PIQRAY 150 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

ALPELISIB

متاح من:

NOVARTIS ISRAEL LTD

ATC رمز:

L01XX65

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

ALPELISIB 150 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

المجال العلاجي:

ALPELISIB

الخصائص العلاجية:

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

تاريخ الترخيص:

2020-12-06

نشرة المعلومات

Artwork Order No.:
Artwork Order description:
AW identifier No. New:
Proof No.:
Dimension:
Tech. Drawing No.:
Live text:
Condensed font:
Font type:
Creation date:
Artwork creator:
Braille:
Printing colours:
Technical colours:
Print enhancements:
AW identifier No. Old:
Packaging site:
Minimum font size body text:
Variable data prefixes font size:
!
P L E A S E
T U R N
O V E R P R I
N T I
N G
O N
!
730 X 289 MM
Yes No Both
Artwork Service Provider
Black
Yes No
Arial
8 pt
Nurit Assayag
31/07/22
Leaflet-Piqray
1
X
DOR
730x289 (60x110) -
PIQRAYBYL719.
pdf
:ة
ّ
يفاضإ ةيبناج ضارعأ
:)نيلمعتسم 10 نيب نم دحاو لمعتسم نم رثكأ
يف رثؤت دق( (
VERY COMMON ( ادج ةعئاش ةيبناج ضارعأ
-
حفط
-
نايثغ
-
فعضو بعت
-
ة
ّ
يهشلا ضافخنا
-
ؤيقت
-
نزولا ضافخنا
-
رعشلا طقاست
-
)ةيومف حورقو )aphtha( علاق ،ةيومف حورج كلذ
يف امب ،مفلا يف ةيطاخملا ةيشغلأا
باهتلا( مفلا باهتلا
-
مضهلا رسع
-
ةيطاخملا ةيشغلأا باهتلا
-
ةيطيحم ةمذو
-
ةعفترم ةرارح
-
)جرفلاو لبهملا فافج ،مفلا فافج ىلع
لمتشي( ةيطاخملا ةيشغلأا فافج
-
)ةمعطلأا هاجت ةيساسحلا ضافخناو ق
ُّ
وذتلا ةساح نادقف كلذ يف امب( ق
ّ
وذتلا ةساح يف تابارطضا
-
عادص
-
ةكح
-
فاج دلج
-
نطبلا يف م
َ
لأ
-
:مدلا تاصوحف ضعب يف تارييغت
•
زابيل ،نينلالأا نيمأ ةلقان ،ليماتولچ
اماچ ديتببلا ةلقان :مدلا يف ةيلاتلا
تاميزنلإا نم ةعفترم تايوتسم
•
مدلا يف عفترم نينيتايرك ىوتسم
•
مدلا يف نيموبللأا وأ/و نيبولچوميهلا
،زوكولﭽلا ،ةيومدلا حئافصلا
،تايوافمللا نم مدلا يف ضفخنم ىوتسم
•
)مدلا رثخت ءادلأ رشؤم -
ac

خصائص المنتج

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