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BCL-2 Inhibitor Pregnancy: D

Venetoclax

Brand names: Venclyxto

Adult dose

Dose: Ramp-up over 5 weeks: 20 → 50 → 100 → 200 → 400 mg once daily
Route: oral
Frequency: once daily
Max: 400 mg/day
MANDATORY ramp-up to reduce tumour lysis syndrome (TLS) risk; take with food; avoid grapefruit; withhold 2–3 days before/after venetoclax cycle starts

Paediatric dose

Route:
Not licensed in children

Dose adjustments

Renal

No dose adjustment required (avoid if eGFR <30 ml/min — increased TLS risk)

Hepatic

Reduce dose in severe hepatic impairment

Clinical pearls

  • TLS ramp-up is mandatory and carefully protocolised — admit for hospital monitoring at initiation for high-risk patients
  • Co-prescribe allopurinol 2–3 days before and during ramp-up; IV hydration for high-risk
  • MURANO trial: venetoclax + rituximab superior to BR for relapsed CLL

Contraindications

  • Concomitant strong CYP3A4 inhibitors during ramp-up (markedly increase TLS risk)
  • Concurrent live vaccine

Side effects

  • Tumour lysis syndrome (CRITICAL — ramp-up mandatory)
  • Neutropenia
  • Diarrhoea
  • Nausea
  • Anaemia
  • Infections (PCP, CMV prophylaxis may be needed)

Interactions

  • Strong CYP3A4/P-gp inhibitors (azoles, clarithromycin — hold or reduce dose)
  • Strong CYP3A4 inducers (rifampicin — avoid)
  • Warfarin (increased INR)

Monitoring

  • TLS monitoring (urate, potassium, phosphate, creatinine)
  • FBC weekly × 3 months
  • Signs of infection
  • LFTs

Reference: BNFc; BNF 86; NICE TA487; MURANO trial. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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