Polivy

Polatuzumab vedotin

In combination w/ rituximab, cyclophosphamide, doxorubicin, & prednisone (R-CHP) for the treatment of previously untreated diffuse large B-cell lymphoma (DLBCL) in adult patients. In combination w/ bendamustine & rituximab for the treatment of relapsed/refractory DLBCL in adult patients who are not candidates for haematopoietic stem cell transplant.

Administer initial Polivy dose as 90-min IV infusion. If prior infusion is well tolerated, administer subsequent dose as 30-min infusion. Previously untreated patient 1.8 mg/kg IV infusion every 21 days in combination w/ R-CHP for 6 cycles. Relapsed/refractory patient 1.8 mg/kg IV infusion every 21 days in combination w/ bendamustine & rituximab for 6 cycles. Max: 240 mg/cycle.

Hypersensitivity. Active severe infections.

Do not administer as IV push or bolus. Reports of serious & severe neutropenia & febrile neutropenia; peripheral neuropathy (PN); infections, including opportunistic infections eg, pneumonia (including Pneumocystis jirovecii & other fungal pneumonia), bacteraemia, sepsis, herpes infection, & cytomegalovirus infection; reactivation of latent infection; progressive multifocal leukoencephalopathy. Monitor complete blood counts prior to each Polivy dose. Consider anti-infective prophylaxis throughout treatment. Should not be administered in the presence of an active severe infection. Should not be concurrently given w/ live or live-attenuated vaccines. Increased risk of tumour lysis syndrome in patients w/ high tumour burden & rapidly proliferative tumour. Can cause infusion-related reactions (IRR). Pre-medicate w/ antihistamine & antipyretic prior to treatment administration. Risk of hepatic toxicity. Monitor liver enzymes & bilirubin level. Minor influence on the ability to drive & use machines. HIV patients. Patients w/ renal impairment (CrCl <30 mL/min). Avoid use in patients w/ moderate or severe hepatic impairment. Can be harmful to the foetus when administered to a pregnant woman. Women of childbearing potential should be advised to use effective contraception during treatment & for at least 9 mth after the last dose. Male patients w/ female partners of childbearing potential should be advised to use effective contraception during treatment & for at least 6 mth after the last dose. May impair male reproductive function & fertility. Pregnancy. Discontinue breastfeeding during therapy & for at least 3 mth after the last dose. Elderly. Childn & adolescents <18 yr.

Pneumonia, URTI; febrile neutropenia, neutropenia, thrombocytopenia, anaemia, leukopenia; hypokalaemia, decreased appetite; PN; cough; diarrhoea, nausea, constipation, vomiting, mucositis, abdominal pain; alopecia; pyrexia, fatigue, asthenia; decreased wt; IRR. Sepsis, herpes virus infection, cytomegalovirus infection, UTI; lymphopenia, pancytopenia; hypocalcaemia, hypoalbuminemia; dizziness; pneumonitis, dyspnoea; pruritus, skin infections, rash, dry skin; arthralgia, myalgia; peripheral edema, chills; increased transaminase & lipase, hypophosphataemia.

Increased AUC of unconjugated monomethyl auristatin E (MMAE) w/ strong CYP3A4 & P-gp inhibitors (eg, ketoconazole). Closely monitor for signs of toxicities when co-administered w/ strong CYP3A4 inhibitors (eg, boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole). Decreased exposure of unconjugated MMAE 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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