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Antibody-Drug Conjugate (CD79b) Pregnancy: Can cause fetal harm based on animal findings and mechanism of action. There are no available data in pregnant women to inform the drug-associated risk. In pregnant rats, two intravenous doses of MMAE (the small molecule component) on gestational days 6 and 13, at exposures below the clinical exposure at the recommended 1.8 mg/kg every 21 days, caused embryo-fetal mortality and structural abnormalities. Advise a pregnant woman of the potential risk to a fetus; females of reproductive potential should use effective contraception during treatment and for 3 months after the last dose.

Polatuzumab Vedotin

Brand names: Polivy

Polatuzumab vedotin is an antibody-drug conjugate targeting CD79b, used with rituximab and bendamustine, or in other combinations, for diffuse large B-cell lymphoma.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 1.8 mg/kg
Route: Intravenous infusion — administer the initial dose over 90 minutes; subsequent infusions may be administered over 30 minutes if the previous infusion was tolerated
Frequency: Every 21 days for 6 cycles
Previously untreated DLBCL, NOS or high-grade B-cell lymphoma (HGBL): 1.8 mg/kg intravenously every 21 days for 6 cycles in combination with a rituximab product, cyclophosphamide, doxorubicin and prednisone; give polatuzumab vedotin, cyclophosphamide, doxorubicin and the rituximab product in any order on Day 1 after prednisone, with prednisone given on Days 1-5 of each cycle. Relapsed or refractory DLBCL, NOS: 1.8 mg/kg intravenously every 21 days for 6 cycles in combination with bendamustine and a rituximab product, all given in any order on Day 1 of each cycle; the label states the recommended bendamustine dose is 90 mg/m2/day on Days 1 and 2 when given with this combination, and the rituximab product dose is 375 mg/m2 intravenously on Day 1 of each cycle. Premedication: if not already premedicated, administer an antihistamine and an antipyretic at least 30 minutes before each dose. Missed dose: administer as soon as possible and adjust the schedule to maintain a 21-day interval between doses. Dose reduction levels for adverse reactions (peripheral neuropathy, infusion-related reactions, myelosuppression): starting dose 1.8 mg/kg, first reduction level 1.4 mg/kg, second reduction level 1 mg/kg; no further reduction beyond 1 mg/kg is recommended — discontinue if further reduction is needed. R-CHP should be continued if polatuzumab vedotin is withheld. Grade 4 peripheral sensory or motor neuropathy, first instance of Grade 3 wheezing/bronchospasm/generalised urticaria, recurrent Grade 2 wheezing or urticaria, recurrence of any Grade 3 infusion-related symptoms, or a Grade 4 infusion-related reaction all require permanent discontinuation. Grade 3-4 neutropenia: hold all treatment until ANC recovers to at least 1,000/microlitre. Grade 3-4 thrombocytopenia: hold all treatment until platelets recover to at least 75,000/microlitre. Ensure patent venous access before starting and monitor the infusion site for extravasation. No renal dose adjustment is stated in the fetched label. Paediatric use: the US label states safety and effectiveness in paediatric patients have not been established — no paediatric dose is given; verify any paediatric use against a children's formulary and specialist protocol. No UK SPC (eMC) record was present in the source bundle — this dose is from US prescribing information and must be verified against UK labelling.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • None (US label §4 states: None)

Side effects

  • Peripheral neuropathy (sensory and motor)
  • Nausea, diarrhoea, constipation and mucositis
  • Fatigue and alopecia
  • Myelosuppression — neutropenia, thrombocytopenia, anaemia, lymphopenia
  • Infusion-related reactions and infusion site extravasation injury
  • Serious and opportunistic infections, pyrexia, decreased appetite and pneumonia (in the relapsed/refractory setting); hepatotoxicity, tumour lysis syndrome and progressive multifocal leukoencephalopathy are also labelled risks

Interactions

  • Strong CYP3A4 inhibitors: concomitant use may increase unconjugated monomethyl auristatin E (MMAE) AUC, which may increase toxicity — monitor patients for signs of toxicity
  • Strong CYP3A4 inducers: concomitant use may decrease unconjugated MMAE AUC

Clinical monograph

How it works

The anti-CD79b antibody delivers the microtubule-disrupting agent monomethyl auristatin E (MMAE) into B cells, where it inhibits cell division and induces apoptosis of CD79b-expressing malignant cells.

Prescribing in practice

  • Peripheral neuropathy is a characteristic dose-limiting toxicity; assess at each cycle and interrupt, reduce or stop treatment if it worsens.
  • Serious infections, myelosuppression, infusion-related reactions and tumour lysis syndrome can occur, warranting appropriate prophylaxis and monitoring.
  • It is given by intravenous infusion as part of a combination regimen under specialist supervision in line with the SPC.

Monitoring

Monitor full blood count, for signs of infection and infusion reactions, and assess for peripheral neuropathy before each cycle.

Counselling the patient

  • Advise reporting numbness, tingling, weakness or burning in the hands or feet promptly.
  • Highlight the importance of reporting signs of infection given the risk of low blood counts.

Evidence & guidelines

The POLARIX and earlier GO29365 studies support polatuzumab vedotin combinations in diffuse large B-cell lymphoma.

Reference: POLARIX trial (Tilly et al. NEJM 2022); NICE TA662; NICE TA862; MHRA SPC Polivy; GO29365 trial (Sehn et al. JCO 2020); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.