Polivy

Polivy

polatuzumab vedotin

Manufacturer:

Roche

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Polatuzumab vedotin
Indications/Uses
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 Day 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.
Contraindications
Hypersensitivity. Active severe infection.
Special Precautions
Discontinue use if serious, life-threatening or fatal infections develops. Infusion-related reactions. Myelosuppression; peripheral neuropathy; HIV; progressive multifocal leukoencephalopathy. Increased risk of tumor lysis syndrome. Monitor liver enzymes & bilirubin level; complete blood counts prior to each dose. Not to be given concurrently w/ live or live-attenuated vaccines. Hepatic toxicity. Avoid use in moderate or severe hepatic impairment. Renal impairment (CrCl <30 mL/min). May affect ability to drive & use machines. Women of childbearing potential should use effective contraception during & at least 9 mth after last dose. Men should not father a child during & for up to 6 mth after last dose. May impair reproductive function & fertility in men. Not recommended during pregnancy. Discontinue use during lactation. Childn & adolescents <18 yr. Elderly ≥65 yr.
Adverse Reactions
Pneumonia, herpes virus & upper resp tract infection; febrile neutropenia, neutropenia, thrombocytopenia, anaemia, leukopenia, lymphopenia; hypokalaemia, hypocalcaemia, hypoalbuminemia, decreased appetite; peripheral & sensory neuropathy, dizziness; cough; diarrhoea, nausea, constipation, vomiting, upper abdominal pain; pruritus; fatigue, pyrexia, asthenia, chills; decreased wt; infusion-related reactions. Sepsis, cytomegalovirus infection; pancytopenia; gait disturbance, paraesthesia, hypoaesthesia; blurred vision; pneumonitis; arthralgia; 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).
ATC Classification
L01XC37 - polatuzumab vedotin ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Polivy powd for infusion 140 mg
Packing/Price
1's
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