Polivy

Polatuzumab vedotin

In combination w/ bendamustine & rituximab for adult patients w/ relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant.

Recommended dose: 1.8 mg/kg IV infusion every 21 days in combination w/ bendamustine & rituximab for 6 cycles. Administer w/ bendamustine 90 mg/m² on Day 1 & 2, & rituximab 375 mg/m² on Day 1 of each cycle. Max dose: Not exceeding 240 mg/cycle. Premed w/ antihistamine & antipyretic prior to treatment.

Hypersensitivity.

Not to be administered as IV push or bolus. Discontinue in patients who develop serious infections; suspected & confirmed progressive multifocal leukoencephalopathy (PML). Infusion-related reactions; serious, severe & febrile neutropenia. Not to be administered in presence of active severe infection. Closely monitor for new or worsening neurological, cognitive, or behavioral changes suggestive of PML; tumor lysis syndrome during treatment. Monitor for infusion-related/hypersensitivity reactions during infusion & for at least 90 min following completion of initial dose; symptoms of peripheral neuropathy eg, hypo-/hyperesthesia, paresthesia, dysesthesia, neuropathic pain, burning sensation, muscle weakness, or gait disturbance; signs of bacterial, fungal, or viral infections during treatment. Reactivation of latent infections. HIV patients. Monitor CBC prior to each dose of treatment; liver enzymes & bilirubin level. Not to be given concurrently w/ live or live-attenuated vaccines. May impair ability to drive & use machines. Hepatic toxicity w/ hepatocellular injury, including elevations of transaminases &/or bilirubin. Moderate or severe hepatic impairment (total bilirubin >1.5x ULN). Renal impairment (CrCl <30 mL/min). Men w/ women of childbearing potential should use effective contraception; should not father a child during treatment & for up to 6 mth following last dose. May impair male reproductive function & fertility. Women of childbearing potential should use effective contraception during treatment & for at least 9 mth after last dose. Not recommended during pregnancy & in women of childbearing potential not using contraception. Discontinue lactation during treatment & for at least 3 mth after last dose. Childn & adolescents <18 yr. Elderly ≥65 yr.

Pneumonia, sepsis, URTI, herpes virus & cytomegalovirus infection; neutropenia, thrombocytopenia, anemia, leukopenia, lymphopenia, febrile neutropenia, pancytopenia; decreased appetite, hypokalemia, hypoalbuminemia, hypocalcemia; peripheral & peripheral sensory neuropathy, dizziness; cough, pneumonitis; diarrhea, nausea, constipation, abdominal pain, vomiting, upper abdominal pain; pruritus; arthralgia; pyrexia, fatigue, asthenia, chills; decreased wt, transaminase elevation, hypophosphatemia, increased lipase; infusion-related reactions.

Increased AUC w/ strong CYP3A4 inhibitors eg, boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Decreased exposure w/ strong CYP3A4 inducers eg, rifampicin, carbamazepine, phenobarb, phenytoin, St. John's wort (Hypericum perforatum).

Targeted Cancer Therapy

L01FX14 - polatuzumab vedotin ; Belongs to the class of other monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.

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