硫酸拉罗替尼胶囊Larotrectinib sulfate 100mg

Indicated for adult and pediatric patients with locally advanced or metastatic solid tumors harboring neurotrophic receptor tyrosine kinase (NTRK) gene fusions, who meet the following criteria: The disease has progressed after prior treatment, or no suitable standard treatment options are available. The applicable cancer types include lung cancer, thyroid cancer, colorectal cancer, sarcoma, breast cancer and other solid tumors. The core advantage of this product is its tumor-agnostic property.

NTRK gene fusions lead to the expression of abnormal TRK proteins, which continuously activate cell proliferation signaling pathways and promote tumorigenesis and progression. Larotrectinib sulfate can specifically bind to and inhibit the activity of abnormal TRK proteins, block downstream signal transduction, thereby inhibiting the growth and proliferation of tumor cells and inducing tumor cell apoptosis.

Adults and pediatric patients aged 12 years and older: The recommended dose is 100 mg orally twice daily, with or without food. Pediatric patients under 12 years of age: The dose needs to be calculated based on body surface area; specific dosage shall be in accordance with the physician’s instructions. Swallow the tablets whole. Do not chew, crush or split the tablets. If a dose is missed, do not make up for the missed dose and take the next dose as originally scheduled.

Common Adverse Reactions Fatigue, nausea, vomiting, constipation, diarrhea, dizziness, cough, anemia, myalgia, arthralgia, etc. Most of these reactions are mild to moderate (Grade 1–2). Severe Adverse Reactions Central nervous system toxicity (e.g., cognitive impairment, hallucinations, ataxia), hepatic toxicity, musculoskeletal toxicity (e.g., rhabdomyolysis) may occur, requiring timely monitoring.

Avoid concomitant use with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole), which may increase the plasma concentration of larotrectinib and raise the risk of adverse reactions. If concomitant use is unavoidable, the dose of larotrectinib needs to be reduced. Avoid concomitant use with potent CYP3A4 inducers (e.g., rifampicin, carbamazepine), which may decrease the plasma concentration of larotrectinib and affect its efficacy.

Hepatic Impairment: No dose adjustment is required for patients with mild to moderate hepatic impairment. Use with caution in patients with severe hepatic impairment and conduct close monitoring. Renal Impairment: No dose adjustment is required for patients with mild to moderate renal impairment. Monitor for adverse reactions in patients with severe renal impairment. Pediatric Patients: For children under 12 years of age, dosage is based on body surface area; the safety and efficacy have been confirmed. Pregnancy and Lactation: Use during pregnancy may cause fetal harm. Females of reproductive potential should use effective contraceptive measures during treatment and for 1 week after discontinuation. Lactating women should discontinue breastfeeding.

Store in a sealed container, in a dry place below 25℃. Short-term exposure to temperature fluctuations between 15–30℃ is acceptable. Avoid direct sunlight and humid environments. Keep out of the reach of children.