The U.S. 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
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 12-month period.
