U-500 Insulin Pen Approved by FDA

The FDA today approved Eli Lilly’s Humulin R U-500 insulin human injection (KwikPen) for patients with type 1 and type 2 diabetes who need more than 200 units of insulin per day.

The pre-filled device offers a highly concentrated formulation of insulin, and the product is the only FDA-approved insulin that is 5 times more concentrated than the U-100 insulin.

This product could help curb dosing errors related to administration, since there had been no syringes on the market specifically for U-500 insulin.

Humulin R U-500 was only available in a vial, which was either administered via syringes for U-100 insulin (which could lead to dangerous errors considering that U-500 delivers 5 times more insulin in each mL of fluid) or via a tuberculin syringe that required conversion to the appropriate syringe unit markings.

Pharmacists and other health care providers will be able to differentiate this product from other insulin pens because the Humulin R U-500 has a “unique” aqua-colored pen body, Eli Lilly said in a press release.

It is the same size as other KwikPens and dials in 5-unit increments.

"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, in a press 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."

Currently, there is no data on the safety and efficacy of using the Humulin R U-500 with other insulins.

The product is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Humulin R U-500.

Like all insulins, hypoglycemia is the most common adverse effect associated with Humulin R U-500.

Patients may be able to enroll in the Humulin R U-500 Savings Card Program, which would allow certain commercially insured patients to pay $25 per prescription for up to 12 redemptions over a 1-year period.