ROZLYTREK entrectinib 100 mg hard capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

entrectinib, Quantity: 100 mg

Available from:

Roche Products Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: magnesium stearate; tartaric acid; strong ammonia solution; crospovidone; Shellac; iron oxide yellow; lactose; colloidal anhydrous silica; titanium dioxide; hypromellose; propylene glycol; microcrystalline cellulose; indigo carmine aluminium lake

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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 was approved via the provisional approval pathway, based on objective response rate and duration of response in single-arm trials. Full registration for this indication depends on verification and description of clinical benefit in confirmatory trials.

Product summary:

Visual Identification: Size 2 hard capsules with yellow body and cap with 'ENT 100' imprinted in blue on the body; Container Type: Bottle; Container Material: HDPE; Container Life Time: 48 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered (with Provisional Indication/s)

Authorization date:

2020-05-15

Patient Information leaflet

This medicine is subject to additional monitoring. This will allow
quick identification of new safety information. You can
help by reporting any side effects you may get. You can report side
effects to your doctor, or directly at www.tga.gov.au/
reporting-problems .
ROZLYTREK
®
_entrectinib_
CONSUMER MEDICINE INFORMATION
THIS MEDICINE HAS PROVISIONAL APPROVAL IN AUSTRALIA FOR NTRK
FUSION-POSITIVE CANCER. THE DECISION TO APPROVE THIS
MEDICINE HAS BEEN MADE ON THE BASIS OF PROMISING RESULTS FROM
PRELIMINARY STUDIES. MORE EVIDENCE IS REQUIRED TO BE
SUBMITTED WHEN AVAILABLE TO FULLY CONFIRM THE BENEFIT AND SAFETY OF
THE MEDICINE FOR THIS USE.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Rozlytrek. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Rozlytrek
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
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.
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 wor

Summary of Product characteristics

Rozlytrek 20220325
1
This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report
any suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION
ROZLYTREK
TM (ENTRECTINIB)
1.
NAME OF THE MEDICINE
entrectinib
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 mg hard capsule contains 100 mg entrectinib.
Each 200 mg hard capsule contains 200 mg entrectinib.
Entrectinib has the molecular formula C
31
H
34
F
2
N
6
O
2
. The molecular weight is 560.6. The
chemical name is
N-{5-[(3,5-difluorophenyl)methyl]-1H-indazol-3-yl}-4-(4-methylpiperazin-
1-yl)-2-[(oxan-4-yl)amino]benzamide. The solubility in aqueous media
decreases over the
range pH 1.2 to pH 8.0.
Excipients with known effect
Each 100 mg hard capsule contains 65 mg lactose. E ach 200 mg hard
capsule contains 130 mg
lactose. For the full list of excipients, see section 6.1
_List of excipients_
.
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 INDICATIONS
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.
▼

Rozlytrek 20220325
2
This indication was approved via the
PROVISIONAL APPROVAL
pathway,