Expanded Indication Approved for Kyprolis
July 24, 2015 – The U.S. Food and Drug Administration (FDA) approved an additional indication for Kyprolis (carfilzomab-Amgen) for injection. Along with dexamethasone and Revlimid (lenalidomide), Kyprolis was approved to treat multiple myeloma patients who have tried up to three previous therapies. Kyprolis was first approved in July 2012 as a monotherapy for patients who have received at least two prior therapies, including bortezomib and an immunomodulatory agent for multiple myeloma, but whose disease has worsened within 60 days or less after completion of the last therapy. Administered by a healthcare professional via intravenous injection (IV), Kyprolis will be given in doses based on the patient’s body surface area and synchronized with doses of dexamethasone and Revlimid on four-week treatment cycles.
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.