Polivy Generic Name & Formulations
Legal Class
Rx
General Description
Polatuzumab vedotin-piiq 140mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free.
Pharmacological Class
CD79b-directed antibody-drug conjugate.
How Supplied
Single-dose vial—1
Manufacturer
Generic Availability
NO
Polivy Indications
Indications
In combination with bendamustine and a rituximab product for the treatment of relapsed or refractory diffuse large B-cell lymphoma after at least 2 prior therapies.
Polivy Dosage and Administration
Adult
Pre-medicate with antihistamine and antipyretic ≥30–60mins prior to dosing. Give by IV infusion. Initially 1.8mg/kg over 90mins every 21 days for 6 cycles; if tolerated, may give subsequent doses over 30mins. Dose modifications for adverse reactions: see full labeling.
Children
Not established.
Polivy Contraindications
Not Applicable
Polivy Boxed Warnings
Not Applicable
Polivy Warnings/Precautions
Warnings/Precautions
Monitor for peripheral neuropathy; interrupt, reduce dose, or discontinue based on severity if occurs. Monitor CBCs during treatment; interrupt, reduce dose, or discontinue if cytopenias occur; consider granulocyte colony stimulating factor prophylaxis. Monitor closely for tumor lysis syndrome, serious/fatal infections (eg, sepsis, pneumonia, herpes, CMV); give prophylaxis for Pneumocystis jiroveci pneumonia and herpes virus. Monitor closely for infusion-related reactions; interrupt and treat if occurs; permanently discontinue based on severity. Monitor for progressive multifocal leukoencephalopathy (PML); withhold if suspected and permanently discontinue if confirmed. Risk of hepatotoxicity; monitor LFTs. Moderate to severe hepatic impairment: avoid. Embryo-fetal toxicity. Pregnancy: avoid; exclude status prior to initiation. Advise use of effective contraception during and for ≥3 months (females) and ≥5 months (males w. female partners) after last dose. Nursing mothers: not recommended (during and for ≥2 months after last dose).
Polivy Pharmacokinetics
See Literature
Polivy Interactions
Interactions
May be potentiated by strong CYP3A4 inhibitors; monitor for toxicity. May be antagonized by strong CYP3A4 inducers.
Polivy Adverse Reactions
Adverse Reactions
Neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, pyrexia, decreased appetite, pneumonia; infusion-related reactions, infection, tumor lysis syndrome, PML, hepatotoxicity.
Polivy Clinical Trials
See Literature
Polivy Note
Not Applicable
Polivy Patient Counseling
See Literature