New Dosing Approved for Darzalex
February 8, 2019 – The U.S. FDA has approved a new dosing regimen for Darzalex® (daratumumab), manufactured by Janssen. The product is indicated for use alone or in combination with other drugs to treat multiple myeloma.
Originally approved in 2015, Darzalex targets multiple myeloma cancer cells and aids the body’s immune system in identifying and destroying them. The new FDA approval is for a split dosing regimen that allows the first treatment to be divided across two separate infusions. In clinical studies, administering the first treatment as a split infusion had a safety and efficacy profile comparable to a single infusion. The recommended total dose is 16mg/kg of actual body weight.
Because infusion is begun slowly during a patient’s first treatment with Darzalex, due to the potential for side effects, the initial treatment can take up to 20 hours to complete if given in a single sitting. Dividing the treatment into a split infusion that can be given on two consecutive days reduces the stress patients may experience. Subsequent infusions will not be split, but may be administered at a faster infusion rate than the initial treatment.