Description
Entrectinib
Each LuciEntre capsule contains: Entrectinib…………………………..100mg.
INDICATION
LuciEntre is a kinase inhibitor indicated for the treatment of: • Adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. • Adult and pediatric patients 12 years of age and older with solid tumors that: • Have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion as detected by an FDAapproved test without a known acquired resistance mutation, • Are metastatic or where surgical resection is likely to result in severe morbidity, and *Have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate an d durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
DOSAGE AND USE
• Recommended Dosage for ROS1-Positive Non-Small Cell Lung Cancer: 600 mg orally once daily. • Recommended Dosage for NTRK Gene Fusion-Positive
Solid Tumors: •Adults: 600mgorallyoncedaily. * Pediatric Patients 12 Years and Older: Recommended dosage is based on body surface area (BSA) as shown below * BSA greater than 1.50 m2: 600 mg once daily. * BSA 1.11 to 1.50 m2: 500 mg once daily.
* BSA 0.91 to 1.10 m2: 400 mg once daily. Capsule should be swallowed whole & not chewed or crushed. If you miss a dose of LuciEntre, take it as soon as you remember. If your next dose is due within12 hours, skip the missed dose and take your next dose at your regular time.
STORAGE
In a dry place and store at 20°C to 25°C.
WARNINGS
Keep medicine out of reach of Children. Do not administer LuciEntre during Pregnancy and Lactation.
Entrectinib
Each LuciEntre capsule contains: Entrectinib…………………………..200mg.
INDICATION
LuciEntre is a kinase inhibitor indicated for the treatment of: • Adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. • Adult and pediatric patients 12 years of age and older with solid tumors that: • Have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion as detected by an FDAapproved test without a known acquired resistance mutation, • Are metastatic or where surgical resection is likely to result in severe morbidity, and *Have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate an d durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
DOSAGE AND USE
• Recommended Dosage for ROS1-Positive Non-Small Cell Lung Cancer: 600 mg orally once daily. • Recommended Dosage for NTRK Gene Fusion-Positive
Solid Tumors:
•Adults: 600mgorallyoncedaily. * Pediatric Patients 12 Years and Older: Recommended dosage is based on body surface area (BSA) as shown below * BSA greater than 1.50 m2: 600 mg once daily. * BSA 1.11 to 1.50 m2: 500 mg once daily. * BSA 0.91 to 1.10 m2: 400 mg once daily. Capsule should be swallowed whole & not chewed or crushed. If you miss a dose of LuciEntre, take it as soon as you remember. If your next dose is due within12 hours, skip the missed dose and take your next dose at your regular time.
STORAGE
In a dry place and store at 20°C to 25°C.
WARNINGS
Keep medicine out of reach of Children. Do not administer LuciEntre during Pregnancy and Lactation.
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