Chokri Ben Lamine: Rilzabrutinib – Oral BTK Inhibitor for ITP
Chokri Ben Lamine, Hematologist at King Faisal Specialist Hospital and Research Center, shared a post on X:
“Rilzabrutinib (Wayrilz): oral BTK inhibitor for ITP
FDA-approved for adults with persistent or chronic immune thrombocytopenia who have had an insufficient response to previous treatment.
Mechanism: A reversible covalent Bruton tyrosine kinase inhibitor. It inhibits B-cell activation and Fcγ receptor–mediated phagocytosis, reducing immune destruction of antibody-coated platelets.
Dose: 400 mg orally twice daily, with or without food. Swallow tablets whole; food may improve gastrointestinal tolerability.
LUNA3 phase III trial — 202 previously treated adults
- Durable platelet response: 23% versus 0% with placebo; P less than 0.0001.
- Response required sustained platelets 50 × 10⁹/L or more during the final 12 weeks, without rescue therapy.
- Benefits also included reduced rescue treatment and improvements in bleeding and fatigue.
- Interpretation: The 23% represents a stringent durable-response endpoint, rather than the proportion experiencing any platelet improvement.
Practical prescribing points
- Common adverse effects: diarrhea 32%, nausea 20%, headache 18%, abdominal pain 14%.
- Monitor for serious infections.
- Check bilirubin or transaminases before treatment and as clinically indicated. Withhold for suspected drug-induced liver injury; discontinue if confirmed.
- Avoid moderate or strong CYP3A inhibitors or inducers and proton pump inhibitors.
- Give rilzabrutinib 2 hours or more before antacids or H₂ blockers.
- It also inhibits CYP3A: review interacting medications.
- Avoid in severe renal impairment or Child–Pugh B and C hepatic impairment.
- Pregnancy testing and effective contraception are required where applicable.
FDA prescribing information, LUNA3 publication—Blood.”
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