ASH Clinical News July 2017 V2 - Page 11

DARZALEX ® + Rd or Vd after first relapse in multiple myeloma DISCOVER DARZALEX ® (daratumumab) the first and only CD38-directed monoclonal antibody (mAb) 1 Indication DARZALEX ® (daratumumab) is indicated in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. Rd=lenalidomide and dexamethasone; Vd=bortezomib and dexamethasone. Important Safety Information Warnings and precautions include: infusion reactions, interference with serological testing, neutropenia, thrombocytopenia, and interference with determination of complete response. In patients who received DARZALEX ® in combination with lenalidomide and dexamethasone, the most frequently reported adverse reactions (incidence ≥20%) were: neutropenia (92%), thrombocytopenia (73%), upper respiratory tract infection (65%), infusion reactions (48%), diarrhea (43%), fatigue (35%), cough (30%), muscle spasms (26%), nausea (24%), dyspnea (21%) and pyrexia (20%). The overall incidence of serious adverse reactions was 49%. Serious adverse reactions were: pneumonia (12%), upper respiratory tract infection (7%), influenza (3%) and pyrexia (3%). In patients who received DARZALEX ® in combination with bortezomib and dexamethasone, the most frequently reported adverse reactions (incidence ≥20%) were: thrombocytopenia (90%), neutropenia (58%), peripheral sensory neuropathy (47%), infusion reactions (45%), upper respiratory tract infection (44%), diarrhea (32%), cough (27%), peripheral edema (22%), and dyspnea (21%). The overall incidence of serious adverse reactions was 42%. Serious adverse reactions were: upper respiratory tract infection (5%), diarrhea (2%) and atrial fibrillation (2%). Please see Important Safety Information and brief summary of full Prescribing Information on following pages.