Brand Name
Wayrilz
Generic Name
Rilzabrutinib
View Brand Information FDA approval date: August 26, 2025
Form: Tablet
What is Wayrilz (Rilzabrutinib)?
WAYRILZ is indicated for the treatment of adult patients with persistent or chronic immune thrombocytopenia 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 who have had an insufficient response to a previous treatment.
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Brand Information
WAYRILZ (rilzabrutinib)
1INDICATIONS AND USAGE
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.
2DOSAGE FORMS AND STRENGTHS
Tablets: Each 400 mg film-coated tablet is orange, capsule-shaped, and debossed with "P" on one side and "400" on the other side.
3CONTRAINDICATIONS
None
4ADVERSE REACTIONS
The following clinically important adverse reactions are described elsewhere in the labeling:
- Serious Infections
- Hepatotoxicity, Including Drug-Induced Liver Injury
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of WAYRILZ was evaluated in a randomized, double-blind (DB), placebo-controlled, parallel-group study (LUNA-3), in which 202 adult patients with persistent or chronic ITP received either WAYRILZ (n=133) or placebo (n=69)
During the 24-week DB period, the median duration of WAYRILZ exposure was 98 days (range: 22 to 182).
The most common adverse reactions (≥10%) were diarrhea, nausea, headache, abdominal pain, and COVID-19. Adverse reactions resulting in discontinuation of WAYRILZ included erythema nodosum, neutropenia, arthralgia, dyspepsia, headache, pain in extremity, abdominal discomfort, diarrhea, nausea, and pneumonia and occurred in 4.5% of patients.
Table 1 presents common adverse reactions from the LUNA-3 Study.
Specific Adverse Reactions
Gastrointestinal Events
In the LUNA-3 Study DB period, the most common gastrointestinal (GI) adverse reactions were diarrhea (32%), nausea (20%), and abdominal pain (14%) in the WAYRILZ group. These events were Grade 1 or 2. Of those who experienced GI adverse reactions, 2 patients discontinued due to GI adverse reactions. Recovery or resolution with supportive treatment allowing continuation of WAYRILZ treatment occurred in 91% of patients with diarrhea, 85% with nausea and 79% with abdominal pain.
Neutropenia
In the LUNA-3 Study DB period, Grade 1 or 2 neutropenia occurred in 11% of patients in the WAYRILZ group.
5OVERDOSAGE
In the event of overdosage, closely monitor the patient for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.
Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
6DESCRIPTION
WAYRILZ (rilzabrutinib) is a kinase inhibitor. Rilzabrutinib is a white to off-white solid, which is freely soluble in ethanol, sparingly soluble in isopropyl alcohol and practically insoluble in water.
The chemical name for rilzabrutinib is 1-Piperidinepropanenitrile, 3-[4-amino-3-(2-fluoro-4-phenoxyphenyl)-1
Each WAYRILZ film-coated tablet for oral administration contains 400 mg rilzabrutinib. The inactive ingredients in the tablet core are crospovidone (Type A), microcrystalline cellulose, and sodium stearyl fumarate. The inactive ingredients in the tablet coating are FD&C yellow #6/Sunset yellow FCF aluminum lake, macrogol/polyethylene glycol (PEG), polyvinyl alcohol partially hydrolyzed, talc, and titanium dioxide.
7CLINICAL STUDIES
Immune Thrombocytopenia (ITP)
The safety and efficacy of WAYRILZ in adult patients with primary persistent or chronic ITP was evaluated in a randomized, double-blind (DB), placebo-controlled, parallel-group study consisting of 24 weeks of blinded treatment followed by an open-label (OL) period [LUNA-3 Study (NCT04562766)]. Patients received an initial 12 weeks of DB period treatment. Those who achieved platelet count response at 12 weeks were eligible to continue the full 24-week DB period. The patients enrolled in this study had an unsustained response to either intravenous immunoglobulin (IVIg/anti-D) or corticosteroid (CS) or had a documented intolerance or insufficient response to any appropriate course of standard-of-care ITP therapy.
Patients were randomized 2:1 to receive WAYRILZ 400 mg or placebo twice daily and randomization was stratified based on prior splenectomy (yes/no) and severity of thrombocytopenia (platelet count <15 ×10
Concomitant ITP medicines [oral CS and/or thrombopoietin receptor agonist (TPO-RA)] were allowed at stable doses at least 2 weeks before the start of the study and throughout the DB period.
