Medical Information

The usage and dosage of Repotrectinib should be adjusted according to the patient type and adverse reactions. Special attention should be paid to pregnancy, lactation, and liver and kidney dysfunction when using it for special populations. The following provides a detailed explanation from three aspects: standard dosage regimen, dosage adjustment principles, and medication for special populations, covering differentiated medication guidance for adult and pediatric patients.

1. Standard Dose Protocol

(1) Adult patients: Take 160mg orally once daily for the initial 14 days, then increase to 160mg twice daily until disease progression or intolerable toxicity occurs.

(2) Pediatric patients: Solid tumor patients aged 12 and above are treated with the same dosage regimen as adults, and the safety of NTRK gene fusion patients under 12 years old has not been established.

2. Principle of dose adjustment

(1) Adverse reaction adjustment

Central nervous system symptoms: intolerable level 2 suspension to the original dose or reduction after recovery, level 3 requires reduction, and level 4 requires permanent discontinuation of medication.

Hepatotoxicity: Within 4 weeks after a pause of grade 3, the dosage can be restored to its original level. For recurrent grade 3 or 4, the dosage should be reduced or discontinued.

(2) Step wise reduction plan

First reduction: once daily to 120mg, twice daily to 120mg x 2; The second reduction corresponds to a decrease to 80mg or 80mg × 2.

3. Medication for special populations

(1) Pregnant women

Animal studies have shown teratogenic risks, and pregnancy status should be confirmed before medication. Effective non hormonal contraceptive measures should be used during treatment.

(2) Lactating women

The data on drug milk secretion is unknown. It is recommended to suspend breastfeeding during the treatment period and within 10 days after the last administration.

(3) Liver dysfunction

Mild abnormalities do not require adjustment, and the dosage for patients with moderate to severe liver dysfunction has not been established and requires close monitoring.

(4) Renal insufficiency

Mild to moderate patients do not require adjustment, and the recommended dosage for severe renal insufficiency or dialysis patients is not yet clear.

(5) Elderly patients

There is no significant difference in efficacy and safety between patients aged 65 and above and the younger population, and conventional dosage is sufficient.