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remibrutinib

Rhapsido · ATC code L04AA60

Key facts
Active substance
remibrutinib
Drug class
Immunosuppressive drug
ATC code
L04AA60
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Rhapsido 25 mg film-coated tablets
Marketing authorisation holder
Novartis Europharm Limited
Information as of
2026-10-27

Key facts

Remibrutinib is an oral Bruton's tyrosine kinase inhibitor (Rhapsido film-coated tablets). It is used in adults with chronic spontaneous urticaria not adequately controlled by H1 antihistamines.

What it is used for

  • Chronic spontaneous urticaria (CSU) in adults with inadequate response to H1 antihistamine treatment

Dosing

  • 25 mg twice daily (morning and evening), with or without food, swallowed whole with water
  • Do not take extra doses for missed doses; take the next dose at the usual time
  • Reassess periodically; consider stopping if no response after 24 weeks
  • Interrupt for 3 to 7 days before and after surgery, depending on bleeding risk
  • No adjustment in renal impairment or mild to moderate hepatic impairment; not recommended in severe hepatic impairment

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Bleeding risk: mild to moderate mucocutaneous bleeding (mainly petechiae, contusion); increased with antithrombotic agents
  • Interrupt treatment if significant bleeding is suspected
  • Live or live-attenuated vaccines are not recommended during treatment
  • Not for children below 6 years (possible impact on humoral immunity maturation)

Side effects

  • Most frequent: upper respiratory tract infections (14.7%), such as nasopharyngitis (6.6%) and influenza (2.5%)
  • Common: herpes virus infections, headache, bruising, petechiae, haematuria, nausea, abdominal pain, back pain, pyrexia
  • Uncommon: purpura, epistaxis, conjunctival and gingival bleeding

Interactions

  • Avoid strong CYP3A4 inhibitors; ritonavir led to a 4.3-fold increase in remibrutinib AUC
  • Avoid strong or moderate CYP3A4 inducers; carbamazepine markedly decreased exposure
  • P-gp and BCRP substrates with a narrow therapeutic index (e.g. digoxin): monitor more frequently
  • Antithrombotic agents: increased bleeding risk

Pregnancy and breastfeeding

  • Pregnancy: not recommended; women of childbearing potential must use effective contraception during and for at least 1 week after treatment
  • Breast-feeding: discontinue during treatment and for 1 week 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)

  • RhapsidoNovartis Europharm Limited · EMEA/H/C/006313

Source: European Medicines Agency (EMA), product information

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

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?

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Sources

  1. European Medicines Agency. Rhapsido – 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/rhapsido-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC L04AA.

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.