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acalabrutinib

Calquence · ATC code L01EL02

Key facts
Active substance
acalabrutinib
ATC code
L01EL02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Calquence 100 mg hard capsules · Calquence 100 mg film-coated tablets
Marketing authorisation holder
AstraZeneca AB
Information as of
2026-10-27

Key facts

Acalabrutinib is a Bruton tyrosine kinase (BTK) inhibitor. It is used in adults to treat chronic lymphocytic leukaemia (CLL) and mantle cell lymphoma (MCL).

What it is used for

  • Previously untreated CLL in adults: monotherapy or combined with obinutuzumab
  • Previously untreated CLL: combined with venetoclax with or without obinutuzumab
  • CLL after at least one prior therapy: monotherapy
  • Previously untreated MCL not eligible for autologous stem cell transplant: combined with bendamustine and rituximab
  • Relapsed or refractory MCL not previously treated with a BTK inhibitor: monotherapy

Dosing

  • Calquence (hard capsules and film-coated tablets): 100 mg twice daily, about 12 hours apart, as monotherapy or in combination
  • Monotherapy or with obinutuzumab: continue until disease progression or unacceptable toxicity
  • With venetoclax (± obinutuzumab): a total of 14 cycles; partner-drug schedules are in the full text
  • Dose modifications for Grade ≥ 3 adverse reactions and CYP3A interactions are described in the full text
  • Mild or moderate hepatic or renal impairment: no dose adjustment; severe hepatic impairment: not recommended
  • Missed dose by more than 3 hours: take the next dose at the regular time; do not double

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Major haemorrhage including CNS and gastrointestinal bleeding, some fatal; caution with antithrombotic agents; do not co-administer warfarin or other vitamin K antagonists
  • Serious infections (bacterial, viral, fungal), including fatal events; HBV and herpes zoster reactivation, aspergillosis and PML have occurred
  • Grade 3 or 4 cytopenias (neutropenia, anaemia, thrombocytopenia); monitor blood counts
  • Second primary malignancies, commonly skin cancers; sun protection and skin monitoring
  • Atrial fibrillation/flutter; monitor symptoms and obtain an ECG as indicated
  • Consider withholding for at least 3 days pre- and post-surgery

Side effects

  • Monotherapy, most common (≥ 20%): infection, diarrhoea, headache, musculoskeletal pain, bruising, cough, arthralgia, fatigue, nausea, rash
  • Most common Grade ≥ 3 (≥ 5%): infection, leukopenia, neutropenia, anaemia, second primary malignancy, thrombocytopenia
  • In combinations also dizziness and constipation, among others

Interactions

  • Avoid strong CYP3A/P-gp inhibitors (e.g. itraconazole, clarithromycin, ritonavir); interrupt treatment if used short-term
  • Hard capsules: avoid proton pump inhibitors; antacids and H2-receptor antagonists only with dose separation
  • Film-coated tablets can be co-administered with gastric acid reducing agents
  • Antithrombotic agents increase bleeding risk; no vitamin K antagonists

Pregnancy and breastfeeding

  • Pregnancy: not to be used unless the woman's clinical condition requires treatment; women of childbearing potential should avoid pregnancy
  • Breast-feeding is not advised during treatment and for 2 days after the last dose

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Turkey

  • CalquenceASTRAZENECA İLAÇ SAN. VE TİC. LTD. ŞTİ. · 4 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Calquence
Liechtenstein
Calquence
Norway
Calquence

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

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Sources

  1. European Medicines Agency. Calquence – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/calquence-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.