Rozlytrek

País: União Europeia

Língua: inglês

Origem: EMA (European Medicines Agency)

Ingredientes ativos:

Entrectinib

Disponível em:

Roche Registration GmbH 

Código ATC:

L01EX14

DCI (Denominação Comum Internacional):

entrectinib

Grupo terapêutico:

Antineoplastic agents

Área terapêutica:

Cancer; Carcinoma, Non-Small-Cell Lung

Indicações terapêuticas:

Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior NTRK inhibitorwho have no satisfactory treatment options.Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1 positive, advanced non small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.

Resumo do produto:

Revision: 7

Status de autorização:

Authorised

Data de autorização:

2020-07-31

Folheto informativo - Bula

39
B. PACKAGE LEAFLET
40
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROZLYTREK 100
MG HARD CAPSULES
ROZLYTREK 200
MG HARD CAPSULES
entrectinib
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. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Rozlytrek is and what it is used for
2.
What you need to know before you take Rozlytrek
3.
How to take Rozlytrek
4.
Possible side effects
5.
How to store Rozlytrek
6.
Contents of the pack and other information
1.
WHAT ROZLYTREK IS AND WHAT IT IS USED FOR
WHAT ROZLYTREK IS
Rozlytrek is a cancer medicine that contains the active substance
entrectinib.
WHAT ROZLYTREK IS USED FOR
Rozlytrek is used to treat either:
•
adults and children 12 years of age and older with solid tumour
(cancer) in various parts of the
body that is caused by a change in the neurotrophic tyrosine receptor
kinase (
_NTRK_
) gene, or
•
adults with a type of lung cancer called ‘non-small cell lung
cancer’ (NSCLC) that is caused by
a change in the
_ROS1_
gene.
_NTRK_
gene fusion-positive solid tumour cancer
It is used when:
•
a test has shown that your cancer cells have a change in genes called
‘
_NTRK_
’ and has spread
within the affected organ or to other organs in your body or if
surgery to remove the cancer is
likely to result in severe complications (see ‘How Rozlytrek
works

Características técnicas

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Rozlytrek 100 mg hard capsules
Rozlytrek 200 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rozlytrek 100 mg hard capsules
Each hard capsule contains 100 mg of entrectinib.
_Excipients with known effect _
Each hard capsule contains 65 mg lactose.
Rozlytrek 200 mg hard capsules
Each hard capsule contains 200 mg of entrectinib.
_Excipients with known effect _
Each hard capsule contains 130 mg lactose, and 0.6 mg of the azo
colouring agent sunset yellow FCF
(E110).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Rozlytrek 100 mg hard capsules
Size 2 (18 mm in length), hard capsule with yellow opaque body and cap
with ENT 100 imprinted in
blue on the body.
Rozlytrek 200 mg hard capsules
Size 0 (21.7 mm in length), hard capsule with orange opaque body and
cap with ENT 200 imprinted in
blue on the body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rozlytrek as monotherapy is indicated for the treatment of adult and
paediatric patients 12 years of age
and older with solid tumours expressing a neurotrophic tyrosine
receptor kinase (
_NTRK_
) gene fusion,
•
who have a disease that is locally advanced, metastatic or where
surgical resection is likely to
result in severe morbidity, and
•
who have not received a prior
_NTRK_
inhibitor
•
who have no satisfactory treatment options (see sections 4.4 and 5.1).
3
Rozlytrek as monotherapy is indicated for the treatment of adult
patients with
_ROS1_
-positive,
advanced non-small cell lung cancer (NSCLC) not previously treated
with ROS1 inhibitors.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Rozlytrek should be initiated by a physician
experienced in the use of anticancer
medi