Wayrilz
- Prescription status not stated
- Active substance
- Rilzabrutinib
- Made by
- Sanofi B.V.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- Wayrilz is indicated for the treatment of immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (see section 5.1)
From the official label · 2026-09-30 · European Medicines Agency
How it works
From the US prescribing label for the same active substance (WAYRILZ). It describes the substance, not this exact product.
Rilzabrutinib is a small-molecule, covalent, reversible kinase inhibitor targeting Bruton's tyrosine kinase (BTK).
Rilzabrutinib mediates its therapeutic effect in ITP through immune modulation including 1) inhibition of B cell activation, and 2) interruption of antibody-coated cell phagocytosis by Fcγ receptor (FcγR) in spleen and liver.
Rilzabrutinib is predominantly metabolized by cytochrome P450 3A.
Approximately 0.03% of rilzabrutinib was excreted unchanged in the urine.
Effect of Food: Rilzabrutinib AUC and C max decreased by 20% and 31%, respectively, following administration of a single oral 400 mg dose with a high fat meal (approximately 1,000 calories with 50% of total caloric content from fat).
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-08-26
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
Details
| Made by | Sanofi B.V. |
|---|---|
| Active substance | Rilzabrutinib |
| Orphan medicine | Yes — designated for a rare disease, according to the register |
| Additional monitoring ▼ | Yes — under additional monitoring (black triangle). Report suspected side effects. |
| Authorised on | 2025-12-22 |
| Last updated by the regulator | 2026-01-08 |
| EMA product number | EMEA/H/C/006425 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).