Expanded Indication for Darzalex
November 21, 2016 - The U.S. FDA approved two drug regimens that include Janssen Biotech’s Darzalex® (daratumumab) injection for intravenous use. For treating patients who have multiple myeloma that has been treated once previously, Darzalex now is indicated along with dexamethasone and Revlimid® (lenalidomide – Celgene Corporation) or Velcade® (bortezomib – Millennium Pharmaceuticals). Darzalex is a monoclonal antibody with specific activity against CD38, a protein on the surface of multiple myeloma cells. Originally, Darzalex was FDA approved in November 2015 to be used by itself after multiple-myeloma patients had tried at least three other treatments, including an immunomodulator, such as Revlimid, and a proteasome inhibitor, such as Velcade. For use with Revlimid, the recommended dosing schedule for Darzalex is once a week for eight weeks, then once every two weeks until week 24 and then once every four weeks. With Velcade, the schedule is Darzalex once every week for nine weeks, once every three weeks between weeks 10 and 24 and then once every four weeks. Darzalex continues to be administered by a healthcare provider until it stops working. Although infusion rates may vary, the recommended dose for all Darzalex indications is 16mg/Kg of the patient’s body weight.
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 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.