rilzabrutinib
Wayrilz · ATC code Not yet assigned
- Key facts
- Active substance
- rilzabrutinib
- ATC code
- Not yet assigned
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- WAYRILZ 400 mg film-coated tablets
- Marketing authorisation holder
- Sanofi B.V.
- Information as of
- 2026-10-29
Key facts
Rilzabrutinib is a Bruton's tyrosine kinase (BTK) inhibitor. It is used in adults with immune thrombocytopenia (ITP) who are refractory to other treatments.
What it is used for
- Treatment of immune thrombocytopenia (ITP) in adults who are refractory to other treatments (Wayrilz).
Dosing
- Wayrilz 400 mg film-coated tablets: 400 mg twice daily.
- Avoid moderate or strong CYP3A inhibitors and inducers and proton pump inhibitors; interrupt rilzabrutinib if such an inhibitor is used short-term (e.g. an anti-infective for up to seven days). Avoid grapefruit, starfruit and Seville oranges.
- If an acid-reducing agent is needed: an H2-receptor antagonist or antacid; take rilzabrutinib at least 2 hours before it.
- Missed dose: take it the same day (more than 2 hours apart from the next dose); no extra tablets.
- Discontinue after 12 weeks if platelets do not rise sufficiently. No adjustment in the elderly, mild or moderate renal impairment or mild hepatic impairment; do not use in moderate or severe hepatic impairment.
Contraindications
- Hypersensitivity to the active substance or any of the excipients.
Important warnings
- Serious bacterial, viral or fungal infections: monitor for signs of infection.
- Women of childbearing potential must use highly effective contraception; verify pregnancy status before starting.
- Check bilirubin and transaminases at baseline and as clinically indicated.
- QTc shortening in a thorough QT study; caution in patients at risk of further QTc shortening (e.g. congenital short QT syndrome).
Side effects
- Most common: diarrhoea (34.5%), nausea (25.4%), headache (18.3%), abdominal pain (15.8%), COVID-19 (15.5%), nasopharyngitis (11.6%) and arthralgia (11.3%).
- Common: pneumonia, dizziness, cough.
Interactions
- The strong CYP3A inhibitor ritonavir increased AUC by about 8-fold; avoid moderate or strong CYP3A inhibitors (e.g. clarithromycin, itraconazole, fluconazole, verapamil, diltiazem) and inducers.
- Caution with sensitive narrow-therapeutic-range substrates of P-gp, BCRP or OATP1B3 (e.g. digoxin, ciclosporin, tacrolimus).
- Effect on hormonal contraceptives is unknown.
Pregnancy and breastfeeding
- Do not use in pregnancy or in women not using contraception; highly effective contraception during and for 1 month after treatment.
- Breast-feeding: see the full text.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
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)
- WayrilzSanofi B.V. · EMEA/H/C/006425
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Wayrilz
- Liechtenstein
- Wayrilz
- Norway
- Wayrilz
EMA – Article 57 product data (EU/EEA), 2026-10-29
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Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Wayrilz – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/wayrilz-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-29 · 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.