Tirabrutinib is an oral BTK inhibitor metabolized by hepatic CYP3A. The medication risk is significantly increased in patients with severe hepatic impairment and active bleeding, who belong to the population requiring avoidance or strict evaluation. They are described separately below.

I. Patients with severe hepatic impairment

Risk mechanism: This product is mainly metabolized by the liver. In severe hepatic impairment, drug clearance is slowed and exposure is increased, raising the risk of toxicity.

Medication principle: It should be avoided in patients with severe hepatic impairment (such as Child-Pugh class C); for those with moderate impairment, the dose should be reduced after physician evaluation and closely monitored.

Monitoring requirements: Recheck liver function regularly during medication, paying attention to changes in transaminases and bilirubin.

Alert manifestations: Seek medical attention immediately when jaundice, dark urine, marked fatigue, decreased appetite, or right upper abdominal discomfort occurs.

Concomitant medication: Avoid simultaneous use of strong CYP3A inhibitors (such as ketoconazole and clarithromycin) to prevent further increases in blood drug concentration.

II. Patients with active bleeding

Risk mechanism: BTK inhibitors can affect platelet function, inhibit platelet aggregation, and increase bleeding tendency.

Contraindicated situations: Use should be avoided or suspended in those with active bleeding (such as gastrointestinal bleeding, intracranial hemorrhage, and obvious hemoptysis).

Populations requiring caution: Those with a history of bleeding disorders, significantly reduced platelets, or recent major surgery require careful evaluation.

Warning on concomitant medication: Avoid self-administration of antiplatelet or anticoagulant drugs such as aspirin, warfarin, and clopidogrel; when concomitant use is truly necessary, it should be weighed by a physician with enhanced monitoring.

Surgery and tooth extraction: Inform the physician of the medication situation before surgery; this product usually needs to be suspended several days in advance.

Signals to seek medical attention: Seek medical attention immediately when melena, hematuria, persistent epistaxis, large bruises, or unexplained anemia occurs.

III. Common precautions

Before medication, both populations should complete evaluations of liver function, complete blood count, and coagulation function.

During treatment, regularly monitor blood counts and liver function, and adjust the regimen promptly when abnormalities occur.

Any dose adjustment or discontinuation must follow the physician's instructions and must not be decided on one's own.

Actively inform the physician that this product is being taken during medical visits to facilitate comprehensive judgment.