Active Ingredient: Zanubrutinib
Zanubrutinib as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Oral, 320 milligrams zanubrutinib, once daily.
Regimen B: Oral, 160 milligrams zanubrutinib, 2 times daily.
The recommended total daily dose of zanubrutinib is 320 mg. The daily dose may be taken either once daily or divided into two doses of 160 mg twice daily. Treatment with zanubrutinib should be continued until disease progression or unacceptable toxicity.
Recommended dose modifications of zanubrutinib for Grade 3 or greater adverse reactions are provided in the following table.
Recommended dose modifications for adverse reactions:
| Adverse reaction | Adverse reaction occurrence | Dose modification (starting dose: 320 mg once daily or 160 mg twice daily) |
|---|---|---|
| ≥Grade 3 non-haematological toxicities Grade 3 febrile neutropenia Grade 3 thrombocytopenia with significant bleeding Grade 4 neutropenia (lasting >10 consecutive days) Grad 4 thrombocytopenia (lasting >10 consecutive days) | First | Interrupt zanubrutinib Once toxicity has resolved to ≤Grade 1 or baseline: Resume at 320 mg once daily or 160 mg twice daily |
| Second | Interrupt zanubrutinib Once toxicity has resolved to ≤Grade 1 or baseline: Resume at 160 mg once daily or 80 mg twice daily | |
| Third | Interrupt zanubrutinib Once toxicity has resolved to ≤Grade 1 or baseline: Resume at 80 mg once daily | |
| Fourth | Discontinue zanubrutinib |
Asymptomatic lymphocytosis should not be regarded as an adverse reaction, and these patients should continue taking zanubrutinib.
A double dose should not be taken to make up for a forgotten dose. If a dose is not taken at the scheduled time, the next dose should be taken according to the normal schedule.
Zanubrutinib can be taken with or without food.
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