FDA Approves First U-500 Insulin Pen Device

Miriam E Tucker

January 27, 2016

The US Food and Drug Administration (FDA) has approved the first prefilled pen device containing concentrated U-500 strength insulin (Humulin R U-500 KwikPen [insulin human injection] 500 units/mL, Eli Lilly) for diabetes patients who require more than 200 units per day.

The product is designed as a more convenient alternative to the current U-500 vial, which requires use of either a syringe designed for U-100 strength insulin or a volumetric (tuberculin) syringe, both of which require dose conversions.

Each KwikPen holds 1500 units of insulin (3 mL, with each mL containing 500 units), the amount contained in five U-100 insulin pens. However, it is the same size as other Lilly KwikPens and dials in five-unit increments.

"The U-500 KwikPen was specifically designed as a dedicated dosing device to eliminate the need for dose conversion, as compared with use of the vial and syringe options, which some people may find to be an improvement," Kevin Cammack, senior marketing director, United States, Lilly Diabetes, told Medscape Medical News.

Humulin R U-500 exhibits both basal and prandial properties, allowing it to be used as insulin monotherapy. This effect has been attributed to the high concentration of the preparation, Mr Cammack noted.

As with other insulins, Humulin R U-500 is contraindicated during hypoglycemic episodes and in patients hypersensitive to Humulin R U-500 or any of its additives or components.

Lilly offers a savings-card program for eligible commercially insured patients to pay as little as $25 per prescription for up to 12 redemptions over a 12-month period.

This FDA approval is the first in the world for the Humulin R U-500 KwikPen. Humulin R U-500 insulin is currently only approved and marketed in the United States, and Lilly has not filed for approval in markets outside the United States.

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