Repotrectinib(Augtyro)

Reprotinib is a prescription drug targeting ROS1 and NTRK1/2/3. It was approved in the United States in November 2023 for the treatment of adult patients with ROS1‑positive locally advanced or metastatic non‑small cell lung cancer. On June 13, 2024, it received additional FDA approval for the treatment of NTRK‑positive locally advanced or metastatic solid tumors. Use this medication strictly under the guidance of a physician.

Target of Action

ROS1, NTRK1/2/3

Dosage and Administration

Route and frequency of administration of Repotrectinib: Oral, once daily during the initial phase.

The dose of Repotrectinib should be adjusted according to the patient's actual condition. For specific details, consult a physician and follow medical advice.

Recommended reading: Dosage and Administration of Repotrectinib

Side Effects

Common side effects: Dizziness, dysgeusia, peripheral neuropathy, etc.

Serious side effects: Central nervous system (CNS) problems, lung problems (pneumonia), liver problems, etc.

Reference article: Side Effects of Repotrectinib

Use in Specific Populations

Pregnancy: When administered to pregnant women, it may cause fetal harm. Pregnant women should be informed of the potential risk to the fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with Repotrectinib and for 2 months after the last dose, because Repotrectinib can render certain hormonal contraceptives ineffective.

Lactation: Do not breastfeed during treatment and for 10 days after the last dose of Repotrectinib. It is unknown whether Repotrectinib passes into breast milk.

Daily Precautions

1. Instruct patients to swallow Repotrectinib capsules whole, with or without food.

2. Inform patients that if a dose of Repotrectinib is missed or vomiting occurs after taking a dose, the missed or vomited dose should be skipped and the next dose should be taken at the next scheduled time.

3. Instruct patients to inform their clinician if they experience new or worsening central nervous system symptoms (e.g., dizziness, vertigo, ataxia, mood changes, cognitive impairment). Advise patients not to drive or operate hazardous machinery if they experience central nervous system adverse reactions.

from FDA，2023.11