GAVRETO

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PRALSETINIB

Available from:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

ATC code:

L01EX23

Pharmaceutical form:

HARD CAPSULE

Composition:

PRALSETINIB 100 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

HOFFMANN LA ROCHE LTD, SWITZERLAND

Therapeutic area:

PRALSETINIB

Therapeutic indications:

- GAVRETO is indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC).- GAVRETO is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy.- GAVRETO is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

Authorization date:

2022-03-20

Patient Information leaflet

Gavreto PL version 2
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
GAVRETO
100 MG
Hard capsules
COMPOSITION:
Each capsule contains:
pralsetinib 100 mg
* For information on inactive ingredients and allergens, see section 6
‘Additional
information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This
leaflet contains concise information about this medicine. If you have
any further
questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others.
It may harm them, even if it seems to you that their illness is
similar to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Gavreto is intended for the treatment of certain cancers caused by an
abnormal
gene called RET (rearranged during transfection):
In adult patients with metastatic RET fusion-positive non-small cell
lung cancer
(NSCLC).
In patients 12 years of age and older with advanced or metastatic RET
mutant
medullary thyroid cancer (MTC), who require systemic therapy.
In patients 12 years of age and older with advanced or metastatic RET
fusion-
positive thyroid cancer, who require systemic therapy and who are
radioactive
iodine refractory.
THERAPEUTIC GROUP
Tyrosine kinase inhibitors.
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 lead to
uncontrolled
cell growth and cancer. Gavreto blocks the action of abnormal RET
proteins and
may help to stop or slow lung or thyroid cancer from growing. It may
also help to
shrink the cancer.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
You are sensitive (allergic) to the active ingredient (pralsetinib) or
to any of the
other ingredients in this medicine (see section 6 – ‘Additional
information’).
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
BEFORE TREATMENT WITH GAVRETO, TELL YOUR DOCTOR IF YOU:
have lung or b

Summary of Product characteristics

Gavreto PI ver 3
Gavreto
®
Pralsetinib
Hard capsules
NAME OF THE MEDICINAL PRODUCT
GAVRETO
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 100 mg of pralsetinib.
For the full list of excipients, see section 11.
PHARMACEUTICAL FORM
Hard capsules.
1
INDICATIONS AND USAGE
1.1
Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
GAVRETO is indicated for the treatment of adult patients with
metastatic RET fusion-positive
non-small cell lung cancer (NSCLC).
1.2
RET-Mutant Medullary Thyroid Cancer
GAVRETO is indicated for the treatment of adult and pediatric patients
12 years of age and older
with advanced or metastatic RET-mutant medullary thyroid cancer (MTC)
who require systemic
therapy.
1.3
RET Fusion-Positive Thyroid Cancer
GAVRETO is indicated for the treatment of adult and pediatric patients
12 years of age and older
with advanced or metastatic RET fusion-positive thyroid cancer who
require systemic therapy
and who are radioactive iodine-refractory (if radioactive iodine is
appropriate).
Gavreto PI ver 3
2
DOSAGE AND ADMINISTRATION
2.1
Patient Selection
Select patients for treatment with GAVRETO based on the presence of a
RET gene fusion
(NSCLC or thyroid cancer) or RET gene mutation (MTC) [see Clinical
Studies (14)].
2.2
Recommended Dosage
The recommended dosage of GAVRETO is 400 mg orally once daily on an
empty stomach (the
capsules should be swallowed whole with a glass of water, no food
intake for at least 2 hours
before and at least 1 hour after taking GAVRETO) [see Clinical
Pharmacology (12.3)].
Continue treatment until disease progression or until unacceptable
toxicity.
If a dose of GAVRETO is missed, it can be taken as soon as possible on
the same day. Resume
the regular daily dose schedule for GAVRETO the next day.
Do not take an additional dose if vomiting occurs after GAVRETO but
continue with the next
dose as scheduled.
2.3
Dosage Modifications for Adverse Reactions
The recommended dose reductions and dosage modifications for adverse
reactions are provided
in Table 1 and Tabl