Action

The U.S. Food and Drug Administration (FDA) approved Wayrilz (rilzabrutinib) tablets to treat adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to immunoglobulins, anti-D therapy, or corticosteroids.

Disease or Condition

ITP is a disease that can lead to bruising or bleeding and is characterized by a low count of platelets (blood clotting cells).

Effectiveness

Wayrilz’s safety and efficacy was evaluated in a 24-week, double-blind, parallel-group study looking at durable platelet response (i.e., an increased number of platelets from baseline lasting the majority of the last 12 weeks of the treatment period). In this study, 202 patients were randomly assigned to either the Wayrilz group (133) or placebo group (69). During the 24-week treatment period, 31 (23%) patients in the Wayrilz group and no patients in placebo group achieved a sufficient and durable platelet count response, as determined by the study.

Safety Information

Wayrilz may increase the risk of serious infections (including bacterial, viral, or fungal). The most common side effects were diarrhea, nausea, headache, abdominal pain, and COVID-19.

The recommended dosage is 400 mg taken orally twice daily. Patients who experience gastrointestinal symptoms should consider taking Wayrilz with food to improve tolerability. Patients should swallow the pill whole with a glass of water; the pill should not be cut, crushed, or chewed.