Repotrectinib
NA
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Drug Status
Government Approvals
US(FDA)
WHO Essential Medicine
NO
Known Teratogen
NO
Pharmaceutical Class
Kinase Inhibitor
Controlled Drug Substance
No
Repotrectinib
Summary
Repotrectinib is used to treat specific types of non-small cell lung cancer and solid tumors that have certain gene fusions. It is indicated for adults with lung cancer that has spread and for adults and children aged 12 years and older with advanced or metastatic solid tumors.
Repotrectinib works by blocking certain proteins, specifically abnormal ones that signal cancer cells to multiply. This helps to slow down or stop the growth and spread of cancer cells.
For adults and children aged 12 years and older, the usual dose of Repotrectinib is 160 mg taken orally once daily for the first 14 days, then increased to 160 mg twice daily. The treatment continues until disease progression or unacceptable side effects occur.
Common side effects of Repotrectinib include dizziness, change in taste, peripheral neuropathy, constipation, and nausea. Serious adverse effects can include lung disease, liver toxicity, and skeletal fractures.
Important warnings for Repotrectinib include the risk of central nervous system effects, lung disease, liver toxicity, muscle pain, high levels of uric acid, and skeletal fractures. The medication should be discontinued if severe adverse reactions occur. It is contraindicated in patients with known hypersensitivity to the drug.
Indications and Purpose
How does Repotrectinib work?
Repotrectinib works by inhibiting certain proteins called kinases, specifically targeting abnormal proteins that drive cancer cell growth. By blocking these proteins, Repotrectinib helps to slow down or stop the proliferation of cancer cells, thereby controlling the spread of the disease.
Is Repotrectinib effective?
Repotrectinib has shown effectiveness in clinical trials, particularly in patients with ROS1-positive non-small cell lung cancer and NTRK gene fusion-positive solid tumors. The trials demonstrated significant overall response rates and duration of response, supporting its use in these conditions. Continued approval may depend on further confirmatory trials.
What is Repotrectinib?
Repotrectinib is used to treat certain types of non-small cell lung cancer and solid tumors with specific gene fusions. It belongs to a class of medications called kinase inhibitors, which work by blocking abnormal proteins that signal cancer cells to multiply, thereby slowing or stopping the spread of cancer.
Directions for Use
For how long do I take Repotrectinib?
Repotrectinib is typically used until the disease progresses or the patient experiences unacceptable toxicity. The exact duration varies based on individual response and tolerance to the medication.
How do I take Repotrectinib?
Repotrectinib should be taken orally, with or without food, at the same time each day. Swallow the capsules whole without crushing or chewing. Avoid consuming grapefruit or grapefruit juice while taking this medication, as it can affect how the drug works in your body.
How should I store Repotrectinib?
Repotrectinib should be stored at room temperature, between 68°F to 77°F (20°C to 25°C). Keep it in its original container, tightly closed, and away from light, excess heat, and moisture. Ensure it is out of reach of children to prevent accidental ingestion.
What is the usual dose of Repotrectinib?
For adults and children aged 12 years and older, the usual dose of Repotrectinib is 160 mg taken orally once daily for the first 14 days, then increased to 160 mg twice daily. The treatment continues until disease progression or unacceptable toxicity occurs.
Warnings and Precautions
Can I take Repotrectinib with other prescription drugs?
Repotrectinib interacts with strong and moderate CYP3A inhibitors and inducers, which can affect its concentration in the blood. It is advised to avoid these medications while taking Repotrectinib. Additionally, it can decrease the effectiveness of hormonal contraceptives, so alternative non-hormonal methods should be used.
Can Repotrectinib be taken safely while breastfeeding?
It is not known if Repotrectinib passes into breast milk. Due to the potential for serious adverse reactions in breastfed children, it is advised not to breastfeed during treatment and for 10 days after the last dose. Consult your healthcare provider for guidance on feeding your baby during this time.
Can Repotrectinib be taken safely while pregnant?
Repotrectinib can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use effective non-hormonal contraception during treatment and for 2 months after the last dose. Males with female partners of reproductive potential should use contraception during treatment and for 4 months after the last dose. There is no strong evidence from human studies, but animal studies have shown fetal malformations.
Is it safe to exercise while taking Repotrectinib?
Repotrectinib may cause dizziness, fatigue, and muscle weakness, which could limit the ability to exercise. If you experience these symptoms, it is advisable to avoid strenuous activities and consult your doctor for guidance on safe levels of physical activity while on this medication.
Is Repotrectinib safe for the elderly?
In clinical studies, there were no significant differences in safety and efficacy between patients younger than 65 years and those 65 years or older. However, elderly patients should be monitored closely for side effects, as they may be more susceptible to adverse reactions. Always consult a healthcare provider for personalized advice.
Who should avoid taking Repotrectinib?
Important warnings for Repotrectinib include the risk of central nervous system effects, interstitial lung disease, hepatotoxicity, myalgia with creatine phosphokinase elevation, hyperuricemia, and skeletal fractures. Patients should be monitored for these conditions, and the medication should be discontinued if severe adverse reactions occur. It is contraindicated in patients with known hypersensitivity to the drug.
