Humulin U-500 KwikPen Approved
January 20, 2016 – The U.S. Food and Drug Administration (FDA) approved a KwikPen version of Humulin R (insulin human injection) U-500 manufactured by Eli Lilly and Company. Humulin U-500 is used by patients with diabetes requiring high doses of insulin (more than 200 units per day) to control blood sugar levels. Unlike other insulins that are not as concentrated, Humulin R U-500 contains 500 units of insulin per milliliter (mL). Previously Humulin U-500 has been available in 20mL vials, this insulin has not been packaged in a pen device until now. Each disposable, pre-filled U-500 KwikPen contains 1,500 units of insulin. The pen device is the same size as KwikPens for other strengths and types of Lilly insulin, but it is the only one that is turquoise in color. Lilly plans to launch Humulin R U-500 KwikPens in April, 2016.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan