Leukemias, lymphomas, and other hematologic cancers:
Indications for: POLIVY
In combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adults who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater. In combination with bendamustine and a rituximab product for the treatment of relapsed or refractory DLBCL, NOS, after at least 2 prior therapies.
Adult Dosage:
Premedicate 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. Previously untreated DLBCL, NOS, or HGBL: administer with R-CHP in any order on Day 1 after administering prednisone on Days 1–5 of each cycle. Relapsed or refractory DLBCL: administer with bendamustine and a rituximab product in any order on Day 1 of each cycle. Dose modifications for adverse reactions: see full labeling.
Children Dosage:
Not established.
POLIVY 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. For neutropenia: administer prophylactic G-CSF in those on Polivy plus R-CHP; consider prophylactic G-CSF in those on Polivy plus bendamustine/rituximab product. 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 Classification:
CD79b-directed antibody-drug conjugate.
POLIVY Interactions:
May be potentiated by strong CYP3A4 inhibitors; monitor for toxicity. May be antagonized by strong CYP3A4 inducers.
Adverse Reactions:
Peripheral neuropathy, nausea, fatigue, diarrhea, constipation, alopecia, mucositis, thrombocytopenia, pyrexia, decreased appetite, pneumonia, Grade 3/4 lab abnormalities (lymphopenia, neutropenia, hyperuricemia, anemia); infusion-related reactions, infection, tumor lysis syndrome, PML, hepatotoxicity.
Drug Elimination:
Median acMMAE half-life: 12.2 days (4.5–36.7 days). Median unconjugated MMAE half-life: 3.74 days (1.58–10.1 days).
Clearance: 0.9 L/day (in patients with B-cell malignancies).
Generic Drug Availability:
NO
How Supplied:
Single-dose vial—1
