Rozlytrek

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Entrectinib 200mg;  

Available from:

Roche Products (NZ) Ltd

Dosage:

200 mg

Pharmaceutical form:

Capsule

Composition:

Active: Entrectinib 200mg   Excipient: Colloidal silicon dioxide Crospovidone Hypromellose     Lactose Magnesium stearate Microcrystalline cellulose Sunset yellow aluminium lake   Tartaric acid TekPrint blue SB-6018 Titanium dioxide  

Prescription type:

Prescription

Therapeutic indications:

Solid tumours Rozlytrek is indicated for the treatment of adult and paediatric patients 12 years of age and older, with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive locally advanced or metastatic solid tumours, who have progressed following prior therapies, or as initial therapy when there are no acceptable standard therapies. This indication was approved based on objective response rate and response duration in single-arm trials. Continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials. Non-small cell lung cancer (NSCLC) Rozlytrek is indicated for the treatment of adult patients with ROS1-positive, locally advanced or metastatic NSCLC.

Product summary:

Package - Contents - Shelf Life: Bottle, HDPE with PP/PE CRC screw cap with integrated desiccant - 90 capsules - 48 months from date of manufacture stored at or below 30°C

Authorization date:

2019-05-31

Patient Information leaflet

rocrozly10623
1

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 ca

Summary of Product characteristics

Rozlytrek 20230613
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Rozlytrek (entrectinib) 100 mg and 200 mg hard capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 mg hard capsule contains 100 mg entrectinib.
Each 200 mg hard capsule contains 200 mg entrectinib.
Excipients with known effect
Each 100 mg hard capsule contains 65 mg lactose. Each 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 hard capsules are yellow with “ENT 100” imprinted
in blue on the body.
Rozlytrek 200 mg hard capsules are orange with “ENT 200” imprinted
in blue on the body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SOLID TUMOURS
Rozlytrek is indicated for the treatment of adult and paediatric
patients 12 years of age and
older, with neurotrophic tyrosine receptor kinase (NTRK)
fusion-positive locally advanced or
metastatic solid tumours, who have progressed following prior
therapies, or as initial therapy
when there are no acceptable standard therapies.
This indication was approved based on objective response rate and
response duration in single-
arm trials. Continued approval for this indication depends on
verification and description of
clinical benefit in the confirmatory trials.
NON-SMALL CELL LUNG CANCER (NSCLC)
Rozlytrek is indicated for the treatment of adult patients with
ROS1-positive, locally advanced
or metastatic NSCLC.
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL
Patient selection
_Solid tumours _
A validated assay is required for the selection of patients with NTRK
fusion-positive locally
advanced or metastatic solid tumours. NTRK fusion-positive status
should be established prior
to initiation of Rozlytrek therapy.
Rozlytrek 20230613
2
_NSCLC _
A validated assay is required for the selection of patients with
ROS1-positive locally advanced
or metastatic NSCLC. ROS1-positive status should be established prior
to initiation of
Rozlytrek therapy.
DOSE
Adult patients
The recommended do