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Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) approved the company’s supplemental new drug application (sNDA) with the following updates to the Humalog label:
– continuous insulin infusion pump therapy in children 4 years of age and over with type 1 diabetes
– extension of the time-in-use in the external pump reservoir to a maximum of seven days; and
– extension of the time-in-use of the infusion set and of the infusion set subcutaneous insertion site to a maximum of three days.
Based on the updated label, people with type 1 diabetes using Humalog for pump therapy can use the insulin in the pump reservoir for up to seven days and 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, which contains 100 units per mL, is used to treat people with diabetes for the control of high blood sugar. Humalog 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. Humalog is recommended for use in pump systems indicated for continuous delivery of fast-acting insulin. All people treated with insulin 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. Rapid-acting insulin is delivered continuously to help keep blood glucose levels in a specified range between meals, after meals and overnight.
“Insulin pumps can be an additional option for people using rapid-acting insulin and allow people to manage their type 1 diabetes around their lifestyle,” said Dana Hardin, MD, a pediatric endocrinologist and clinical research physician at Lilly. “These Humalog label updates reflect Lilly Diabetes’ commitment to providing people with personalized solutions that meet their everyday needs.”
In coordination with these label updates, the package insert for Humalog also was updated in accordance with the Physician’s Labeling Rule (PLR) format.
Important Safety Information for Humalog
What is the most important information I should know about Humalog®?
– Do not change the insulin you use without talking to your healthcare provider. Any change in insulin strength, manufacturer, or type may need a change in the dose you are using. Doses of oral antidiabetic medicines may also need to change if your insulin is changed.
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