polatuzumab vedotin




Zuellig Pharma
Concise Prescribing Info
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.
Dosage/Direction for Use
1.8 mg/kg IV infusion every 21 days in combination w/ bendamustine 90 mg/m2 on Days 1 & 2 & rituximab 375 mg/m2 on Day 1 of each cycle for 6 cycles. Max: Not to exceed 240 mg/cycle. Premed w/ antihistamine & antipyretic prior to treatment.
Hypersensitivity. Active severe infection.
Special Precautions
Discontinue use if serious, life-threatening or fatal infections develops or progressive multifocal leukoencephalopathy is confirmed. Not to be administered as IV push or bolus. Infusion-related reactions. Myelosuppression; peripheral neuropathy; HIV. Increased risk of tumor lysis syndrome. Monitor liver enzymes & bilirubin level; CBC prior to each dose. Not to be given concurrently w/ live or live-attenuated vaccines. May affect ability to drive & use machines. Hepatic toxicity. Avoid use in moderate or severe hepatic impairment. Renal impairment (CrCl <30 mL/min). May impair reproductive function & fertility in men. Women of childbearing potential should use effective contraception during & at least 9 mth after last dose. Men should not father a child during & at least 6 mth after last dose. Not recommended during pregnancy. Discontinue use during lactation & at least 3 mth after last dose. Childn & adolescents <18 yr.
Adverse Reactions
Sepsis, pneumonia, URTI; febrile neutropenia, neutropenia, thrombocytopenia, anaemia, leukopenia, lymphopenia; hypokalaemia, decreased appetite; peripheral neuropathy, dizziness; cough; diarrhoea, nausea, constipation, vomiting, abdominal pain; fatigue, pyrexia, asthenia; wt decreased; infusion-related reactions. Herpes virus & cytomegalovirus infection; pancytopenia; hypocalcaemia, hypoalbuminemia; gait disturbance, paraesthesia, hypoaesthesia; blurred vision; pneumonitis; upper abdominal pain; pruritus; arthralgia; chills; elevated transaminase, increased lipase, hypophosphataemia.
Drug Interactions
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).
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01FX14 - polatuzumab vedotin ; Belongs to the class of other monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.
Polivy powd for infusion 140 mg
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