Instructions for Zanubrutinib

1. Name: Zanubrutinib Capsules, BRUKINSA

2. Indications:

1. Mantle cell lymphoma (MCL): Zanubrutinib (Zanubrutinib) is suitable for the treatment of adult patients with mantle cell lymphoma who have received at least one previous treatment.

2. Macroglobulinemia (WM): Zanubrutinib is indicated for the treatment of adult patients with Waldenström's macroglobulinemia.

3. Marginal zone lymphoma (MZL): Zanubrutinib is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least one anti-CD20-based regimen.

4. Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL): Zanubrutinib is suitable for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

3. Usage and dosage:

1. Recommended dose: The recommended dose of zanubrutinib is 160 mg orally twice daily, or 320 mg orally once daily, until disease progression or unacceptable toxicity occurs.

2. Dosage adjustment:

(1) Patients with hepatic impairment: The recommended dose for patients with severe hepatic impairment is 80 mg orally twice daily;

(2) Drug interactions: When coadministered with strong CYP3A inhibitors, the dose is reduced to 80 mg orally once daily; when coadministered with moderate CYP3A inhibitors, the dose is reduced to 80mg orally twice daily; avoid coadministration with strong CYP3A inducers; also avoid coadministration with moderate CYP3A inducers, if unavoidable, increase the dose to 320 mg orally twice daily.

(3) Asymptomatic lymphocytosis should not be considered an adverse reaction, and these patients should continue taking zanubrutinib.

4. Adverse reactions:

The most common adverse effects of zanubrutinib are neutropenia(low levels of neutrophils, a type of white blood cell), upper respiratory tract infection (infection of the nose and throat), bleeding, bruising, rash, and musculoskeletal pain; The most common serious side effects are neutropenia and pneumonia(pulmonary infection), hypertension and thrombocytopenia.

5. Storage:

Zanubrutinib will be stored at 20°C to 25°C (68°F to 77°F); excursions allowed between 15°C and 30°C (59°F to 86°F).

6. Special groups:

1. Women: According to the results of animal studies, taking zanubrutinib by pregnant women can cause harm to the fetus. It is recommended that female patients of childbearing potential use effective contraceptive measures during treatment with zanubrutinib and within 1 week after the last dose of Bruginsa; lactating women should not breastfeed during treatment with zanubrutinib and within two weeks after the last dose.

2. Men: It is recommended that men avoid childbirth while receiving zanubrutinib and within one week after the last treatment.

7. Mechanism of action:

Zanubrutinib is a small molecule inhibitor of Bruton tyrosine kinase (BTK). Zanubrutinib forms covalent bonds with cysteine u200bu200bresidues in the active site of BTK, resulting in inhibition of BTK activity. BTK is a signaling molecule of the B cell antigen receptor (BCR) and cytokine receptor pathways. InB cells, BTK signaling leads to the activation of pathways necessary for B cell proliferation, trafficking, chemotaxis, and adhesion. In nonclinical studies, zanubrutinib inhibited malignant B cell proliferation and reduced tumor growth.