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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.
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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.
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Overdosage
View Polivy overdosage for action to be taken in the event of an overdose.
Contraindications
Hypersensitivity. Active severe infection.
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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.
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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.
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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).
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Caution For Usage
For caution against possible variation of physical aspect of medicine... Click to view Polivy detailed prescribing information
Storage
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Description
View Polivy description for details of the chemical structure and excipients (inactive components).
Action
View Polivy mechanism of action for pharmacodynamics and pharmacokinetics details.
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.
Presentation/Packing
Form
Polivy powd for infusion 140 mg
Packing/Price
1's
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