Revlimid Receives New Indication
February 22, 2017 – The U.S. Food and Drug Administration (FDA) approved Revlimid® (lenalidomide), an oral immunomodulatory drug with a new indication. Revlimid is manufactured by Celgene. In addition to its previous approvals for treating mantle cell lymphoma (MCL), multiple myeloma (MM) and anemia related to transfusions for myelodysplastic syndromes (MDS), Revlimid now is approved for maintenance treatment of patients who have had autologous hematopoietic stem cell transplants (auto-HSCT) for MM. Recommended initial dosing is 10mg daily for 84 days. The dose then is raised to 15mg daily, if the patient can tolerate the higher dose. In clinical studies, progression-free survival ranged from about 1.5 years to about 3.8 years longer for auto-HSCT patients treated with Revlimid than for untreated patients. A Medication Guide and boxed warnings on Revlimid’s labeling caution that using it during pregnancy can cause birth defects or death for the fetus, and that it increases the risks of blood clots, heart attacks, strokes and/or blood abnormalities. Its use is limited through the Revlimid Risk Evaluation and Mitigation Strategy (REMS) Program, which requires patients, pharmacies and prescribers to be authorized before using, dispensing or prescribing it.
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.