ENTRECTINIB 100 / 200 MG CAPSULES
ROZLYTREK (entrectinib) is a kinase inhibitor. ROZLYTREK (entrectinib) capsules for oral use are supplied as printed hard-shell capsules containing 100 mg (yellow opaque HPMC capsule) or 200 mg of entrectinib (orange opaque HPMC capsule). Inactive ingredients are tartaric acid, lactose anhydrous, hypromellose, crospovidone, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate.
ROZLYTREK (entrectinib) Capsules: 100 mg and 200 mg
Recommended Dosage for ROS1-Positive Non-Small Cell Lung Cancer: 600 mg orally once daily. • Recommended Dosage for NTRK Gene Fusion-Positive Solid Tumors: o Adults: 600 mg orally once daily.
ROZLYTREK (entrectinib) is a kinase inhibitor indicated for the treatment of: • Adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. • Adult and pediatric patients 12 years of age and older with solid tumors that: o have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, o are metastatic or where surgical resection is likely to result in severe morbidity, and o have progressed following treatment or have no satisfactory alternative therapy.
