PIQRAY 150 MG

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

ALPELISIB

Διαθέσιμο από:

NOVARTIS ISRAEL LTD

Φαρμακολογική κατηγορία (ATC):

L01XX65

Φαρμακοτεχνική μορφή:

FILM COATED TABLETS

Σύνθεση:

ALPELISIB 150 MG

Οδός χορήγησης:

PER OS

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

Θεραπευτική περιοχή:

ALPELISIB

Θεραπευτικές ενδείξεις:

PIQRAY is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CAmutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen

Ημερομηνία της άδειας:

2020-12-06

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Αρχείο Π.Χ.Π.

PIQ API JAN23 V5
USPI NOV2022
FULL PRESCRIBING INFORMATION
1
NAME OF THE MEDICINAL PRODUCT
PIQRAY 50 MG
PIQRAY 150 MG
PIQRAY 200 MG 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH FILM-COATED TABLET CONTAINS:
Piqray 50 mg: alpelisib 50 mg
Piqray 150 mg: alpelisib 150 mg
Piqray 200 mg: alpelisib 200 mg
For the full list of excipients, see section 12. 3 PHARMACEUTICAL FORM
Film-Coated Tablets
50 mg: light pink, unscored, round, curved film-coated tablet with
beveled
edges, imprinted with “L7” on one side and “NVR” on the other
side.
150 mg: pale red, unscored, ovaloid, curved film-coated tablet with
beveled
edges, imprinted with “UL7” on one side and “NVR” on the other
side.
Piqray 200 mg: light red,
unscored
,
ovaloid, curved film-coated tablet with beveled
edges, imprinted with “YL7” on one side and “NVR” on the other
side.
4 THERAPEUTIC INDICATIONS
PIQRAY is indicated in combination with fulvestrant for the treatment
of postmenopausal
women, and men, with hormone receptor (HR)-positive, human epidermal
growth factor
receptor 2 (HER2)-negative, PIK3CA- mutated, advanced or metastatic
breast cancer
following progression on or after an endocrine-based regimen.
5 DOSAGE AND ADMINISTRATION
5.1 PATIENT SELECTION
Select patients for the treatment of HR-positive, HER2-negative
advanced or metastatic
breast cancer with PIQRAY, based on the presence of one or more PIK3CA
mutations in
tumor tissue or plasma specimens
_[see Clinical Studies (15)]_
. If no mutation is detected in
a plasma specimen, test tumor tissue.
PIQ API JAN23 V5
USPI NOV2022 5.2 DOSAGE AND ADMINISTRATION
The recommended dose of PIQRAY is 300 mg (two 150 mg film-coated
tablets) taken
orally, once daily, with food
_[see Clinical Pharmacology (13.3)]_
.
Continue treatment until disease progression or unacceptable toxicity
occurs
_[see _
_Dosage and Administration (5.3)]_
.
Patients should take their dose of PIQRAY at approximately the same
time each day.
Swallow PIQRAY tablets whole (tablets should not be chewed, crushed or
split pr