New Strength for Auvi-Q
November 9, 2017 – The U.S. FDA has approved Auvi-Q® (epinephrine injection) 0.1mg, manufactured by Kaléo, to treat pediatric patients weighting between 7.5kg (16.5lbs) and 25kg (33lbs) who are at risk for or have a history of anaphylaxis, a severe, life-threatening allergic reaction. Auvi-Q 0.1mg is the first epinephrine auto-injector approved for this indication.
The auto-injector for Auvi-Q 0.1mg is specifically designed for use in small children, with a shorter needle that retracts automatically after use to prevent accidental sticks. It also features visual and audio prompts to guide the user through each step of administration. The new 0.1mg auto-injector will be available in packages that contain two pre-filled devices, and one inactive practice device. Each prescription fill of Auvi-Q auto-injectors is accompanied by detailed instructions. Auvi-Q is intended for immediate administration in an emergency, and should only be injected into the outer thigh.
Pricing and launch plans for Auvi-Q 0.1mg have not yet been announced.
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 U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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 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.