The use of zanubrutinib in special populations necessitates individualized adjustments based on each patient’s condition, with critical focus on safety profiles in patients with hepatic/renal dysfunction, pregnant or lactating women, and elderly individuals. Specific precautions are detailed below:
Elderly Patients
Dose adjustment is generally unnecessary. However, elderly patients often present with comorbidities or diminished hepatic/renal function, requiring close monitoring for adverse reactions (e.g., infections, hemorrhage, cytopenia).
An individualized treatment plan should be formulated by a physician after evaluating the patient’s overall health status and concomitant medications.
Patients with Hepatic or Renal Impairment
Hepatic Impairment
Dose reduction is required for patients with mild or moderate impairment (Child-Pugh Class A or B).
Use is contraindicated in patients with severe impairment (Child-Pugh Class C).
Renal Impairment
Dose adjustment is generally unnecessary for patients with mild or moderate impairment (eGFR ≥ 30 mL/min).
Caution is advised and dose adjustment under physician supervision is recommended for patients with severe impairment (eGFR < 30 mL/min) or those undergoing dialysis.
Pregnant and Lactating Women
Contraindicated during pregnancy
Zanubrutinib may cause fetal harm. Effective contraception must be implemented during treatment and for at least 1 week following drug discontinuation.
Avoid use during lactation
No data are available regarding the excretion of zanubrutinib in human milk. Breastfeeding is recommended to be suspended during treatment and for 2 weeks after the last dose.
Pediatric and Adolescent Patients
Safety and efficacy have not been established in this population. Use is not recommended in patients under 18 years of age.
Additional Precautions
Close monitoring is required for patients at risk of bleeding or receiving anticoagulant therapy.
Administration of live vaccines is contraindicated during treatment.
Immediate medical attention and treatment regimen adjustment are mandatory if serious adverse reactions (e.g., atrial fibrillation, severe infection) occur.
All medications must be administered strictly under medical guidance. Prior to treatment, patients should disclose their full medical history and current medications to their physician, and undergo regular follow-up assessments to evaluate treatment efficacy and safety.
