Full Press Release Details
INDIANAPOLIS , June 8, 2011 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY ) today 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:
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. See Important Safety Information below, and additional information about Humalog is available at www.humalog.com .
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®?
Who should not take Humalog?
Do not take Humalog if:
What should I tell my healthcare providers before using Humalog?
Tell all of your healthcare providers:
How should I use Humalog?
What are the possible side effects of Humalog?
You are encouraged to report negative side effects of Prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
How should I store Humalog?
What is some general information about the use of Humalog in a pump?
Humalog is available by prescription only.
For more information about Humalog, please see the 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 ).
Please see full user manual that accompanies the pen.
(1) D-Tron® and D-Tronplus® are registered trademarks of Roche Diagnostics GmbH.
HI CON ISI 24MAY2011
About Eli Lilly and Company
Lilly, a leading, innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind. , Lilly provides answers—through medicines and information—for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com .
About Lilly Diabetes
For more than 85 years, Lilly has been a worldwide leader in pioneering industry-leading solutions to support people living with and treating diabetes. Lilly introduced the world's first commercial insulin in 1923 and remains at the forefront of medical and delivery device innovation to manage diabetes. Lilly is also committed to providing solutions beyond therapy -practical tools, education, and support programs to help overcome barriers to success along the diabetes journey. At Lilly, the journeys of each person living with or treating diabetes inspire ours.
Humalog® is a registered trademark of Eli Lilly and Company and is available by prescription only.
SOURCE Eli Lilly and Company