Larotrectinib Capsules LOXO-101 Vitrakvi LuciLaro 100mg

Product Name: LuciLaro

Chinese Name: Larotrectinib

English Name: Larotrectinib

[Overview]

Larotrectinib is a multi-targeted anti-cancer drug indicated for the treatment of TRK fusion-positive solid tumors, as well as various other cancers such as lung cancer, thyroid cancer, melanoma, gastrointestinal cancer, colon cancer, and prostate cancer. By inhibiting the activity of TRK fusion proteins, Larotrectinib blocks the growth and proliferation of tumor cells, thereby helping patients combat cancer.

[Indications]

Larotrectinib is a broad-spectrum anti-cancer drug effective against a wide variety of tumors. It is effective in treating 17 different types of tumors, including lung cancer, thyroid cancer, melanoma, gastrointestinal cancer, colon cancer, soft tissue sarcoma, salivary gland cancer, infantile fibrosarcoma, appendiceal cancer, breast cancer, bile duct cancer, and pancreatic cancer.

[Specification] 100 mg/capsule; 30 capsules/box

[Dosage and Administration]

Adults: The recommended dosage of Larotrectinib for adults is 100 mg taken orally twice daily, continued until disease progression or the occurrence of unacceptable toxicity.

Pediatric Patients (Dosage based on age and weight): For pediatric patients with a body surface area (BSA) of less than 1.0 m², the recommended dosage of Larotrectinib is 100 mg/m², taken orally twice daily, with or without food.

Dosage Adjustments for Adverse Reactions: In the event of Grade 3 or 4 adverse reactions, reduce the dosage until the reaction improves or resolves to Grade 1. If the adverse reaction improves within 4 weeks, resume the medication at the next scheduled dose. If the adverse reaction does not resolve within 4 weeks, permanently discontinue Larotrectinib.

[Contraindications]

Larotrectinib is contraindicated in patients with a known hypersensitivity to Larotrectinib or to any of the excipients contained in this product. 【Adverse Reactions】

The most common side effects of Larotrectinib include: fatigue, nausea, cough, constipation, diarrhea, dizziness, vomiting, and elevated blood levels of the liver enzymes AST and ALT.

Most patients (93%) experienced Grade 1 or Grade 2 adverse events (AEs). No treatment-related Grade 4 AEs occurred; the most common treatment-related Grade 3 AEs included: increased ALT or AST levels (5%), anemia (2%), decreased neutrophil count (2%), nausea (2%), and dizziness (2%).

【Warnings and Precautions】

1. Neurological Problems: If you experience any adverse reactions—such as difficulty speaking, dizziness, coordination problems, tingling, numbness, or a burning sensation in your hands or feet—please inform your healthcare provider. Your doctor may temporarily suspend treatment, reduce the dosage, or permanently discontinue Larotrectinib.

2. Liver Problems: Your healthcare provider will conduct blood tests to monitor your liver function during treatment. If you develop signs of liver problems—including loss of appetite, nausea or vomiting, or pain in the upper right side of your stomach—treatment may be temporarily suspended, the dosage reduced, or the medication permanently discontinued.

3. Pregnancy or Planning to Conceive: Larotrectinib may harm an unborn baby; therefore, you should not become pregnant during treatment. Women of childbearing potential should use effective contraception (birth control) during treatment and for at least one week after the final dose. Discuss appropriate methods of contraception with your doctor.

4. Breastfeeding: It is currently unknown whether Larotrectinib passes into breast milk. Do not breastfeed during treatment or for one week after your final dose.

5. Inform your healthcare provider about all medications you are taking, including prescription and over-the-counter drugs, vitamins, and herbal supplements. Certain other medications may affect how Larotrectinib works.

【Safety and Efficacy】

According to data published by the FDA: 73% of patients experienced a duration of response of 6 months or longer; 63% of patients experienced a duration of response of 9 months or longer; and 39% of patients experienced a duration of response of 12 months or longer. In February 2018, the *New England Journal of Medicine (NEJM)*—one of the world's four leading authoritative medical journals—published results from three clinical studies assessing the safety and efficacy of the anti-cancer drug Larotrectinib. These results demonstrated an overall response rate of 75% in patients ranging in age from 4 months to 76 years, across the treatment of 17 different types of cancer. These findings were subsequently validated by the FDA.

Shortly thereafter, at the European Society for Medical Oncology (ESMO) conference held in October 2018, clinical data regarding the use of Larotrectinib to treat adult and pediatric patients with TRK fusion cancers—encompassing 24 distinct tumor types—revealed the following: Overall Response Rate: 80%; Partial Response Rate: 62%; and Complete Response Rate: 18%.

【Storage】

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted within the range of 15°C to 30°C (59°F to 86°F) for short-term transport.