Gavreto

País: Unió Europea

Idioma: anglès

Font: EMA (European Medicines Agency)

ingredients actius:

pralsetinib

Disponible des:

Roche Registration GmbH 

Codi ATC:

L01XE

Designació comuna internacional (DCI):

pralsetinib

Grupo terapéutico:

Antineoplastic agents

Área terapéutica:

Carcinoma, Non-Small-Cell Lung

indicaciones terapéuticas:

Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.

Resumen del producto:

Revision: 6

Estat d'Autorització:

Authorised

Data d'autorització:

2021-11-18

Informació per a l'usuari

28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GAVRETO 100 MG HARD CAPSULES
pralsetinib
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 or pharmacist.
•
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Gavreto is and what it is used for
2.
What you need to know before you take Gavreto
3.
How to take Gavreto
4.
Possible side effects
5.
How to store Gavreto
6.
Contents of the pack and other information
1.
WHAT GAVRETO IS AND WHAT IT IS USED FOR
WHAT GAVRETO IS
Gavreto is a cancer medicine that contains the active substance
pralsetinib.
WHAT GAVRETO IS USED FOR
Gavreto is used to treat adults with advanced stages of a form of lung
cancer called ‘non-small cell
lung cancer’ (‘NSCLC’), that presents with a specific
rearrangement in a gene called rearranged
during transfection (RET) if you have not been previously treated with
another RET inhibitor
medicine.
HOW GAVRETO WORKS
In patients whose cancer is due to an altered RET gene, the change in
the gene causes the body to
make an abnormal protein called a RET fusion protein, which can lead
to uncontrolled cell growth and
cancer. Gavreto blocks the action of RET fusion proteins and may help
to slow or stop your lung
cancer from growing. It may also help to shrink your cancer.
If you have any questions about how Gavreto works or why this medicine
has been

Fitxa tècnica

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
GAVRETO 100 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 100 mg of pralsetinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Light blue, opaque hard capsule, size 0 (22 mm long x 7 mm wide) with
“BLU-667” printed on the
capsule shell body and “100 mg” on the capsule shell cap in white
ink.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gavreto is indicated as monotherapy for the treatment of adult
patients with rearranged during
transfection (RET) fusion-positive advanced non-small cell lung cancer
(NSCLC) not previously
treated with a RET inhibitor.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
administration of anticancer medicinal
products.
Patient selection for treatment of RET fusion-positive advanced NSCLC
should be based on a
validated test method.
Posology
The recommended dose is 400 mg pralsetinib once daily on an empty
stomach (see method of
administration). Treatment should be continued until disease
progression or unacceptable toxicity.
If vomiting occurs after taking a dose of pralsetinib, the patient
should not take an additional dose but
continue with the next scheduled dose.
_Missed doses _
_ _
If a dose of pralsetinib is missed, the patient should make up for the
missed dose as soon as possible
on the same day. The regular daily dose schedule for pralsetinib
should be resumed the next day.
3
_Dose modifications for adverse reactions _
_ _
Interruption of treatment with or without dose reduction may be
considered to manage adverse
reactions based on severity and clinical presentation.
Patients may have their dos