Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Sanofi B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
WAYRILZ is indicated for the treatment of immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (see section 5.1).
Treatment should be initiated and remain under the supervision of a physician who is experienced in the treatment of haematological diseases.
The recommended dose of rilzabrutinib is 400 mg twice daily.
Recommended use with cytochrome P450 enzyme 3A (CYP3A) inhibitors or inducers and gastric acid reducing agents are provided in Table 1 (see section 4.5).
Table 1. Use with CYP3A inhibitors or inducers and gastric acid reducing agents:
| Co-administered medicinal product | Recommended use | |
| CYP3A inhibitors | Strong and moderate CYP3A inhibitor | Avoid co-administration of rilzabrutinib with moderate or strong CYP3A inhibitors. If these inhibitors will be used short-term (such as anti- infectives for up to seven days), interrupt rilzabrutinib. |
| Avoid co-administration of grapefruit, starfruit and products containing these fruits, and Seville oranges with rilzabrutinib, as these are moderate or strong inhibitors of CYP3A. | ||
| Weak CYP3A inhibitor | No dose adjustment. | |
| CYP3A inducers | Strong and moderate CYP3A inducers | Avoid co-administration of rilzabrutinib with moderate or strong CYP3A inducers. |
| Weak CYP3A inducer | No dose adjustment. | |
| Gastric acid reducing agents | Proton pump inhibitors (PPIs) | Avoid co-administration of rilzabrutinib with PPIs. |
| H2-receptor antagonists or antacid | If treatment with a gastric acid reducing agent is required, consider using a H2-receptor antagonist (H2RA) or antacid. Take rilzabrutinib at least 2 hours before taking the H2RA or antacid. |
If a dose of rilzabrutinib is missed, patients should take the missed dose as soon as possible on the same day with a return to the regular schedule the following day. The missed dose and the next regular scheduled dose must be taken more than 2 hours apart. Extra tablets should not be taken to make up for the missed dose.
Treatment with rilzabrutinib should be discontinued after 12 weeks of rilzabrutinib therapy if the platelet count does not increase to a level sufficient to avoid clinically important bleeding.
No dose modification is required for elderly (≥65 years) patients (see section 5.2).
No dose modification is required in patients with mild or moderate renal impairment. Rilzabrutinib has not been studied in clinical trials in patients with severe renal impairment (see section 5.2).
No dose modification is required in patients with mild (Child-Pugh Class A) hepatic impairment. Rilzabrutinib has not been studied in clinical trials in patients with severe (Child-Pugh Class C) hepatic impairment. In patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment, rilzabrutinib should not be administered (see section 5.2).
The safety and efficacy of rilzabrutinib in children and adolescents below 18 years of age with ITP have not been established. No data are available.
Rilzabrutinib is for oral use.
The tablets can be taken at approximately the same time each day with or without food (see section 5.2). In patients who experience gastrointestinal symptoms, taking rilzabrutinib with food may improve tolerability. Patients should be instructed to swallow the tablets whole with water. The tablets should not be split, crushed, or chewed in order to ensure the entire dose is delivered correctly.
There is no specific antidote for overdose with rilzabrutinib. In the event of overdose, closely monitor the patient for any signs or symptoms of adverse reactions and appropriate symptomatic treatment immediately.
3 years.
This medicinal product does not require any special temperature storage conditions.
Store in the original package in order to protect from moisture.
White, opaque polyvinyl chloride (PVC)/polychlorotrifluoroethylene (PCTFE)-aluminium blister pack in a cardboard wallet with sun/moon symbols containing 28 film-coated tablets.
Pack sizes:
Each blister wallet contains 28 film-coated tablets.
Each pack contains:
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements. No special requirements for disposal.
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