Molecule
Rilzabrutinib is a kinase inhibitor indicated for the treatment of adult patients with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. It is available as tablets for oral use. MedsAcross supplies Rilzabrutinib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
WAYRILZ is indicated for the treatment of adult patients with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. WAYRILZ is a kinase inhibitor indicated for the treatment of adult patients with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
Source: US FDA prescribing information
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. In vitro, rilzabrutinib reduced autoantibody signaling mediated through the FcγR pathway, blocked B cell signaling, and decreased autoantibody generation through effects on B cell activation.
Source: US FDA prescribing information
See Full Prescribing Information for important recommendations prior to treatment. Recommended dosage: 400 mg orally twice daily, swallow whole with water, with or without food. Do not cut, crush, or chew tablets.
Source: US FDA prescribing information
None None
Source: US FDA prescribing information
Serious Infections: Monitor patients for signs and symptoms of infection, evaluate promptly, and treat. Hepatotoxicity, Including Drug-Induced Liver Injury: Evaluate bilirubin and transaminases at baseline and as clinically indicated during treatment. Embryo-Fetal Toxicity: Based on preliminary animal data, WAYRILZ may cause fetal harm. Advise females of reproductive potential of the potential risk and to use effective contraception.
Source: US FDA prescribing information
The following clinically important adverse reactions are described elsewhere in the labeling: Serious Infections Hepatotoxicity, Including Drug-Induced Liver Injury Most common adverse reactions (incidence ≥10%) were diarrhea, nausea, headache, abdominal pain, and COVID-19.
Source: US FDA prescribing information
CYP3A Inhibitors: Avoid co-administration with moderate or strong CYP3A inhibitors. CYP3A Inducers: Avoid co-administration with moderate or strong CYP3A inducers. Gastric Acid Reducing Agents: Avoid co-administration with proton pump inhibitors (PPIs). WAYRILZ should be administered at least 2 hours before taking an antacid or H2 receptor antagonist.
Source: US FDA prescribing information
Store at room temperature between 20°C to 25°C (68°F to 77°F), excursions are permitted between 15°C to 30°C (59°F to 86°F). Store and dispense in the original package. Protect from light and moisture.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Rilzabrutinib, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Wayrilz 400 mg tabletOral | Genzyme | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Rilzabrutinib and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Rilzabrutinib, including Wayrilz.
Yes. The US FDA first approved Rilzabrutinib on 29 August 2025, according to Drugs@FDA.
Yes. Rilzabrutinib has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Rilzabrutinib is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.