Entrectinib (Entrectinib) Medication Precautions
1. Administration
Entrectinib (Entrectinib) may be taken with or without food. Swallow capsules whole; do not open, crush, chew, or dissolve the capsule contents.
2. Missed Dose
If a dose is missed and it is more than 12 hours until the next scheduled dose, take the missed dose as soon as possible. If it is less than 12 hours until the next dose, skip the missed dose.
3. Vomiting
If the patient vomits immediately after taking the dose, instruct them to repeat the dose.
Entrectinib (Entrectinib) Use in Special Populations
1. Renal Impairment
(1) Mild or moderate renal impairment (creatinine clearance CrCl 30 to<90 ml="">
(2) Severe renal impairment (creatinine clearance CrCl<30 ml="">
2. Hepatic Impairment
(1) Grade 3 liver injury: Withhold until recovery to ≤ grade 1 or baseline. If the adverse reaction resolves within 4 weeks, resume at the same dose. If not resolved within 4 weeks, permanently discontinue. For recurrent grade 3 events that resolve within 4 weeks, resume at a reduced dose.
(2) Grade 4 liver injury: Withhold until recovery to ≤ grade 1 or baseline. If the adverse reaction resolves within 4 weeks, resume at a reduced dose. If not resolved within 4 weeks, permanently discontinue. For recurrent grade 4 events, permanently discontinue.
(3) ALT or AST >3× ULN with concurrent total bilirubin >1.5× ULN (excluding cholestasis or hemolysis): Permanently discontinue.
3. Pediatric Use
(1) Safety and efficacy in pediatric patients under 12 years of age with NTRK gene fusion-positive solid tumors have not been established.
(2) Safety and efficacy in patients under 18 years of age with ROS1-positive non-small cell lung cancer (NSCLC) have not been established.
4. Dialysis
No data available.
Entrectinib (Entrectinib) Dose Reduction Scheme for Adverse Reactions
1. First Dose Reduction
(1) Adults and pediatric patients aged ≥12 years with body surface area (BSA) >1.50 m²: 400 mg orally once daily.
(2) Pediatric patients aged ≥12 years with BSA 1.11 to 1.50 m²: 400 mg orally once daily.
(3) Pediatric patients aged ≥12 years with BSA 0.91 to 1.10 m²: 300 mg orally once daily.
2. Second Dose Reduction
(1) Adults and pediatric patients aged ≥12 years with BSA >1.50 m²: 200 mg orally once daily.
(2) Pediatric patients aged ≥12 years with BSA 1.11 to 1.50 m²: 200 mg orally once daily.
(3) Pediatric patients aged ≥12 years with BSA 0.91 to 1.10 m²: 200 mg orally once daily.
3. Third Reduction
If the patient cannot tolerate the dose after the second reduction, permanently discontinue.