In the LUNA-3 Study, 202 patients were randomized and treated, 133 to the WAYRILZ group and 69 to the placebo group. At baseline, the median age was 47 years (range: 18 to 80 years), 63% were female, 62% were Caucasian, 32% Asian, 1% were Black or African American, 2% were American Indian or Alaska native, 20% were Hispanic or Latino/a, and 77% were not Hispanic or Latino/a. Baseline demographics were generally similar across groups with the exception of sex which was 59% female in the WAYRILZ group and 71% in the placebo group.
At baseline 93% of patients had chronic ITP (i.e., for 1 year or longer), with a median time since ITP diagnosis of 7.69 years (range: 0.3, 52.2), and 28% had undergone splenectomy. The median platelet count was 15.3 × 10
During the DB period, the median duration of exposure was 98 days (range: 22 to 182) and 84 days (range: 17 to 173) for the WAYRILZ group and placebo group, respectively. The cumulative duration of treatment exposure was 44 participant-years and 18 participant-years for the WAYRILZ and placebo groups, respectively. Concomitant use of CS and/or TPO-RA with study drug occurred in 60% and 67% of patients in the WAYRILZ and placebo arms, respectively.
During the first 12 weeks of the DB period, 85 (63.9%) patients and 22 (31.9%) patients in the WAYRILZ group and placebo group, respectively, achieved platelet count response (≥50 × 10
The efficacy of WAYRILZ was based on durable platelet response. A durable platelet response was defined as a weekly platelet count ≥50 × 10
The results of the major efficacy endpoints during the DB period are summarized in Table 2.
Rescue medication was required by 33% and 58% of patients receiving WAYRILZ and placebo, respectively. The median time to first use of rescue therapy was not reached in the WAYRILZ group and 56 days in the placebo group.
During the OL period, 7/73 (10%) patients who received WAYRILZ during the DB period achieved a durable response for the first time.
8HOW SUPPLIED/STORAGE AND HANDLING
The 400 mg WAYRILZ film-coated tablets are orange, capsule-shaped, and debossed with "P" on one side and "400" on the other side.
How Supplied:
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Storage Instructions
Instruct patients to store WAYRILZ at room temperature in the original package and to protect from light and moisture.
Administration Instructions
Instruct patients to take WAYRILZ orally twice daily at approximately the same time each day with or without food. Advise patients that WAYRILZ tablets should be swallowed whole with a glass of water, and not to cut, crush or chew the tablets
Missed Dose
Advise patients that if they miss a dose of WAYRILZ, they should take it as soon as possible on the same day and at least 2 hours apart from the next regular scheduled dose.
Drug Interactions
Advise patients to inform their healthcare providers of all concomitant medications, including over-the-counter medications, vitamins, and herbal supplements. Advise patients to avoid eating grapefruit, starfruit, and Seville oranges and products containing these fruits with WAYRILZ
Serious Infections
Advise patients of the possibility of serious infection, and to report any signs or symptoms
Hepatotoxicity, Including Drug-Induced Liver Injury
Inform patients that liver problems, including severe, life-threatening, or fatal hepatitis, DILI and abnormalities in liver tests, have occurred in patients treated with BTK inhibitors. Advise patients to contact their healthcare provider immediately if they experience abdominal discomfort, dark urine, or jaundice
Embryo-Fetal Toxicity
Advise female patients of reproductive potential that WAYRILZ may cause fetal harm and to inform their healthcare providers of a known or suspected pregnancy. Advise females of reproductive potential to use effective contraception during treatment with WAYRILZ and for 1 week after the last dose
Lactation
Advise women not to breastfeed during treatment with WAYRILZ and for at least 1 week after the final dose
10PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Carton
NDC 58468-0251-6
WAYRILZ™
60 tablets
11PRINCIPAL DISPLAY PANEL - 28 Tablet Blister Pack
NDC 58468-0251-0
Press and
WAYRILZ™
2
Each blister pack contains 28 tablets.
sanofi
12PRINCIPAL DISPLAY PANEL - 56 Tablet Blister Pack Carton
NDC 58468-0251-5
WAYRILZ™
Each carton contains a total of 56 tablets
sanofi
