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: Cytokine Release Syndrome [see Warnings and Precautions (5.1) ].
Immune Effector Cell-Associated Neurotoxicity Syndrome [see Warnings and Precautions (5.2) ].
Infections [see Warnings and Precautions (5.3) ].
Cytopenias [see Warnings and Precautions (5.4) ].
EPKINLY as monotherapy for LBCL or FL: The most common (≥ 20%) adverse reactions are CRS, injection site reactions, fatigue, musculoskeletal pain, fever, diarrhea, COVID-19, rash and abdominal pain.
The most common Grade 3 to 4 laboratory abnormalities (≥ 10%) are decreases in lymphocyte count, neutrophil count, hemoglobin, and platelets.
( 6.1 ) EPKINLY in combination with lenalidomide and rituximab for FL: The most common (≥ 20%) adverse reactions are rash, upper respiratory tract infections, fatigue, injection site reactions, constipation, diarrhea, CRS, pneumonia, COVID-19, and fever.
The most common Grade 3 to 4 laboratory abnormalities (≥ 10%) are decreased neutrophil count, lymphocyte count, and platelets.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genmab US, Inc.
at 1-855-4GENMAB (1-855-443-6622) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
5 WARNINGS AND PRECAUTIONS Infections: Can cause fatal or serious infections.
Monitor patients for signs or symptoms of infection, including opportunistic infections, and treat appropriately.
( 5.3 ) Cytopenias: Monitor complete blood cell counts during treatment.
( 5.4 ) Embryo-Fetal Toxicity: May cause fetal harm.
Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.
Like all medications, Epkinly 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: