past because of the confusion with units and cc’s. The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company’s Humulin® R U-500 KwikPen® (insulin human injection) 500 units/mL, a pre-filled device containing Humulin R U-500, a highly concentrated formulation of insulin. Humulin R U-500 is the only FDA-approved insulin that is five times more concentrated than standard U-100 insulin. This insulin is used to treat high blood sugar in people with type 1 and type 2 diabetes who need more than 200 units of insulin per day. The safety and efficacy of Humulin R U-500 used in combination with other insulins or delivered by an insulin infusion pump has not been determined.

“People with diabetes and severe insulin resistance who have become poorly responsive to the effects of insulin may require much higher insulin doses – more than 200 units per day – to help keep their blood sugar levels on target,” said Jeffrey A. Jackson, MD, FACE, CDE, Medical Fellow, US Medical Affairs, Lilly Diabetes. “For these patients, the U-500 KwikPen is now available as a convenient alternate option to deliver a large dose of insulin in a reasonable volume. It was specifically designed as a dedicated dosing device to eliminate the need for dose conversion, as compared to use of the vial and syringe options, which some people may find to be an improvement.”

Until now, Humulin R U-500 was only available in a vial, administered with either a U-100 insulin syringe or a volumetric (tuberculin) syringe that requires conversion to respective syringe “unit markings” or volume markings. Although each U-500 KwikPen holds 1500 units of insulin (the amount in five U-100 insulin pens), it is the same size as other KwikPens and dials in five-unit increments. The U-500 KwikPen has a unique aqua-colored pen body to clearly differentiate it from other insulin pens. Healthcare professionals can click here to see the U-500 KwikPen in action.

The new Humulin R U-500 KwikPen dials and doses the insulin units prescribed. Similar to other insulin pens, there’s no dose conversion with the U-500 KwikPen. If you prescribe 100 units of U-500 with this KwikPen, the patient will dial to 100 to get the insulin needed. In contrast, if you prescribe 100 units with the U-500 vial and the U-100 insulin syringe, the patient would draw to the 20-unit marking.

Prescribing Information and Patient Information.

Eli Lilly Press Release 1-21-2016