What is this drug and how does it work?
For physicians
Which cancers is it used for?
- Chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma, alone or with obinutuzumab or venetoclax [1]
- Mantle cell lymphoma, untreated (with bendamustine and rituximab) or after previous treatment [1]
For physicians
| Disease | Use | Key evidence |
|---|---|---|
| Untreated CLL | Alone or with obinutuzumab [1] | ELEVATE-TN: much longer progression-free survival than chlorambucil-obinutuzumab [2] |
| Relapsed CLL | Monotherapy [1] | ELEVATE-RR: progression-free survival non-inferior to ibrutinib; atrial fibrillation 9.4% vs 16% [3] |
| Mantle cell lymphoma | First line with BR; monotherapy when relapsed [1] | — |
How it is taken and dosing
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Take the tablet every 12 hours with water, with or without food; do not chew or break it. If a dose is more than 3 hours late, skip it and take the next one at the usual time [1].
For physicians
Standard dosing (FDA label)
Acalabrutinib
CLL and mantle cell lymphomaCycle length: Daily and continuous
CLL and mantle cell lymphoma
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Acalabrutinib | 100 mg every 12 hours | Oral | Daily |
With obinutuzumab: obinutuzumab from cycle 2 for 6 cycles. With venetoclax: venetoclax from cycle 3 with a 5-week ramp-up, for 12 cycles. With BR in mantle cell lymphoma: bendamustine 90 mg/m² on days 1 and 2 and rituximab 375 mg/m² on day 1, for 6 cycles. Strong CYP3A inhibitors: avoid (for short courses, hold the drug); moderate inhibitors: 100 mg once daily [1].
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Side effects
The most common side effects: colds and chest infections, diarrhoea, headache, and muscle and bone pain [1]. Headache usually happens in the first weeks and gets better with paracetamol or caffeine.
For physicians
Common adverse reactions (30% or more, excluding laboratory): upper respiratory tract infection, diarrhoea, headache and musculoskeletal pain [1].
Serious side effects
Serious side effects: serious infections, bleeding, low blood counts, a second cancer (especially skin cancer) and heart rhythm changes [1].
For physicians
When should I call my doctor?
- Fever or signs of infection
- Unusual bleeding or bruising, black stools
- Palpitations or dizziness
- A severe headache or sudden confusion
Interactions, pregnancy and precautions
Frequently asked questions
How is acalabrutinib different from ibrutinib?
Both block the same protein; in a head-to-head comparison they worked equally well, but acalabrutinib caused fewer heart rhythm and blood pressure problems [3].
Do I have to take it for the rest of my life?
On its own it is usually continued for as long as it works; with venetoclax, treatment lasts about 14 months and then stops [1].
References
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Numbers in the text, such as [1], refer to these sources. Sources with a “Study card” button are summarised in the site’s evidence library.
- 1
- 2
- 3
This page is based on reputable scientific sources and was last updated on 27 October 2026. The content of this website is for educational and informational purposes only and does not replace consultation, diagnosis or treatment by a specialist physician. Consult your treating physician about any treatment decision.
Printed from the website; the full and up-to-date version: https://drdabiri.com/en/drugs/acalabrutinib/