You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at (888) 835-2555.
POLIVY is a CD79b-directed antibody-drug conjugate indicated:
Warnings and Precautions
Peripheral Neuropathy: Monitor patients for peripheral neuropathy and modify or discontinue dose accordingly.
Infusion-Related Reactions: Premedicate with an antihistamine and an antipyretic. Monitor patients closely during infusions. Interrupt or discontinue infusion if reactions occur.
Myelosuppression: Monitor complete blood counts. Manage using dose delays or reductions and growth factor support. Monitor for signs of infection.
Serious and Opportunistic Infections: Closely monitor patients for signs of bacterial, fungal, or viral infections.
Progressive Multifocal Leukoencephalopathy (PML): Monitor patients for new or worsening neurological, cognitive, or behavioral changes suggestive of PML.
Tumor Lysis Syndrome: Closely monitor patients with high tumor burden or rapidly proliferative tumors.
Hepatotoxicity: Monitor liver enzymes and bilirubin.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 3 months after the last dose.
The Most Common Adverse Reactions
The most common adverse reactions (≥20%), excluding laboratory abnormalities, in patients with previously untreated DLBCL treated with POLIVY in combination with R-CHP are peripheral neuropathy, nausea, fatigue, diarrhea, constipation, alopecia, and mucositis. The most common Grade 3 to 4 laboratory abnormalities (≥20%) are lymphopenia and neutropenia.
The most common adverse reactions (≥20%) in patients with relapsed or refractory DLBCL treated with POLIVY in combination with BR are neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, pyrexia, decreased appetite, and pneumonia.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see the full Prescribing Information for additional Important Safety Information.