New Indication for Revlimid
The U.S. Food and Drug Administration (FDA) approved Revlimid (lenalidomide capsules - Celgene) for a new indication. Revlimid can now be used in combinations with dexamethasone as first-line treatment for patients diagnosed with, but not yet treated for, multiple myeloma.
Revlimid was originally indicated for anemia associated with myelodysplastic syndromes that have specific genetic mutations and to treat mantle-cell lymphoma that has relapsed and multiple myeloma that already has been treated with other drugs.
Dosing of Revlimid for multiple myeloma is on 28-day cycles of 25mg once a day for 21 days along with 40mg of dexamethasone on days 1, 8, 15 and 22, and then no treatment. Dosing cycles continue until the disease progresses or the patient can no longer tolerate treatment. Progression-free survival in clinical trials averaged approximately one year longer for patients using Revlimid than for patients receiving a standard treatment regimen of melphalan.
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.