Polatuzumab Vedotin
Polivy · ATC code L01FX14
- Key facts
- Active substance
- Polatuzumab Vedotin
- ATC code
- L01FX14
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Polivy 30 mg powder for concentrate for solution for infusion. / Polivy 140 mg powder for concentrate for solution for infusion.
- Marketing authorisation holder
- Roche Registration GmbH
- Information as of
- 2026-10-28
Key facts
Polatuzumab vedotin is a CD79b-targeted antibody-drug conjugate used to treat diffuse large B-cell lymphoma (DLBCL) in adults (Polivy, intravenous infusion).
What it is used for
- With rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP) in adults with previously untreated DLBCL.
- With bendamustine and rituximab in adults with relapsed/refractory DLBCL who are not candidates for haematopoietic stem cell transplant.
Dosing
- Previously untreated DLBCL: 1.8 mg/kg as an intravenous infusion every 21 days with R-CHP for 6 cycles.
- Relapsed/refractory DLBCL: 1.8 mg/kg every 21 days with bendamustine (90 mg/m²/day on Day 1 and Day 2) and rituximab (375 mg/m² on Day 1) for 6 cycles; do not exceed 240 mg per cycle.
- Premedicate with an antihistamine and anti-pyretic before administration.
- For peripheral neuropathy, dose reduction (e.g. to 1.4 mg/kg, then 1.0 mg/kg), withholding or discontinuation; details: see the full text.
- A missed dose should be given as soon as possible, keeping a 21-day interval.
- No adjustment for creatinine clearance ≥ 30 mL/min; avoid in moderate or severe hepatic impairment.
Contraindications
- Hypersensitivity to the active substance or any excipient.
- Active severe infections.
Important warnings
- Myelosuppression (severe neutropenia, febrile neutropenia, thrombocytopenia, anaemia): blood counts before each dose; consider G-CSF prophylaxis.
- Peripheral neuropathy, predominantly sensory; risk increases with sequential doses.
- Serious, including fatal, infections including opportunistic ones; consider anti-infective prophylaxis; no live vaccines.
- Progressive multifocal leukoencephalopathy (PML), tumour lysis syndrome and infusion-related reactions (delayed up to 24 hours).
- Can be harmful to the foetus.
Side effects
- Previously untreated DLBCL with R-CHP, most frequent (≥ 30%): peripheral neuropathy (52.9%), nausea (41.6%), neutropenia (38.4%) and diarrhoea (30.8%).
- Serious adverse reactions in 24.1%, most commonly febrile neutropenia (10.6%) and pneumonia (5.3%).
- Data in relapsed/refractory DLBCL: see the full text.
Interactions
- Strong CYP3A4 and P-gp inhibitors (e.g. ketoconazole, clarithromycin, itraconazole, ritonavir, voriconazole) may increase MMAE exposure; monitor more closely for toxicity.
Pregnancy and breastfeeding
- Women of childbearing potential should use effective contraception during treatment and for at least 9 months afterwards; men with partners of childbearing potential for at least 6 months.
- Discontinue breast-feeding during treatment and for at least 3 months after the last dose.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- PolivyRoche Registration GmbH · EMEA/H/C/004870
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Polivy
- Liechtenstein
- Polivy
- Norway
- Polivy
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Polivy – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/polivy-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.