HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
POLIVY safely and effectively. See full prescribing information for
POLIVY.
POLIVY™ (polatuzumab vedotin-piiq) for injection, for intravenous use
Initial U.S. Approval: 2019
INDICATIONS AND USAGE
POLIVY is a CD79b-directed antibody–drug conjugate indicated incombination with bendamustine and a rituximab product for the treatment ofadult patients with relapsed or refractory diffuse large B-cell lymphoma, nototherwise specified, after at least two prior therapies. (1)
Accelerated approval was granted for this indication based on completeresponse rate. Continued approval for this indication may be contingentupon verification and description of clinical benefit in a confirmatorytrial.
DOSAGE AND ADMINISTRATION
The recommended dose of POLIVY is 1.8 mg/kg as an intravenousinfusion over 90 minutes every 21 days for 6 cycles in combination withbendamustine and a rituximab product. Subsequent infusions may beadministered over 30 minutes if the previous infusion is tolerated. (2)
Premedicate with an antihistamine and antipyretic before POLIVY. (2)
See Full Prescribing Information for instructions on preparation andadministration. (2.4)
DOSAGE FORMS AND STRENGTHS
For injection: 140 mg of polatuzumab vedotin-piiq as a lyophilized powder ina single-dose vial. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Peripheral Neuropathy: Monitor patients for peripheral neuropathy andmodify or discontinue dose accordingly. (5.1)
Infusion-Related Reactions: Premedicate with an antihistamine andantipyretic. Monitor patients closely during infusions. Interrupt ordiscontinue infusion for reactions. (5.2)
Myelosuppression: Monitor complete blood counts. Manage using dosedelays or reductions and growth factor support. Monitor for signs ofinfection. (5.3)
Serious and Opportunistic Infections: Closely monitor patients for signs ofbacterial, fungal, or viral infections. (5.4)
Progressive Multifocal Leukoencephalopathy (PML): Monitor patients fornew or worsening neurological, cognitive, or behavioral changessuggestive of PML. (5.5)
Tumor Lysis Syndrome: Closely monitor patients with high tumor burdenor rapidly proliferative tumors. (5.6)
Hepatotoxicity: Monitor liver enzymes and bilirubin. (5.7)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females ofreproductive potential of the potential risk to a fetus and to use effectivecontraception during treatment and for 3 months after the last dose. (5.8)
ADVERSE REACTIONS
The most common adverse reactions (≥20%) included neutropenia,thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, pyrexia,decreased appetite, and pneumonia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Genentech at1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTION