FDA Approves Humalog U-200 KwikPen

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The FDA has approved a Humalog U-200 KwikPen that holds twice the amount of insulin as the U-100 formulation.

The U.S. Food and Drug Administration (FDA) has approved the Humalog U-200 KwikPen (insulin lispro 200 U/mL), a prefilled pen that holds twice the amount of rapid-acting insulin as the Humalog U-100 formulation, to improve glycemic control in patients with type 1 and type 2 diabetes, according to a press release from Eli Lilly and Company.

The Humalog U-200 KwikPen holds 600 units of insulin, compared with 300 units held by the Humalog U-100 formulation, in the same 3-mL cartridge. The newly approved product offers patients a pen that lasts longer between pen changes, which may lead to fewer pen changes per month.

Once opened, the pens should be discarded after 28 days, regardless of whether any insulin remains.

The release states that Humalog U-200 KwikPen delivers the same dose in half the volume of Humalog U-100 KwikPen with no dose conversions required and can be dialed in 1-unit increments to a maximum of 60 units per injection.

The FDA based its approval on data from a pharmacokinetic/pharmacodynamic study evaluating the bioequivalence of Humalog 200 U/mL relative to Humalog 100 U/mL. Common side effects include hypoglycemia that may be severe and could cause unconsciousness, seizures and death.

Dosage and administration information states the following:

  • Humalog should be given within 15 minutes before or immediately after a meal.
  • Do not administer Humalog U-200 intravenously.
  • Do not mix Humalog U-200 in a syringe with any other insulin.
  • Do not use Humalog U-200 in a subcutaneous insulin infusion pump.
  • Do not perform dose conversion when using either the Humalog U-100 or Humalog U-200 KwikPens. The dose window shows the number of insulin units to be delivered and no conversion is needed.

To learn more about dosing and safety, read full prescribing information.

Diabetes is a progressive disease that often requires increased doses of insulin over time to better control a patient’s blood sugar levels,” David Kendall, MD, vice president of Medical Affairs at Lilly Diabetes, said in the release. “Humalog U-200 KwikPen represents a new option for people with diabetes. Fewer pen changes per month may help people who require higher daily doses of mealtime insulin better fit their treatment in their daily lives.”