FDA Approves First U-500 Insulin Pen

(Humulin(R) R U-500 KwikPen(R) (PRNewsFoto/Eli Lilly and Company))

On January 21, 2016, the U.S. Food and Drug Administration (FDA) approved the Humulin R U-500 KwikPen (insulin human injection) 500 units/ml for people with Type 1 and Type 2 diabetes who need more than 200 units of insulin per day. The device, which is manufactured by pharmaceutical company Eli Lilly and Company, is the first insulin pen to be approved for delivering U-500 insulin.

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U-500 insulin is five times as concentrated as standard U-100 insulin, and is generally used to treat people who have severe insulin resistance. Larger volumes of insulin are absorbed less predictably and therefore have less predictable effects on blood sugar levels. Because a dose of U-500 insulin takes only one-fifth the volume of the same dose of U-100 insulin, this variability is reduced.

Until this approval, Humulin R U-500 has only been available in a vial, administered either through a U-100 or TB syringe and requiring conversion to the syringe unit markings. This new prefilled pen is specifically designed for U-500 insulin, potentially helping to prevent dosing errors. The device is the same size as other KwikPens (in an aqua color), but it dials in 5-unit increments and holds 1,500 units of insulin — the amount contained in five U-100 insulin pens. Unopened pens should be kept in the refrigerator, and in-use pens should be kept at room temperature. Once open, Humulin R U-500 KwikPens should be thrown out after 28 days, even if insulin remains.

The pen is expected to hit the market in April 2016. According to Eli Lilly, “the Humulin R U-500 Savings Card Program offers eligible, commercially insured patients the opportunity to pay as little as $25 per prescription for up to 12 redemptions over a 12-month period.” (Learn more about the program here.)

There is currently no safety data regarding the use of Humulin R U-500 with other insulins or in an insulin pump. The medicine should not be used during episodes of hypoglycemia (low blood sugar) or in those who are allergic to any of the ingredients. The most common side effect of Humulin R U-500 is hypoglycemia.

For more information about the Humulin R U-500 KwikPen, see the press release on the Eli Lilly website. And for more information about U-500 insulin, read the article “U-500 Insulin: Is It Right for You?,” by certified diabetes educator Amy Campbell.

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