BTK Inhibitor — CLL / MCL Pregnancy: Based on findings in animals, acalabrutinib may cause fetal harm and dystocia when given to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. Advise pregnant women of the potential risk to a fetus.

Acalabrutinib

Brand names: Calquence

Acalabrutinib is an oral Bruton tyrosine kinase (BTK) inhibitor used to treat chronic lymphocytic leukaemia and mantle 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: 100 mg

Route: Oral — swallow the tablet whole with water; do not chew, crush, dissolve or cut. May be taken with or without food.

Frequency: Approximately every 12 hours, continued until disease progression or unacceptable toxicity

INDICATIONS AND COMBINATIONS (all use the same 100 mg approximately every 12 hours dose): monotherapy for mantle cell lymphoma (MCL), chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL); in combination with bendamustine and rituximab for previously untreated MCL (start on Day 1 of Cycle 1, 28-day cycles; bendamustine 90 mg/m2 on Days 1 and 2 and rituximab 375 mg/m2 on Day 1 of Cycle 1 for a total of 6 cycles, with optional maintenance rituximab); in combination with obinutuzumab for previously untreated CLL/SLL (acalabrutinib from Cycle 1, obinutuzumab from Cycle 2 for 6 cycles; give acalabrutinib before obinutuzumab on the same day); in combination with venetoclax for previously untreated CLL/SLL, until progression, unacceptable toxicity or completion of 14 cycles (venetoclax from Cycle 3 for 12 cycles, with its own 5-week ramp up). MISSED DOSE: if missed by more than 3 hours, skip it and take the next dose at its regularly scheduled time; do not take extra tablets. CYP3A DOSE MODIFICATIONS: avoid strong CYP3A inhibitors — if short-term use is needed (such as anti-infectives for up to seven days) interrupt acalabrutinib and resume the previous dose at least 24 hours after the inhibitor is stopped; with a moderate CYP3A inhibitor reduce 100 mg every 12 hours to 100 mg once daily; avoid strong CYP3A inducers — if co-administration is unavoidable increase to 200 mg approximately every 12 hours. TOXICITY MODIFICATIONS (monotherapy and with obinutuzumab): for Grade 3 or greater non-haematological toxicity, Grade 3 thrombocytopenia with bleeding, Grade 4 thrombocytopenia, or Grade 4 neutropenia lasting longer than 7 days — interrupt; on the first and second occurrence resume at 100 mg approximately every 12 hours once toxicity resolves to Grade 1 or baseline; on the third occurrence resume at a reduced frequency of 100 mg once daily; discontinue on the fourth occurrence. HEPATIC: avoid acalabrutinib in patients with severe hepatic impairment. PAEDIATRIC: safety and efficacy in paediatric patients have not been established. SOURCE: no UK SPC was fetched in this bundle — this draft is distilled from the US CALQUENCE prescribing information and must be verified against the UK SPC.

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 stated — the US label section 4 Contraindications reads 'None'

Side effects

Upper respiratory tract infection (most common, at least 30%)
Diarrhoea (most common, at least 30%)
Headache (most common, at least 30%)
Musculoskeletal pain (most common, at least 30%)
Serious and opportunistic infections — serious or Grade 3 or higher infections occurred in 29% of 2,055 patients, most often respiratory tract infections including pneumonia in 14%
Grade 3 or 4 laboratory abnormalities (at least 10%): absolute neutrophil count decreased, uric acid increased, absolute lymphocyte count decreased, platelets decreased. Haemorrhage, cytopenias, second primary malignancies, cardiac arrhythmias and hepatotoxicity including drug-induced liver injury are also labelled warnings.

Interactions

Strong CYP3A inhibitors — increase acalabrutinib plasma concentrations and may increase toxicity; avoid co-administration, or interrupt acalabrutinib if the inhibitor is short-term
Moderate CYP3A inhibitors — may increase acalabrutinib plasma concentrations; reduce the acalabrutinib dosage to 100 mg once daily
Strong CYP3A inducers — decrease acalabrutinib plasma concentrations; avoid co-administration, and if unavoidable increase the dosage to 200 mg approximately every 12 hours

Clinical monograph

How it works

It selectively and covalently inhibits BTK, blocking B-cell receptor signalling required for the proliferation and survival of malignant B cells.

Prescribing in practice

It increases the risk of bleeding, so use with caution alongside antiplatelet or anticoagulant therapy and consider withholding around surgery.
Acid-reducing agents can lower absorption, so co-administration with proton pump inhibitors should be avoided and antacids separated in time.
Atrial fibrillation, cytopenias and serious infections can occur and warrant monitoring.

Monitoring

Monitor full blood count periodically and remain alert for bleeding, new arrhythmia and signs of infection.

Counselling the patient

Report unusual bruising, bleeding or an irregular or fast heartbeat.
Avoid taking acid-suppressing stomach medicines unless agreed with your specialist team.
Tell any surgeon or dentist that you take this medicine before procedures.

Evidence & guidelines

NICE recommends acalabrutinib as an option for untreated and previously treated chronic lymphocytic leukaemia.

Reference: ELEVATE-TN Trial (Sharman et al. Lancet 2020); ASCEND Trial (Ghia et al. JCO 2020); NICE TA683; SPC Calquence; 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).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways