Initial US Approval:
2025
Key Clinical Studies:
LUNA 3
Drug Class/Description:
novel oral, reversible, Bruton’s tyrosine kinase (BTK) inhibitor
Indications and Usage:
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.
Dosage and Administration:
- 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.
Dosage Forms and Strengths:
Tablets: 400 mg
Contraindications:
None.
Warnings and Precautions:
- 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.
Adverse Reactions:
Most common adverse reactions (incidence ≥10%) were diarrhea, nausea, headache, abdominal pain, and COVID-19.
Drug Interactions:
- 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.
Use in Specific Populations:
- Lactation: Advise not to breastfeed.
- Hepatic Impairment: Avoid use of WAYRILZ in patients with moderate or severe hepatic impairment.
- Renal Impairment: Avoid use in patients with severe renal impairment.
Adapted From:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219685s000lbl.pdf
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
