ROZLYTREK HARD CAPSULE 200MG

Држава: Сингапур

Језик: Енглески

Извор: HSA (Health Sciences Authority)

Активни састојак:

Entrectinib (Form A) or (Form C)

Доступно од:

ROCHE SINGAPORE PTE. LTD.

АТЦ код:

L01XE56

Фармацеутски облик:

CAPSULE

Састав:

Entrectinib (Form A) or (Form C) 200.00mg

Пут администрације:

ORAL

Тип рецептора:

Prescription Only

Произведен од:

Mayne Pharma Inc.

Статус ауторизације:

ACTIVE

Датум одобрења:

2021-01-27

Карактеристике производа

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