Rezabrutinib is a highly selective BTK inhibitor indicated for various B-cell hematologic malignancies.

I. Indications

This product is indicated for the treatment of the following B-cell malignancies in adults:

1. Waldenström's macroglobulinemia: For patients who have received at least one prior therapy, or as first-line treatment for patients who are not candidates for chemoimmunotherapy.

2. Marginal zone lymphoma: For patients who have progressed after at least one anti-CD20 monoclonal antibody therapy.

3. Chronic lymphocytic leukemia/small lymphocytic lymphoma: Can be used in treatment-naïve or relapsed/refractory patients.

4. Follicular lymphoma: In combination with obinutuzumab, for patients with relapsed or refractory disease after at least two prior systemic therapies.

5. Treatment should be continued until clear evidence of disease progression or unacceptable toxicity. Patients should not discontinue treatment on their own, as this may lead to rapid disease rebound.

II. Contraindications

1. Absolute contraindications

(1) Hypersensitivity to the active ingredient (zanubrutinib) or any excipients (such as microcrystalline cellulose, lactose, magnesium stearate, etc.) is contraindicated.

(2) Hypersensitivity reactions may manifest as rash, dyspnea, angioedema, etc.

2. Conditions to avoid or use with caution

(1) Severe active infection: In the presence of uncontrolled systemic infection (including active hepatitis B, hepatitis C, or tuberculosis), treatment should be postponed until the infection is effectively controlled and then reassessed.

(2) Recent major surgery: Treatment may increase perioperative bleeding risk. The drug should be withheld 3-7 days before major surgery (including dental surgery), and the timing of resumption should be based on postoperative bleeding risk assessment.

(3) Severe bleeding tendency: Patients with a history of spontaneous bleeding or coagulopathy (e.g., hemophilia A/B, von Willebrand disease) are contraindicated. If unexplained hematuria, black stools, or severe headache occur, seek immediate medical attention.

(4) Coadministration with strong CYP3A inducers: Drugs such as rifampin, carbamazepine, phenytoin, St. John's wort, etc., significantly reduce blood concentrations of this drug, potentially leading to loss of efficacy. Concomitant use should be avoided.

III. Prohibited Foods

1. Grapefruit (pomelo) and its juice:

(1) Furanocoumarin compounds in grapefruit strongly inhibit intestinal CYP3A enzymes, which may increase rezabrutinib blood concentrations and elevate the risk of serious adverse reactions such as bleeding and arrhythmias.

(2) Completely avoid during treatment and for 3 days after discontinuation.

2. Sour orange (Seville orange):

Also contains CYP3A-inhibiting components, commonly found in some marmalades and juice drinks. Should also be avoided.

3. Star fruit:

Neurotoxins and CYP enzyme inhibitors in star fruit may interfere with drug metabolism and increase the risk of neurotoxicity and other adverse reactions. Avoidance is recommended.