High-dose insulin pen hits market

A new insulin pen has hit the market - 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.

However, the new insulin is different from other products because it is the only FDA-approved insulin that is 5 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.

FDA also approved insulin degludec injection (Tresiba, Novo Nordisk) and insulin degludec/insulin aspart injection (Ryzodeg 70/30, Novo Nordisk) for the treatment of diabetes mellitus last fall.

Related: FDA approves long-acting insulin drugs

"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, medical Fellow for 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."

However, 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.

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.

The conversion requirement leads to medication errors in some cases, according to the Institute for Safe Medication Practices (ISMP).

Related: ADA: Studies point to safety, efficacy profile for new insulin glargine product

Humulin R U-500 is also contraindicated during episodes of hypoglycemia and in patients hypersensitive to Humulin R U-500 or any of its additives or components.

Although each U-500 KwikPen holds 1500 units of insulin (the amount in 5 U-100 insulin pens), it is the same size as other KwikPens and dials in 5-unit increments. The U-500 KwikPen has a unique aqua-colored pen body to clearly differentiate it from other insulin pens.

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.

Read more: New insulin drug to enter crowded market