Larotrectinib Larotrectinib is a broad-spectrum anticancer drug that is effective against many different tumors.

LuciLaro capsules simple instructions

Please use under the guidance of a physician

Product Name: LuciLaro

Manufacturer: Lucius Pharmaceuticals (Laos) Co., Ltd.

Chinese name: Larotrectinib Capsules

English name: Larotrectinib capsules

Drug approval number: 05 L 0977/23

 

【Indications】

LuciLaro is a kinase inhibitor indicated for the treatment of adult and pediatric patients with the following solid tumors:

• Have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion and no known acquired resistance mutation;

• Metastatic or surgical resection may result in significant morbidity;

• There are no satisfactory alternative treatments or the disease has progressed despite treatment.

 

【Usage and Dosage】

• Select patients for treatment with LuciLaro based on the presence or absence of NTRK gene fusion.

• Recommended dose for adults and pediatric patients with a body surface area of ​​at least 1.0 m2: 100 mg twice daily.

• Recommended dose for pediatric patients with a body surface area less than 1.0 m2: 100 mg/m2 twice daily.

 

【Specification】

100mg/capsule, 30 capsules/box.

 

【 Contraindications 】

none.

 

【Warnings and precautions】

• Neurotoxicity: Inform patients and caregivers of the risk of adverse neurological reactions. If neurotoxicity occurs, advise patients not to drive or operate hazardous machinery. Depending on severity, withhold and adjust dose, or permanently discontinue LuciLaro.

• Hepatotoxicity: Monitor liver function tests, including ALT and AST, every 2 weeks during the first month of treatment, monthly thereafter, and as clinically indicated. Based on severity, withhold and adjust dose, or permanently discontinue LuciLaro.

• Embryo-Fetal Toxicity: May cause harm to the fetus. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.

 

【Adverse Reactions】

The most common adverse reactions (≥ 20%) with LuciLaro were fatigue, nausea, dizziness, vomiting, increased AST, cough, increased ALT, constipation, and diarrhea.

 

【Drug Interactions】

• Strong CYP3A4 Inhibitors: Avoid coadministration of strong CYP3A4 inhibitors with LuciLaro. If coadministration cannot be avoided, reduce the LuciLaro dose.

• Strong CYP3A4 Inducers: Avoid coadministration of strong CYP3A4 inducers with LuciLaro. If coadministration cannot be avoided, increase the LuciLaro dose.

• Sensitive CYP3A4 Substrates: Avoid coadministration of sensitive CYP3A4 substrates with LuciLaro.

 

【Use by specific groups】

• Lactation: Breastfeeding is not recommended.

• Hepatic Impairment: Reduce the starting dose of LuciLaro in patients with moderate (Child-Pugh B) to severe (Child-Pugh C) hepatic impairment.

 

【Storage】

Storage temperature is 20℃ to 25℃ (68℉ to 77℉), short-distance transportation is allowed between 15℃ to 30℃ (59℉ to 86℉). Protect from moisture.