Repatha Pushtronex System Approved
July 11, 2016 – The U.S. FDA approved Repatha® (evolocumab) Pushtronex™ system to deliver a single-dose of Repatha once a month. Repatha, manufactured by Amgen, is a PCSK9 inhibitor. The Pushtronex system is a hands-free, on-body infuser device designed to subcutaneously administer 420mg of Repatha as a single dose over nine minutes. Prior to the Pushtronex system, the single monthly dose required injection with three 140mg syringes as Repatha was only available as 140mg single-use prefilled syringes and SureClick® autoinjectors. Repatha is also approved with a dosing schedule of 140mg subcutaneously every two weeks. The Repatha Pushtronex system in anticipated to be launched by Amgen in August 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.