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Repotrectinib is the third pan-solid tumor therapy after larotinib and entrectinib, providing new good news for patients with ROS1-positive NSCLC.
1. Generic name: Repotrectinib
2. Trade name: AUGTYRO
3. English name: Repotrectinib
This product is suitable for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
This product is a 40 mg capsule.
1. Active ingredient: reprotinib.
2. Excipients: microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, colloidal silica. The capsule shell contains gelatin and titanium dioxide. Printing ink contains shellac and FD&C Blue No. 2 aluminum lake.
1. Recommended dosage: Take 160 mg (4 40 mg capsules) orally once a day for the first 14 days; then increase to 160 mg twice a day until disease progression or unacceptable toxicity occurs.
2. How to take: It can be taken with a meal or on an empty stomach. Tablets should be swallowed whole and not opened, chewed, crushed or dissolved. Take the medicine at approximately the same time every day.
1. Dose adjustment is based on the severity of adverse reactions. Recommended dose levels are: reduce the first dose to 120 mg (once or twice daily) and the second dose to 80 mg (once or twice daily).
2. Central nervous system reactions: For intolerable grade 2 or 3 reactions, suspend administration until improvement to ≤ grade 1 or baseline level, and then resume at the same or reduced dose; for grade 4 reactions, permanently discontinue the drug.
3. Interstitial lung disease/pneumonia: If suspected at any level, the drug will be suspended; if confirmed, the drug will be permanently discontinued.
4. Hepatotoxicity: Depending on the level of elevation of transaminases and bilirubin, measures should be taken to suspend, reduce the dose, or permanently discontinue the drug.
5. Elevation of creatine phosphokinase: Depending on the degree of increase, suspend administration until recovery, and then resume at the same or reduced dose.
6. Hyperuricemia: Suspension of administration when grade 3 or 4 occurs, and resume at the same or reduced dose after improvement.
7. Other clinically relevant adverse reactions: For intolerable Grade 2, Grade 3 or Grade 4 reactions, suspend administration until improvement, then resume at the same or reduced dose or permanently discontinue.
1. Medication time: Take it at roughly the same time every day, with food or on an empty stomach.
2. Missed dose or vomiting: If you miss a dose or vomit after taking the medicine, you should not take it again, but should take the regular dose at the next scheduled time. Two doses should not be taken at the same time to make up for a missed dose or vomited dose.
1. Pregnant women: Based on the mechanism of action and animal data, this product can cause fetal harm and is contraindicated in pregnant women. Women of childbearing potential need to use effective non-hormonal contraceptive methods during treatment and within 2 months after the last dose (because this product can render some hormonal contraceptives ineffective).
2. Breastfeeding women: It is recommended that women stop breastfeeding during treatment and within 10 days after the last dose.
3. Men of childbearing age: It is recommended that men with female partners of childbearing potential use effective contraceptive measures during treatment and within 4 months after the last dose.
4. Children: The safety and effectiveness in pediatric patients with ROS1-positive NSCLC have not been determined.
5. Elderly patients: No clinically significant differences in safety or efficacy were observed compared with younger patients.
6. Hepatic/renal insufficiency: Patients with mild liver damage or mild to moderate renal impairment do not need to adjust the dose. Recommended dosages for patients with moderate or severe hepatic impairment, severe renal impairment, or renal failure have not been established.
1. The most common adverse reactions (≥20%) include: dizziness, dysgeusia, peripheral neuropathy, constipation, dyspnea, ataxia, fatigue, cognitive impairment, and muscle weakness.
2. Serious adverse reactions that require vigilance: central nervous system reactions (such as dizziness, ataxia, cognitive impairment), interstitial lung disease/pneumonitis, hepatotoxicity, myalgia with elevated creatine phosphokinase, hyperuricemia, and bone fractures.
There are currently no obvious contraindications.
1. Strong and moderate CYP3A inhibitors: Avoid simultaneous use. Before starting treatment with this product, strong or moderate CYP3A inhibitors need to be discontinued for 3-5 half-lives.
2. P-glycoprotein inhibitors: avoid simultaneous use.
3. Strong and moderate CYP3A inducers: Avoid simultaneous use.
4. Certain CYP3A4 substrates: Avoid combination with CYP3A substrates with narrow therapeutic windows, because this product may reduce its plasma concentration, resulting in a decrease in efficacy.
5. Hormonal contraceptives: Avoid simultaneous use, as this product will reduce its efficacy. Effective non-hormonal contraceptive methods should be used.
6. Grapefruit products: Avoid eating them during treatment, as they may increase the blood concentration of this product.
Storage at 20℃ to 25℃ (68℉ to 77℉); short-distance transportation allowed between 15℃ to 30℃ (59℉ to 86℉).