FDA Approves Humulin R U-500 KwikPen for Insulin Injection

The FDA has approved Humulin R U-500 KwikPen, which is 5 times more concentrated than standard insulin injections.

The U.S. Food and Drug Administration (FDA) approved the Humulin R U-500 KwikPen (Eli Lilly and Company), for use in patients with type 1 or type 2 diabetes, according to a press release.

The U-500 KwikPen is a pre-filled device containing 500 units/mL of Humulin R U-500, which is normally used to treat individuals with type 1 and type 2 diabetes who need more than 200 units of insulin per day. Before the FDA approval, Humulin R U-500 was only available in a vial, and it was administered with a U-100 insulin syringe or a volumetric syringe that uses syringe volume markings.

“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 Jackson, MD, FACE, CDE, Medical Fellow, US Medical Affairs, Lilly Diabetes, in the release.

“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.”

Each U-500 KwikPen holds 1500 units of insulin, which is equivalent to the amount in 5 U-100 insulin pens. It is the same size as other U-100 KwikPens, has a unique aqua-colored pen body, and dials in 5-unit increments.

Humulin R U-500 should not be used during episodes of hypoglycemia or in patients that could be sensitive to the insulin. Extreme caution should be taken when measuring Humulin R U-500 doses, because inadvertent overdose could cause serious adverse reactions. No dose conversion is required for the KwikPen, but patients should be counseled to dial and dose the prescribed amount of insulin.

The FDA has not determined the safety and efficacy of using Humulin R U-500 with other insulins or insulin infusion pumps.

Dr Jackson notes that the U-500 KwikPen, “will provide an additional treatment option to help people with severely insulin-resistant diabetes improve control of their blood sugar levels, with 80% less liquid volume, and usually 2 or 3 injections per day.”


  1. Humulin R U-500 KwikPen may improve glycemic control in people with severely insulin-resistant diabetes [press release]. Indianapolis, IN: Eli Lilly and Company; January 21, 2016. https://investor.lilly.com/releasedetail.cfm?ReleaseID=951175. Accessed January 21, 2016.