of peripheral neuropathy such ashypoesthesia, hyperesthesia, paresthesia, dysesthesia, neuropathic pain, burning sensation,weakness, or gait disturbance. Patients experiencing new or worsening peripheral neuropathymay require a delay, dose reduction, or discontinuation of POLIVY [see Dosage andAdministration (2.2)].
5.2 Infusion-Related Reactions
POLIVY can cause infusion-related reactions, including severe cases. Delayed infusion-relatedreactions as late as 24 hours after receiving POLIVY have occurred. With premedication, 7% ofpatients (12/173) in Study GO29365 reported infusion-related reactions after the administrationof POLIVY. The reactions were Grade 1 in 67%, Grade 2 in 25%, and Grade 3 in 8%. Symptomsincluded fever, chills, flushing, dyspnea, hypotension, and urticaria.
Administer an antihistamine and antipyretic prior to the administration of POLIVY, and monitorpatients closely throughout the infusion. If an infusion-related reaction occurs, interrupt theinfusion and institute appropriate medical management [see Dosage and Administration (2.2)].
5.3 Myelosuppression
Treatment with POLIVY can cause serious or severe myelosuppression including neutropenia,thrombocytopenia, and anemia. In patients treated with POLIVY plus BR (n = 45), 42% receivedprimary prophylaxis with granulocyte colony stimulating factor. Grade 3 or higher hematologicadverse reactions included neutropenia (42%), thrombocytopenia (40%), anemia (24%),lymphopenia (13%), and febrile neutropenia (11%) [see Adverse Reactions (6.1)]. Grade 4hematologic adverse reactions included neutropenia (24%), thrombocytopenia (16%),lymphopenia (9%), and febrile neutropenia (4.4%). Cytopenias were the most common reason
for treatment discontinuation (18% of all patients).
Monitor complete blood counts throughout treatment. Cytopenias may require a delay, dosereduction, or discontinuation of POLIVY [see Dosage and Administration (2.2)]. Considerprophylactic granulocyte colony stimulating factor administration.
5.4 Serious and Opportunistic Infections
Fatal and/or serious infections, including opportunistic infections such as sepsis, pneumonia(including Pneumocystis jiroveci and other fungal pneumonia), herpesvirus infection, andcytomegalovirus infection have occurred in patients treated with POLIVY [see AdverseReactions (6.1)].
Grade 3 or higher infections occurred in 32% (55/173) of patients treated with POLIVY.
Infection-related deaths were reported in 2.9% of patients within 90 days of last treatment.
Closely monitor patients during treatment for signs of infection. Administer prophylaxis forPneumocystis jiroveci pneumonia and herpesvirus.
5.5 Progressive Multifocal Leukoencephalopathy (PML)
PML has been reported after treatment with POLIVY (0.6%, 1/173). Monitor for new orworsening neurological, cognitive, or behavioral changes. Hold POLIVY and any concomitantchemotherapy if PML is suspected, and permanently discontinue if the diagnosis is confirmed.
5.6 Tumor Lysis Syndrome
POLIVY may cause tumor lysis syndrome. Patients with high tumor burden and rapidlyproliferative tumor may be at increased risk of tumor lysis syndrome. Monitor closely and takeappropriate measures, including tumor lysis syndrome prophylaxis.
5.7 Hepatotoxicity
Serious cases of hepatotoxicity that were consistent with hepatocellular injury, includingelevations of tra |
