Wayrilz (Rilzabrutinib) instructions in Chinese

1. Name:Wayrilz, Rilzabrutinib

2. Indications:

Wayrilz (Rilzabrutinib) is indicated for the treatment of adult patients with persistent or chronic immune thrombocytopenia (ITP) who have had an inadequate response to prior therapy.

3. Usage and dosage:

1. Before use: Before starting treatment with Wayrilz, verify the pregnancy status of females of reproductive potential.

2. Recommended dose:The recommended dose of Wayrilz is 400 mg, taken orally twice a day. Wayrilz can be taken at approximately the same time each day with or without food. In patients experiencing gastrointestinal symptoms, taking Wayrilz with food may improve tolerability.

If a dose is missed, patients should take the missed dose of Wayrilz on the same day as soon as possible and at least 2 hours after the next regularly scheduled dose. If you are taking antacids or histamine H2 receptor antagonists, take Wayrilz at least 2 hours before taking the antacid or histamine H2 receptor antagonist.

3. Dose adjustment: Assess bilirubin and aminotransferases at baseline, and clinical indications during Wayrilz treatment. Patients who develop liver function abnormalities after treatment with Wayrilz should be monitored more frequently for liver function abnormalities and clinical signs and symptoms of hepatotoxicity. If drug-induced liver injury (DILI) is suspected, Wayrilz should be discontinued. Once DILI is confirmed, stop Wayrilz.

4. Adverse reactions:

In clinical studies of Wayrilz, the most common adverse reactions (≥10%) were diarrhea, nausea, headache, abdominal pain and COVID-19. Adverse reactions leading to discontinuation of Wayrilz include erythema nodosum, neutropenia, arthralgia, dyspepsia, headache, extremity pain, abdominal discomfort, diarrhea, nausea, and pneumonia.

5. Storage:

Wayrilz tabletsinStore at room temperature, 20°C to 25°C (68°F to 77°F); excursions allowed between 15°C to 30°C (59°F to 86°F). Store and distribute in original packaging. Protect from light and moisture.

6. Special groups:

1. Women: According to preliminary animal data, pregnant women taking WAYRILZ may cause harm to the fetus. Therefore, it is recommended that female patients of reproductive potential use effective contraception during treatment and for 1 week after stopping treatment; lactating women should not breastfeed during treatment and for at least 1 week after the last dose of the drug.

7. Mechanism of action:

Rilzabrutinib is a small molecule, covalent, reversible kinase inhibitor targeting Bruton's tyrosine kinase (BTK). Rilzabrutinib mediates its therapeutic effect in ITP through immunomodulation, including 1) inhibitingB cell activation, and 2) blocking the phagocytosis of antibody-coated cells by Fcγ receptors (FcγR) in the spleen and liver. In vitro, Rilzabrutinib reduces autoantibody signaling mediated through the FcγR pathway, blocks B cell signaling, and reduces autoantibody production by affecting B cell activation.

8. Overdose:

In the event of overdose, monitor patients closely for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment promptly.

Reference materials:https://go.drugbank.com/drugs/DB17709