GAVRETO CAPSULES

Country: Afrika t’Isfel

Lingwa: Ingliż

Sors: South African Health Products Regulatory Authority (SAHPRA)

Disponibbli minn:

Roche Products (Pty) Ltd

Dożaġġ:

100,0 mg

Għamla farmaċewtika:

CAPSULES

Kompożizzjoni:

EACH CAPSULE CONTAINS PRASETINIB 100,0 mg

L-istatus ta 'awtorizzazzjoni:

Registered

Fuljett ta 'informazzjoni

GAVRETO
®
(560684; Regd)
pralsetinib – 100 mg hard capsules
eCTD sequence 0005
1
1.3.2 Approved PIL
_ SAHPGL-CEM-03_v_
7
_ _
_17 Oct 2023; CDS 2.0 Page 1 of 10 _
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S4
GAVRETO
®
100 mg hard capsules
Sugar free
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING GAVRETO

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor, pharmacist,
nurse or healthcare provider.

Gavreto has been prescribed for you personally and you should not
share your medicine with other
people. It may harm them, even if their symptoms are the same as
yours.
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 a prescription medicine that is used to treat certain
cancers caused by an abnormal gene
called rearranged during transfection (RET):

adults with advanced stages of a form of a lung cancer called
‘non-small cell lung cancer’ (‘NSCLC’)
GAVRETO
®
(560684; Regd)
pralsetinib – 100 mg hard capsules
eCTD sequence 0005
1
1.3.2 Approved PIL
_ SAHPGL-CEM-03_v_
7
_ _
_17 Oct 2023; CDS 2.0 Page 2 of 10 _

adults with advanced medullary thyroid cancer (MTC) or MTC that has
spread who require a
medicine by mouth or injection (systemic therapy).

adults with thyroid cancer who require a medicine by mouth or
injection (systemic therapy) and who
have received radioactive iodine and it did not work or is no longer
working.
GAVRETO is used when a test has shown that your cancer cells have a
change in the _RET_ gene.
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 RET protein, which can le

Karatteristiċi tal-prodott

GAVRETO
®
(560684; Regd)
pralsetinib – 100 mg hard capsules
eCTD sequence 0005
1
1.3.1.1 Approved PI
_ _
_ SAHPGL-CEM-02_v5 _
_ 17 Oct 2023; CDS 2.0 Page 1 of 28_
PROFESSIONAL INFORMATION
SCHEDULING STATUS
S4
1 NAME OF THE MEDICINE
GAVRETO
®
100 mg hard capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 100 mg pralsetinib.
Sugar free
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Hard capsule.
Size 0, light blue opaque capsule shell with white imprint
“BLU-667” on the body and white imprint “100
mg” on the cap, containing a white to off-white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_NON-SMALL CELL LUNG CANCER (NSCLC) _
Gavreto is indicated for the treatment of adult patients with
rearranged during transfection (_RET_) fusion-
positive, locally advanced or metastatic NSCLC.
_RET-MUTANT MEDULLARY THYROID CANCER (MTC) _
Gavreto is indicated for the treatment of adult patients with locally
advanced or metastatic _RET_-mutant
MTC who require systemic therapy.
GAVRETO
®
(560684; Regd)
pralsetinib – 100 mg hard capsules
eCTD sequence 0005
1
1.3.1.1 Approved PI
_ _
_ SAHPGL-CEM-02_v5 _
_ 17 Oct 2023; CDS 2.0 Page 2 of 28_
_RET-FUSION POSITIVE THYROID CANCER _
Gavreto is indicated for the treatment of adult patients with locally
advanced or metastatic _RET_-fusion
positive thyroid cancer who require systemic therapy and who are
radioactive iodine-refractory (if
radioactive iodine is appropriate).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
GENERAL
A validated assay is required for the selection of patients with a
_RET_-gene fusion (NSCLC or thyroid
cancer) or a _RET_-gene mutation (MTC).
POSOLOGY
_ADULTS _
The recommended dose of Gavreto for adults is 400 mg given orally,
once daily.
DURATION OF TREATMENT
It is recommended that patients are treated with Gavreto until disease
progression or unmanageable
toxicity.
DELAYED OR MISSED DOSES
If a planned dose of Gavreto is missed, patients can make up that dose
unless the next dose is due
withi