Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity and Other Administration Reactions [see Warnings and Precautions (5.1) ] .
Cardiac Toxicity in Patients with Light Chain (AL) Amyloidosis [see Warnings and Precautions (5.2) ] .
Infections [see Warnings and Precautions (5.3) ] .
Neutropenia [see Warnings and Precautions (5.4) ] .
Thrombocytopenia [see Warnings and Precautions (5.5) ] .
The most common adverse reactions (≥20%) in patients with multiple myeloma eligible for autologous stem cell transplant who received DARZALEX FASPRO-VRd are peripheral neuropathy, fatigue, upper respiratory infection, constipation, musculoskeletal pain, insomnia, rash, diarrhea, edema, and pyrexia.
( 6.1 ) The most common adverse reactions (≥20%) in patients with multiple myeloma who were ineligible for autologous stem cell transplant who received DARZALEX FASPRO-VRd are upper respiratory tract infection, sensory neuropathy, musculoskeletal pain, diarrhea, fatigue, edema, rash, motor dysfunction, COVID-19, constipation, sleep disorder, cough, pneumonia, renal impairment, dizziness, nausea, urinary tract infection, pyrexia, abdominal pain, dyspnea, decreased appetite, and bruising.
( 6.1 ) The most common adverse reaction (≥20%) in patients with multiple myeloma who received DARZALEX FASPRO monotherapy is upper respiratory tract infection.
( 6.1 ) The most common adverse reactions (≥20%) in patients with multiple myeloma who received DARZALEX FASPRO-VMP are upper respiratory tract infection, constipation, nausea, fatigue, pyrexia, peripheral sensory neuropathy, diarrhea, cough, insomnia, vomiting, and back pain.
( 6.1 ) The most common adverse reactions (≥20%) in patients with multiple myeloma who received DARZALEX FASPRO-Rd are fatigue, diarrhea, upper respiratory tract infection, muscle spasms, constipation, pyrexia, pneumonia, and dyspnea.
5 WARNINGS AND PRECAUTIONS Hypersensitivity and Other Administration Reactions : Permanently discontinue DARZALEX FASPRO for life-threatening reactions.
( 5.1 ) Cardiac Toxicity in Patients with Light Chain (AL) Amyloidosis : Monitor patients with cardiac involvement more frequently for cardiac adverse reactions and administer supportive care as appropriate.
( 5.2 ) Infections : DARZALEX FASPRO can cause serious and fatal infections.
Monitor patients for signs and symptoms of infection and treat appropriately.
( 5.3 ) Neutropenia : Monitor complete blood cell counts periodically during treatment.
Like all medications, Darzalex Faspro can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: