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BTK Inhibitor — CLL / MCL Pregnancy: Contraindicated — teratogenic; effective contraception required during and for 1 week after treatment

Acalabrutinib

Brand names: Calquence

Adult dose

Dose: 100 mg twice daily
Route: Oral
Frequency: Twice daily (approximately 12 hours apart)
Max: 100 mg twice daily
Second-generation BTK inhibitor. Used for chronic lymphocytic leukaemia (CLL — first-line and relapsed/refractory) and mantle cell lymphoma (MCL — relapsed/refractory). More selective than ibrutinib — fewer off-target effects (less atrial fibrillation, less bleeding, better tolerated).

Paediatric dose

Dose: Seek specialist opinion mg/kg
Route: Oral
Frequency: Twice daily
Max: Not established in children
Not licensed in children — specialist paediatric haematology opinion required

Dose adjustments

Renal

No dose adjustment required

Hepatic

No dose adjustment in mild-moderate hepatic impairment; avoid in severe impairment

Paediatric weight-based calculator

Not licensed in children — specialist paediatric haematology opinion required

Clinical pearls

  • ELEVATE-TN trial: acalabrutinib ± obinutuzumab superior to chlorambucil + obinutuzumab in treatment-naive CLL (PFS benefit)
  • ASCEND trial: acalabrutinib superior to idelalisib + rituximab or bendamustine + rituximab in relapsed/refractory CLL
  • Headache is very common at initiation (caffeine may worsen) — usually resolves within 1–2 months; paracetamol for symptom relief
  • Lower rate of atrial fibrillation vs ibrutinib (~3–4% vs ~10–16% with ibrutinib) — important for patients with cardiac history
  • PPIs significantly reduce absorption — avoid concomitant use; switch to antacid (separate by 2h) or H2 blocker if needed
  • PCP and fungal infection prophylaxis (e.g. cotrimoxazole + antifungal) during periods of lymphocyte nadir

Contraindications

  • Hypersensitivity to acalabrutinib
  • Pregnancy

Side effects

  • Headache (very common — especially first month)
  • Diarrhoea
  • Bruising
  • Anaemia
  • Neutropenia
  • Atrial fibrillation (lower rate than ibrutinib)
  • Infections (including PCP, fungal)
  • Hypertension

Interactions

  • Strong CYP3A4 inhibitors (azoles, macrolides) — increase acalabrutinib exposure; avoid or reduce dose
  • Strong CYP3A4 inducers (rifampicin, carbamazepine) — reduce efficacy
  • Anticoagulants — increased bleeding risk (avoid concomitant anticoagulation where possible)
  • PPIs — significantly reduce absorption; avoid (use antacid or H2 blocker instead, 2h apart)

Monitoring

  • FBC (before each cycle)
  • Atrial fibrillation monitoring (symptoms, pulse, ECG)
  • Blood pressure
  • Infection surveillance
  • LFTs

Reference: BNFc; BNF 90; ELEVATE-TN Trial (Sharman et al. Lancet 2020); ASCEND Trial (Ghia et al. JCO 2020); NICE TA683; SPC Calquence. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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