Repotrectinib

On November 15, 2023, Repotrectinib received FDA approval for marketing, providing a new treatment option for ROS1 positive NSCLC patients. 

The Lucius version of Repotrectinib has a drug specification of 40mg/60capsules, which fully considers the convenience and compliance of patients' medication. Patients can take the prescribed dosage and frequency according to the doctor's prescription and advice.

Repotrectinib is a targeted therapy drug mainly used to treat certain types of cancer, especially those patients who no longer respond to other treatment methods or have already relapsed. It works by inhibiting specific cancer cell growth signaling pathways, slowing down or preventing cancer progression.

1.Main components

Repotrectinib

2.Adapt to the population

Repotrectinib is indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). 

3.Medication for special populations

3.1Pregnancy

There are no available data on Repotrectinib use in pregnant women.Advise pregnant women of the potential risk to a fetus.

3.2Lactation

There are no data on the presence of Repotrectinib in human milk or its effects on either the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children from Repotrectinib, advise a lactating woman to discontinue breastfeeding during treatment with Repotrectinib and for 10 days after the last dose.

3.3Females and Males of Reproductive Potential

Advise females of childbearing potential to use effective non-hormonal contraception during treatment with Repotrectinib and for 2 months following the last dose. Repotrectinib can render some hormonal contraceptives ineffective.

Advise male patients with female partners of childbearing potential to use effective contraception during treatment with Repotrectinib and for 4 months following the last dose.

3.4Pediatric Use

The safety and effectiveness of Repotrectinib in pediatric patients with ROS1-positive NSCLC has not been established.

3.5Geriatric Use

There were no clinically meaningful differences in safety and efficacy between patients younger than 65 years of age and patients 65 years of age or older.

3.6Renal Impairment

The recommended dosage of Repotrectinib has not been established in patients with severe renal impairment or kidney failure and patients on dialysis .

No dosage modification is recommended for patients with mild or moderate renal impairment .

3.7Hepatic Impairment

The recommended dosage of Repotrectinib has not been established in patients with moderate or severe hepatic impairment .

No dosage modification is recommended for patients with mild hepatic impairment.

4.Drug overdose

Drug overdose is not yet clear.

5.Drug storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). 

6.Pharmacokinetics

The geometric mean (CV%) absolute bioavailability of repotrectinib is 45.7% (19.6%).

from FDA，2023.11