HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciLaro safely and effectively. See full prescribing information for LuciLaro.

INDICATIONS AND USAGE

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

• have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,

• are metastatic or where surgical resection is likely to result in severe morbidity, and

• have no satisfactory alternative treatments or that have progressed following treatment.

DOSAGE AND ADMINISTRATION

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

• Recommended Dosage in Adult and Pediatric Patients with Body Surface Area of at Least 1.0 Meter-Squared: 100 mg orally twice daily.

• Recommended Dosage in Pediatric Patients with Body Surface Area of Less Than 1.0 Meter-Squared: 100 mg/m2 orally twice daily.

DOSAGE FORMS AND STRENGTHS

Capsules: 100mg×30 capsules

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

• Neurotoxicity: Advise patients and caretakers of the risk of neurologic adverse reactions. Advise patients not to drive or operate hazardousmachinery if experiencing neurotoxicity. Withhold and modify dosage, or permanently discontinue LuciLaro based on severity.

• Hepatotoxicity: Monitor liver tests including ALT and AST every 2 weeksduring the first month of treatment, then monthly thereafter and as clinically indicated. Withhold and modify dosage, or permanently discontinue LuciLaro based on severity.

• Embryo-Fetal Toxicity: Can cause fetal harm. Advise females with reproductive potential of 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 CYP3A4inhibitors with LuciLaro. If coadministration cannot be avoided, reduce the LuciLaro dose.

• Strong CYP3A4 Inducers: Avoid coadministration of strong CYP3A4inducers with LuciLaro. If coadministration cannot be avoided, increase the LuciLaro dose.

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

USE IN SPECIFIC POPULATIONS

• Lactation: Advise not to breastfeed.

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

Storage

Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.