Posted from: Sunday, December 11, 2016 - 03:50 PM - Present

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.


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Last Updated Wednesday, October 16, 2019 - 09:23 PM.