Prescription medicine
Rilzabrutinib Brand names: Wayrilz
Rilzabrutinib (Wayrilz) is a prescription medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the rilzabrutinib FDA label on DailyMed (effective August 26, 2025, Genzyme Corporation); the NDA 219685 record on Drugs@FDA; every rilzabrutinib label on DailyMed.
Highlights of the record
FDA label of August 26, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageWAYRILZ 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.
Forms and strengths
- 400 mg
Film-coated tablet.
On the market
- Earliest approval on file
- August 29, 2025 Wayrilz, Genzyme Corp; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 20, 2041 Wayrilz tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 363 through July 30, 2026
What is rilzabrutinib used for?
From the label: indications and usageWAYRILZ 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.
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (WAYRILZ), Genzyme Corporation, effective August 26, 2025 (SPL set 95ffd367-9b0c-4f75-8487-5d8f3c0a5ad0), via openFDA; the full label on DailyMed
What does the patient leaflet for rilzabrutinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking WAYRILZ?You should avoid grapefruit, starfruit and products that have these fruits, and Seville oranges (often used in marmalades) during treatment with WAYRILZ. These products may increase the amount of WAYRILZ in your blood, which increases the risk of side effects of WAYRILZ.
From the patient leaflet: How should I store WAYRILZ?Store WAYRILZ at room temperature between 20°C to 25°C (68°F to 77°F). Store WAYRILZ tablets in the original packaging. Protect WAYRILZ from light and moisture. Keep WAYRILZ and all medicines out of the reach of children.
Source: FDA drug label (WAYRILZ), Genzyme Corporation, effective August 26, 2025 (SPL set 95ffd367-9b0c-4f75-8487-5d8f3c0a5ad0), via openFDA; the full label on DailyMed
Is there a generic for rilzabrutinib (Wayrilz)?
No generic rilzabrutinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Wayrilz tablets: the compound patent runs to February 20, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2025 earliest approval on file
- 2041 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for rilzabrutinib?
The FDA Adverse Event Reporting System holds 363 reports that list rilzabrutinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 55 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Rilzabrutinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other