POLATUZUMAB VEDOTIN

Other

Brand names: POLIVY

Intravenous

Mechanism of Action

12.1 Mechanism of Action 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.

Indications

1 INDICATIONS AND USAGE 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)

NOS

after at least two prior therapies. ( 1.2 ) 1.1 Previously Untreated DLBCL

Contraindications

• 4 CONTRAINDICATIONS None. None. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Peripheral Neuropathy: Monitor patients for peripheral neuropathy and modify or discontinue dose accordingly
3 ) Serious and Opportunistic Infections: Closely monitor patients for signs of bacterial, fungal, or viral infections
Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 3 months after the last dose
3 Myelosuppression Treatment with POLIVY can cause serious or severe myelosuppression, including neutropenia, thrombocytopenia, and anemia

Known Side Effects

2 documented side effects by frequency

Drug Not Working

1-10%

Fever

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Intravenous