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Polivy 140mg Injection
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Indications & Clinical Uses
- Polivy 140 mg (polatuzumab vedotin-piiq in the US) is an antibody-drug conjugate that delivers the cytotoxic agent monomethyl auristatin E (MMAE).
- It is supplied as a lyophilised powder in a single-dose vial (a 30 mg vial also exists) and is given only by intravenous infusion in a hospital or clinic by a healthcare provider.
- Under the US label it is used with rituximab, cyclophosphamide, doxorubicin and prednisone for previously untreated diffuse large B-cell lymphoma (DLBCL) not otherwise specified or high-grade B-cell lymphoma with an IPI score of 2 or more, and with bendamustine and rituximab for relapsed or refractory DLBCL not otherwise specified after at least two prior therapies.
- The dose is 1.8 mg/kg every 21 days for 6 cycles.
- Genentech (a Roche Group member) holds the US label; the EU label was not reviewed.
Side Effects
- In the POLARIX study (with R-CHP) the most common reactions were peripheral neuropathy (53%), nausea (42%), fatigue (37%), diarrhoea (31%), constipation (29%), hair loss (24%) and mouth sores or mucositis (22%).
- In the relapsed study with bendamustine and rituximab, common reactions included low neutrophils and low platelets (49% each), anaemia (47%), neuropathy (40%), tiredness (40%), diarrhoea (38%), fever (33%), reduced appetite (27%) and pneumonia (22%).
- Serious effects include infusion reactions (13% with premedication), serious infections, bone marrow suppression, progressive multifocal leukoencephalopathy (PML), tumour lysis syndrome, liver toxicity and drug leakage at the infusion site.
- Polivy has no boxed warning.
- Report numbness, tingling, weakness, fever, chills, breathing difficulty, rash or new confusion promptly.
Precautions & Warnings
- Polivy can cause fetal harm.
- Women who can become pregnant should use effective contraception during treatment and for 3 months after the last dose; men with female partners should use effective contraception during treatment and for 5 months after.
- Do not breastfeed during treatment and for 2 months after the final dose.
- Peripheral neuropathy is cumulative, so healthcare providers monitor symptoms and adjust doses.
- Blood counts and liver enzymes are monitored, and prophylaxis against Pneumocystis pneumonia and herpesvirus infection is given.
- Premedication with an antihistamine and an antipyretic at least 30 minutes beforehand reduces infusion reactions.
- The infusion site is watched for extravasation.
- PML is suspected with new neurological, cognitive or behavioural changes, and treatment is held.
- There are no contraindications listed in the US label.
- Polivy comes in 30 mg and 140 mg vials and is dosed by body weight.
Avoid Interactions
- Things that can increase toxicity: strong CYP3A inhibitors (for example ketoconazole) can raise levels of unconjugated MMAE, the toxic component of Polivy; ketoconazole was predicted to increase MMAE exposure by about 45%, so patients are monitored for signs of toxicity.
- Things that can reduce effect: strong CYP3A inducers (for example rifampin) can lower MMAE exposure, with rifampin predicted to reduce it by about 63%.
- No significant interaction is predicted with bendamustine or rituximab given together with Polivy.
- Avoid pregnancy and breastfeeding as described under precautions.
- Tell your healthcare team about all prescription and over-the-counter medicines, herbal products and supplements you take before each cycle.
References
Frequently Asked Questions
Polivy (polatuzumab vedotin) treats diffuse large B-cell lymphoma. In the US label it is used with R-CHP chemotherapy for previously untreated disease with an IPI score of 2 or more, and with bendamustine and rituximab for relapsed or refractory disease after at least two earlier treatments.
Polivy (polatuzumab vedotin) is given as an intravenous infusion of 1.8 mg/kg every 21 days for 6 cycles. The first infusion runs over 90 minutes. If it is tolerated, later infusions can run over 30 minutes. A healthcare provider gives it in a clinic or hospital.
The most common Polivy side effects are numbness or tingling (peripheral neuropathy, 53%), nausea, tiredness, diarrhoea, constipation, hair loss and mouth sores. Serious risks include infusion reactions, infections, low blood counts, PML and liver problems. Polivy has no boxed warning. Report fever, chills or new confusion at once.
Avoid pregnancy and breastfeeding while on Polivy (polatuzumab vedotin), which can harm an unborn baby. Tell your team about strong CYP3A inhibitors such as ketoconazole, which can raise MMAE levels, and strong inducers such as rifampin, which can lower them. Use contraception for 3 months (women) or 5 months (men) after the last dose.
Before Polivy you receive an antihistamine and a fever reducer at least 30 minutes ahead. The first infusion takes 90 minutes, then 30 minutes if tolerated. Staff watch the infusion site for leakage. Tell them straight away about chills, breathing difficulty or rash.
Yes. Polivy (polatuzumab vedotin) commonly causes peripheral neuropathy, in 53% of patients in the POLARIX study, and it builds up over cycles. Tell your care team about numbness, tingling, weakness or trouble walking, because they may adjust your dose. Regular monitoring is part of treatment.
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