New Strength for Humalog KwikPens
May 27, 2015 - The U.S. Food and Drug Administration (FDA) approved Humalog® U-200 KwikPen®, manufactured by Ely Lilly. Humalog U-200 is a more concentrated formulation of Humalog (insulin lispro 200 units/mL) which is a rapid-acting insulin intended to be given about 15 minutes before a meal or immediately after eating. It is indicated to improve blood sugar control for patients with either type 1 diabetes or type 2 diabetes.
Humalog U-200 is currently available in 3mL KwikPens, unlike Humalog U-100 (100 units/mL) which comes in 10mL vials, 3mL cartridges and 3mL prefilled KwikPen devices. Humalog U-200 cannot be given intravenously, through a syringe or in an insulin pump and it should not be mixed with other insulins. Humalog U-200 concentrates twice the amount of insulin into the same size KwikPen cartridge; therefore doses can be smaller in volume than with Humalog U-100. Insulin pen devices should never be used by more than one patient and needles should be discarded after every injection.
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. All trademarks are the property of their respective owners.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.