FDA Okays Lilly’s Prefilled Device for Concentrated Insulin
The US Food and Drug Administration (FDA) 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 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.
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.
Source: Eli Lilly and Company