The U.S. Food and Drug Administration has approved 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. Humulin R U-500 is the only FDA-approved insulin that is five-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.

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. Although each U-500 KwikPen holds 1500 units of insulin (the amount in five U-100 insulin pens), it is the same size as other KwikPens and dials in five-unit increments.

The U-500 KwikPen has a unique aqua-colored pen body to clearly differentiate it from other insulin pens. Humulin R U-500 is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Humulin R U-500 or any of its additives or components. Hypoglycemia (low blood sugar) is the most common side effect associated with all insulins, including Humulin R U-500.

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 twelve month period.