Medical Information

Zongertinib is an innovative drug for targeted treatment of NTRK gene fusion positive solid tumors, with clear indications and strict adherence to precautions. The following is a systematic exposition from two aspects: approved indications and core precautions, providing reference for rational drug use in clinical practice.

1. Indications

(1) Main indications

Suitable for the treatment of locally advanced or metastatic solid tumors with positive fusion of neurotrophic tyrosine receptor kinase (NTRK) gene in adults and children over 12 years old.

(2) Applicable conditions

The NTRK gene fusion status needs to be confirmed through FDA approved testing methods, and the patient does not have satisfactory alternative treatment options or previous treatment failures.

2. Medication precautions

(1) Neurological effects

May cause dizziness (incidence rate of 27%) and ataxia. During medication, avoid driving or operating precision equipment, and adjust the administration time to bedtime if necessary.

(2) Hepatotoxicity monitoring

ALT/AST testing every 2 weeks during the first month of treatment, followed by monthly follow-up; If liver injury of grade ≥ 3 occurs, medication should be suspended until it recovers to grade ≤ 1.

(3) Birth risk control

Women of childbearing age need to confirm their pregnancy status before taking medication, and non hormonal contraceptive measures should be taken during treatment and 2 months after the last dose.

(4) Drug interactions

Combination therapy with potent CYP3A4 inhibitors requires a 50% reduction in dosage. Combination therapy with inducers may reduce efficacy and should be avoided.

(5) Adjustment for special populations

Patients with liver dysfunction need to adjust their dosage according to Child Pugh grading; Breastfeeding should be suspended for 10 days after the last administration.