ROZLYTREK HARD CAPSULE 100MG

Država: Singapur

Jezik: engleski

Izvor: HSA (Health Sciences Authority)

Aktivni sastojci:

Entrectinib (Form A) or (Form C)

Dostupno od:

ROCHE SINGAPORE PTE. LTD.

ATC koda:

L01XE56

Farmaceutski oblik:

CAPSULE

Sastav:

Entrectinib (Form A) or (Form C) 100.000mg

Administracija rute:

ORAL

Tip recepta:

Prescription Only

Proizveden od:

Mayne Pharma Inc.

Status autorizacije:

ACTIVE

Datum autorizacije:

2021-01-27

Svojstava lijeka

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