Polatuzumab vedotin

POLIVY is a CD79b-directed antibody and microtubule inhibitor conjugate indicated: in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients 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 adult patients with relapsed or refractory DLBCL, NOS, after at least two prior therapies.

Polatuzumab vedotin-piiq is a CD79b-directed antibody-drug conjugate with activity against dividing B cells. The small molecule, MMAE, is an anti-mitotic agent covalently attached to the antibody via a cleavable linker. The monoclonal antibody binds to CD79b, a B-cell specific surface protein, which is a component of the B-cell receptor. Upon binding CD79b, polatuzumab vedotin-piiq is internalized, and the linker is cleaved by lysosomal proteases to enable intracellular delivery of MMAE. MMAE binds to microtubules and kills dividing cells by inhibiting cell division and inducing apoptosis.

The recommended dose of POLIVY is 1.8 mg/kg as an intravenous infusion every 21 days for 6 cycles. Administer the initial POLIVY dose over 90 minutes. Subsequent infusions may be administered over 30 minutes if the previous infusion is tolerated. Premedicate with an antihistamine and antipyretic before POLIVY. See Full Prescribing Information for instructions on preparation and administration.

None. None.

Peripheral Neuropathy: Monitor patients for peripheral neuropathy and modify or discontinue dose accordingly. Infusion-Related Reactions: Premedicate with an antihistamine and antipyretic. Monitor patients closely during infusions. Interrupt or discontinue infusion for reactions. 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.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the label: Peripheral Neuropathy Infusion-Related Reactions Myelosuppression Serious and Opportunistic Infections Progressive Multifocal Leukoencephalopathy Tumor Lysis Syndrome Hepatotoxicity Infusion Site Extravasation Injury The most common adverse reactions (≥20%) in patients with large B-cell lymphoma treated with POLIVY in combination with R-CHP, excluding laboratory abnormalities, are peripheral neuropathy, nausea, fatigue, diarrhea, constipation, alopecia, and mucositis. Grade 3 to 4 laboratory abnormalities (≥10%) are lymphopenia, neutropenia, hyperuricemia, and anemia.

Concomitant use of strong CYP3A inhibitors or inducers has the potential to affect the exposure to unconjugated monomethyl auristatin E (MMAE).

Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not shake.