FDA Approves Updates to Lilly's Humalog (Insulin Lispro Injection)

Strategic Insights -

The U.S. Food and Drug Administration (FDA) has approved updates to the label for Eli Lilly and Company's Humalog (insulin lispro injection), a rapid-acting insulin used to treat people with diabetes. The updated label now allows people with type 1 diabetes using Humalog for pump therapy to use the insulin in the pump reservoir for up to seven days, with changes to the infusion set and infusion site at least every three days. This approval reflects Lilly Diabetes' commitment to providing personalized solutions that meet the everyday needs of people with diabetes.

Key Takeaways:

  • The updated label for Humalog (insulin lispro injection) allows people with type 1 diabetes using the insulin for pump therapy to use the insulin in the pump reservoir for up to seven days.
  • People with type 1 diabetes using Humalog for pump therapy should change the infusion set and infusion set insertion site at least every three days.
  • The previous label indicated that Humalog in the external insulin pump reservoir should be replaced and a new infusion site selected every 48 hours or less.
  • Humalog, containing 100 units per mL, is used to treat people with diabetes for the control of high blood sugar.
  • The insulin should not be taken by someone with low blood sugar (hypoglycemia) or by someone who is allergic to insulin lispro or any of the ingredients in Humalog.
  • Patients should closely monitor their blood glucose and make changes to their insulin regimen cautiously and only under medical supervision.
  • Insulin pumps deliver insulin 24 hours a day through a catheter placed under the skin, and Humalog is recommended for use in pump systems indicated for continuous delivery of fast-acting insulin.
  • The label updates reflect Lilly Diabetes' commitment to providing personalized solutions that meet the everyday needs of people with diabetes.

Statistics:

  • Up to 7 days: duration of using Humalog (insulin lispro injection) in the pump reservoir.
  • Every 3 days: frequency of changing the infusion set and infusion site for people with type 1 diabetes using Humalog for pump therapy.
  • 48 hours or less: previous recommendation for replacing Humalog in the external insulin pump reservoir and selecting a new infusion site.

Sources:

  • Food and Drug Administration (FDA) approval of the supplemental new drug application (sNDA) for Humalog.
  • Eli Lilly and Company press release on June 8, 2011 (Puls, C., (317) 612-4859; pulsca@lilly.com).
  • Full Prescribing Information (http://pi.lilly.com/us/humalog-pen-pi.pdf) and Patient Prescribing Information (http://pi.lilly.com/us/humalog-pen-ppi.pdf) for Humalog.