Polivy

In combination w/ rituximab, cyclophosphamide, doxorubicin, & prednisone (R-CHP) for the treatment of previously untreated diffuse large B-cell lymphoma (DLBCL) in adults. In combination w/ bendamustine & rituximab for the treatment of relapsed/refractory DLBCL in adults 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.

Must not be administered 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 (PML). Monitor CBC prior to each Polivy dose. Patients experiencing new or worsening PN may require a delay, dose reduction, or discontinuation of Polivy. Consider anti-infective prophylaxis throughout treatment. Should not be administered in the presence of an active severe infection. Has not been evaluated in HIV patients. Should not be given concurrently w/ live or live-attenuated vaccines. Monitor closely for new or worsening neurological, cognitive, or behavioural changes suggestive of PML. Increased risk of tumour lysis syndrome in patients w/ high tumour burden & rapidly proliferative tumour. Can cause infusion-related reactions (IRR). Premedicate w/ antihistamine & antipyretic prior to Polivy administration, & monitor closely throughout infusion. Risk of hepatic toxicity. Monitor liver enzymes & bilirubin level. Minor influence on the ability to drive & use machines. Limited data in patients w/ renal impairment (CrCl <30 mL/min). Avoid use in patients w/ moderate or severe hepatic impairment. Women of childbearing potential should use effective contraception during treatment & for at least 9 mth after the last dose. Male patients w/ female partners of childbearing potential should use effective contraception during treatment & for at least 6 mth after the last dose. Can be harmful to the foetus when administered to a pregnant woman. Not recommended during pregnancy & in women of childbearing potential not using contraception unless potential benefit for the mother outweighs potential risk to the foetus. Women should discontinue breastfeeding during treatment & for at least 3 mth after the last dose. May impair male reproductive function & fertility. Safety & efficacy in childn & adolescents <18 yr have not been established.

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 transaminases & lipase, hypophosphataemia.

Strong CYP3A4 & P-gp inhibitors (eg, ketoconazole) may increase AUC of unconjugated monomethyl auristatin E (MMAE). 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). Strong CYP3A4 inducers (eg, rifampicin, carbamazepine, phenobarb, phenytoin, St. John's wort) may decrease exposure of unconjugated MMAE.

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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