GAVRETO HARD CAPSULES 100mg

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

Pralsetinib

Saatavilla:

ROCHE SINGAPORE PTE. LTD.

ATC-koodi:

L01EX23

Lääkemuoto:

CAPSULE

Koostumus:

Pralsetinib 100.0mg

Antoreitti:

ORAL

Prescription tyyppi:

Prescription Only

Valmistaja:

Catalent CTS, LLC

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

2023-04-06

Valmisteyhteenveto

1
Please visit www.roche.com.sg/pharma/gavreto for a printable version
of this
leaflet.
CAP-GAV-2023 09
GAVRETO
™
Pralsetinib
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Pharmacotherapeutic group: Antineoplastic agent, protein kinase
inhibitors
ATC code: L01EX23
1.2
TYPE OF DOSAGE FORM
Hard Capsule
Gavreto 100mg are size 0 light blue opaque HPMC capsules, printed in
white ink
with “BLU-667” on the capsule shell body and “100mg” on the
capsule shell cap,
containing white to off white powder.
1.3
ROUTE OF ADMINISTRATION
Oral
1.4
STERILE / RADIOACTIVE STATEMENT
Not applicable
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient(s):_ pralsetinib
_Excipients: _
_Capsule content: hydroxypropyl methylcellulose, microcrystalline
cellulose, sodium _
_bicarbonate, citric acid, anhydrous, magnesium stearate,
pregelatinized starch. _
_Capsule shell: hypromellose, titanium dioxide, FD&C Blue #1
(Brilliant Blue FCF) _
_Printing ink: _shellac, dehydrated alcohol, isopropyl alcohol, butyl
alcohol, propylene
glycol, strong ammonia solution, purified water, potassium hydroxide,
and titanium
dioxide.
2
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
_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.
2.2
DOSAGE AND ADMINISTRATION
_GENERAL _
A validated assay is required for the selection of patients with a
_RET_-gene fusion
(NSCLC) or a _RET_-gene mutation (MTC).
_DOSAGE _
Gavreto hard capsules should be taken on an empty stomach. Do not to
eat for
at least 2 hours before and at least 1 hour after taking Gavreto.
Gavreto hard capsules should be swallowed whole with a glass of water
and must not be
opened or chewed.
_ADULTS _
The recommended dose of Gavreto for adults