Rozlytrek (Entrectinib) 200mg Hard Capsules

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Entrectinib

Available from:

ROCHE (MALAYSIA) SDN. BHD.

INN (International Name):

Entrectinib

Units in package:

90 Capsules

Manufactured by:

Mayne Pharma Inc.

Patient Information leaflet

_ _
_Consumer Medication Information Leaflet (RiMUP) _
ROZLYTREK ®
HARD CAPSULES
Entrectinib (100mg, 200mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Rozlytrek is used for
2.
How Rozlytrek works
3.
Before you use Rozlytrek
4.
How to use Rozlytrek
5.
While you are using Rozlytrek
6.
Side effects
7.
Storage and disposal of
Rozlytrek
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of Revision
12.
Serial Number
WHAT ROZLYTREK IS USED FOR
Rozlytrek is used to treat adults with
a type of lung cancer called non-
small cell lung cancer. It is used if
your cancer:

is 'ROS1-positive' – this means
your cancer cells have an
alteration in a gene called ROS1
and

is advanced or has spread to
another part of your body
(metastatic)
Rozlytrek is also used to treat
children (12 years and older),
adolescents and adults with cancer
that is ‘NTRK fusion-positive’. This
means that your cancer cells have an
alteration in one of the NTRK genes.
Rozlytrek is used when the cancer is
advanced or has spread to another
part of your body (metastatic) and
other treatments have not worked or
are not suitable for you.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
HOW ROZLYTREK WORKS
Rozlytrek contains the active
ingredient entrectinib.
Rozlytrek belongs to a group of
medicines called anti-neoplastic (or
anti-cancer) agents which are used to
treat cancer.
Rozlytrek works by blocking the
action of enzymes which have an
alteration in them. This is due to the
alteration in the NTRK or ROS1
genes that make them. The altered
enzymes encourage the cancer cells
to grow.
Rozlytrek may slow down or stop the
cancer growing. It may also help to
shrink your cancer.
BEFORE YOU USE ROZLYTREK
-
_WHEN YOU MUST NOT USE IT _
Do not take Rozlytrek if you have an
allergy to:

any medicine containing
entrectinib

any of the ingredients listed at the
end of

Summary of Product characteristics

PACK INSERT FOR MALAYSIA
ROZLYTREK
®
100mg and 200mg Hard Capsules
Entrectinib
1.
NAME OF THE MEDICINE
entrectinib
2.
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 fill mass_: Lactose anhydrous, Microcrystalline cellulose,
Tartaric acid, Hypromellose, Crospovidone,
Magnesium stearate, Colloidal silicon dioxide
_Capsule shell 100 mg_: Hypromellose, Titanium dioxide (E171,
CI77891), Yellow iron oxide (E172, CI77492),
Printing Ink (shellac, propylene glycol, strong ammonia solution, and
FD & C Blue #2 Aluminum Lake)
_Capsule shell_ 200 mg: Hypromellose, Titanium dioxide (E171,
CI77891), FD&C Yellow #6 (E110, CI15985),
Printing Ink (shellac, propylene glycol, strong ammonia solution, and
FD & C Blue #2 Aluminum Lake)
3.
PHARMACEUTICAL FORM
Hard capsule.
Rozlytrek 100 mg are size 2 hard capsules with yellow body and cap
with “ENT 100” imprinted in blue on
the body.
Rozlytrek 200 mg are size 0 hard capsules with orange body and cap
with “ENT 200” imprinted in blue on
the body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION(S)
NON-SMALL CELL LUNG CANCER (NSCLC)
Rozlytrek is indicated for the treatment of adult patients with
advanced non-small cell lung cancer (NSCLC)
whose tumours are ROS1-positive.
SOLID TUMOURS
Rozlytrek is indicated for the treatment of adult and paediatric
patients 12 years of age and older with solid
tumours that:

have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion
without a known acquired
resistance mutation,

are metastatic or where surgical resection is likely to result in
severe morbidity, and

have either progressed following treatment or have no satisfactory
alternative therapy.
This indication is approved under conditional registration which is
based on overall response rate and duration
of response (see section 5.1 _ Pharmacodynamic properties; Clinical
trials_). Continued approval for this
indicatio