Valsts: Singapūra
Valoda: angļu
Klimata pārmaiņas: HSA (Health Sciences Authority)
Entrectinib (Form A) or (Form C)
ROCHE SINGAPORE PTE. LTD.
L01XE56
CAPSULE
Entrectinib (Form A) or (Form C) 200.00mg
ORAL
Prescription Only
Mayne Pharma Inc.
ACTIVE
2021-01-27
Please visit www.roche.com.sg/pharma/rozlytrek for a printable version of this leaflet. CAP-ROZ-2023 07 Rozlytrek ® Entrectinib 1. DESCRIPTION 1.1 THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG Antineoplastic agent, Tyrosine Kinase inhibitor ATC Code: L01EX14 1.2 TYPE OF DOSAGE FORM Hard Capsule Rozlytrek 100 mg are size 2 hard capsules with yellow opaque body and cap with “ENT 100” imprinted in blue on the body. Rozlytrek 200 mg are size 0 hard capsules with orange opaque body and cap with “ENT 200” imprinted in blue on the body. 1.3 ROUTE OF ADMINISTRATION Oral 1.4 STERILE / RADIOACTIVE STATEMENT Not applicable 1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: entrectinib Each 100 mg hard capsule contains 100 mg entrectinib. Each 200 mg hard capsule contains 200 mg entrectinib. Excipients Capsule content: tartaric acid, lactose, hypromellose, crospovidone, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate. Capsule shell: hypromellose, titanium dioxide (E171), yellow iron oxide (E172, for yellow opaque capsule shell – 100 mg hard capsule), FD&C yellow #6 (E110, for orange opaque capsule shell – 200 mg hard capsule). Printing ink: shellac, propylene glycol, strong ammonia solution, FD&C blue #2 aluminium lake (E132). 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION(S) Solid tumors Rozlytrek is indicated for the treatment of adult and pediatric patients 12 years of age and older, with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumors without a known acquired resistance mutation, that are locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have progressed following prior therapies or have no satisfactory alternative treatments. Non-small cell lung cancer (NSCLC) Rozlytrek is indicated for the treatment of adult patients with ROS1- positive, locally advanced or metastatic NSCLC. 2.2 DOSAGE AND ADMINISTRATION General Patient Selection Solid Tumors A validated assay is required for the selectio Izlasiet visu dokumentu