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 adverse reactions are discussed elsewhere in labeling: • Cytokine Release Syndrome [see Warnings and Precautions (5.1) ] .
• Neurologic Toxicity, Including ICANS [see Warnings and Precautions (5.2) ] .
• Infections [see Warnings and Precautions (5.4) ] .
• Neutropenia [see Warnings and Precautions (5.5) ] .
• Hepatotoxicity [see Warnings and Precautions (5.6) ] .
Most common adverse reactions (incidence ≥20%) are CRS, fatigue, injection site reaction, diarrhea, upper respiratory tract infection, musculoskeletal pain, pneumonia, decreased appetite, rash, cough, nausea, and pyrexia.
The most common Grade 3 to 4 laboratory abnormalities (≥30%) are decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased white blood cells, and decreased platelets.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc.
at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
5 WARNINGS AND PRECAUTIONS • Infections : Can cause severe, life-threatening, or fatal infections.
Monitor patients for signs and symptoms of infection and treat appropriately.
Do not initiate treatment in patients with active infections.
( 5.4 ) • Neutropenia : Monitor complete blood cell counts at baseline and periodically during treatment.
( 5.5 ) • Hepatotoxicity : Can cause elevated ALT, AST, and bilirubin.
Like all medications, Elrexfio 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: