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FDA Approves Updates to Lilly's Humalog® (insulin lispro injection [rDNA origin]) Label
Date:6/8/2011

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.
  • You must test your blood sugar levels while using an insulin such as Humalog. Your healthcare provider will tell you how often you should test your blood sugar level.
  • When used in a pump, do not mix Humalog with any other insulin or liquid.

Who should not take Humalog?  

Do not take Humalog if:

  • your blood sugar is too low (hypoglycemia).
  • you are allergic to insulin lispro or any of the ingredients in Humalog.

What should I tell my healthcare providers before using Humalog?

Tell all of your healthcare providers:

  • about all of your medical conditions, including liver or kidney problems.
  • if you are pregnant or breastfeeding. Humalog has not been studi
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SOURCE Eli Lilly and Company
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