March 10, 2016 – The U.S. Food and Drug Administration granted approval to Spectrum Pharmaceutical’s Evomela (melphalan) for injection, indicated to provide palliative care for multiple myeloma patients unable to take oral medication, as well as in high doses, as the first drug for pre conditioning before a progenitor (stem) cell transplant for multiple myeloma patients. The drug was first approved in the U.S. in 1964 as Alkeran (by GlaxoSmithKline) an alkylator which interrupts cell division, in oral tablet and injectable formulations.
Evomela is not interchangeable with other injectable melphalan products. An advantage of Evomela is it can be kept at room temperature for 4 to 5 hours or refrigerated for up to 24 hours without losing effectiveness unlike Alkeran injection which needs to be used immediately after it is reconstituted. Also, it is recommended that Melphalan be prescribed and supervised only by physicians proficient in using it, due to its affiliation to severe, potentially life-threatening allergic reactions in approximately 2% of the patients on the drug. Also, all forms of Melphalan carry boxed warnings that it may interfere seriously with production of blood cells in bone marrow, possibly resulting in leukemia, infections or excessive bleeding. There is currently no information on pricing or launch dates for Evomela.
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.