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ibrutinib

Imbruvica · ATC code L01EL01

Key facts
Active substance
ibrutinib
ATC code
L01EL01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
IMBRUVICA 140 mg hard capsules · IMBRUVICA 140 mg film-coated tablets / IMBRUVICA 280 mg film-coated tablets / IMBRUVICA 420 mg film-coated tablets
Marketing authorisation holder
Janssen-Cilag International NV
Information as of
2026-10-27

Key facts

Ibrutinib (IMBRUVICA) is an oral Bruton's tyrosine kinase inhibitor. It is used in adults with B-cell malignancies: mantle cell lymphoma, chronic lymphocytic leukaemia and Waldenström's macroglobulinaemia.

What it is used for

  • Mantle cell lymphoma (MCL): previously untreated (with chemoimmunotherapy) and relapsed or refractory (single agent)
  • Chronic lymphocytic leukaemia (CLL), as single agent or in combination
  • Waldenström's macroglobulinaemia (WM), as single agent or in combination
  • Exact indication wording: see the full product information

Dosing

  • MCL: 560 mg once daily; in untreated MCL alternating with R-CHOP/R-DHAP, then daily for 24 months
  • CLL and WM: 420 mg once daily, until disease progression or intolerance
  • CLL with venetoclax: 3 cycles of ibrutinib alone, then 12 cycles with venetoclax
  • With moderate CYP3A4 inhibitors reduce to 280 mg; with strong inhibitors reduce to 140 mg or withhold for up to 7 days
  • Withhold for serious cardiac or other toxicities and resume per the full product information

Contraindications

  • Hypersensitivity to the active substance or any of the excipients
  • Preparations containing St. John's Wort

Important warnings

  • Bleeding, some fatal; no vitamin K antagonists, caution with anticoagulants and antiplatelets; hold 3 to 7 days around surgery
  • Fatal and serious cardiac arrhythmias and cardiac failure; atrial fibrillation
  • Hepatotoxicity, hepatitis B reactivation, hepatic failure; assess liver function and viral hepatitis status before starting
  • Leukostasis, tumour lysis syndrome, infections
  • Non-melanoma skin cancer reported more frequently

Side effects

  • Most common (≥20%): diarrhoea, neutropenia, musculoskeletal pain, haemorrhage (e.g. bruising), rash, nausea, thrombocytopenia, arthralgia, upper respiratory tract infection
  • Most common grade 3/4: neutropenia, lymphocytosis, thrombocytopenia, hypertension, pneumonia

Interactions

  • Strong and moderate CYP3A4 inhibitors increase ibrutinib exposure; avoid strong inhibitors
  • No concomitant warfarin or other vitamin K antagonists; avoid fish oil and vitamin E supplements

Pregnancy and breastfeeding

  • Should not be used in pregnancy; women must use highly effective contraception during treatment and for three months after

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)

  • ImbruvicaJanssen-Cilag International NV · EMEA/H/C/003791

Source: European Medicines Agency (EMA), product information

Turkey

  • ImbruvicaJOHNSON AND JOHNSON SIHHİ MAL. SAN. VE TİC. LTD. ŞTİ. · 6 register entries

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

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

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

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Imbruvica – EPAR, Product Information. 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/imbruvica-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.