IBRANCE TABLETS 125 MG

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

PALBOCICLIB

MAH:

PFIZER PHARMACEUTICALS ISRAEL LTD

ATC_code:

L01XE33

pharmaceutical_form:

FILM COATED TABLETS

composition:

PALBOCICLIB 125 MG

administration_route:

PER OS

prescription_type:

Required

manufactured_by:

PFIZER INC, USA

therapeutic_area:

PALBOCICLIB

therapeutic_indication:

IBRANCE is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:* an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men; or* fulvestrant in patients with disease progression following endocrine therapy.

authorization_date:

2023-06-22

PIL

Ibrance tablets, PIL, Israel, CC TC 021123
2023-0088988
1
PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a
doctor’s
prescription only
IBRANCE
® TABLETS 75 MG
IBRANCE
® TABLETS 100 MG
IBRANCE
® TABLETS 125 MG
FILM-COATED TABLETS
Each tablet contains:
palbociclib 75 mg, 100 mg or 125 mg
List of inactive ingredients and allergens in the preparation: see
section 6 'Further information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE 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.
This medicine is intended for women and men over the age of 18.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Ibrance is intended for the treatment of estrogen receptor-positive
and HER2-negative advanced or
metastatic breast cancer, in combination with:
●
An aromatase inhibitor as initial (endocrine-based) combination
therapy in postmenopausal
women or in men.
OR
●
Fulvestrant in patients with disease progression following previous
endocrine therapy.
THERAPEUTIC GROUP: antineoplastic, kinase inhibitor.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
●
you are sensitive (allergic) to the active ingredient or to any of the
other ingredients in this
medicine (listed in section 6).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE:
BEFORE TREATMENT WITH IBRANCE, TELL YOUR DOCTOR IF:
●
you have fever, chills, or any other symptom of infection.
●
you have impaired liver or kidney function.
●
you are pregnant or plan to become pregnant. For more information, see
section 2 under
'Pregnancy, breastfeeding and fertility'.
●
you are breastfeeding or plan to breastfeed. For more information, see
section 2 under
'Pregnancy, breastfeeding and fertility'.
Tell your doctor if you are taking Ibrance and

SPC

Ibrance tablets 75 mg, 100 mg, 125 mg, LPD, Israel, CC 041223
2022-0077820, 2023-0084987, 2022-0082924
1
FULL PRESCRIBING INFORMATION
NAME OF THE MEDICINAL PRODUCT
Ibrance
®
tablets 75 mg
Ibrance
®
tablets 100 mg
Ibrance
®
tablets 125 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 75 mg, 100 mg or 125 mg Palbociclib
For the full list of excipients, see section 11.
PHARMACEUTICAL FORM
Film coated tablets
1
INDICATIONS AND USAGE
IBRANCE is indicated for the treatment of adult patients with hormone
receptor
(HR)-positive, human epidermal growth factor receptor 2
(HER2)-negative advanced or
metastatic breast cancer in combination with:
•
an aromatase inhibitor as initial endocrine-based therapy in
postmenopausal women or in
men; or
•
fulvestrant in patients with disease progression following endocrine
therapy.
2
DOSAGE AND ADMINISTRATION
2.1
Recommended Dose and Schedule
The recommended dose of IBRANCE is a 125 mg tablet taken orally once
daily for
21 consecutive days followed by 7 days off treatment to comprise a
complete cycle of
28 days. IBRANCE tablet may be taken with or without food _[see
Clinical Pharmacology _
_(12.3)]_.
Administer the recommended dose of an aromatase inhibitor when given
with IBRANCE.
Please refer to the Full Prescribing Information for the aromatase
inhibitor being used.
When given with IBRANCE, the recommended dose of fulvestrant is 500 mg
administered
on Days 1, 15, 29, and once monthly thereafter. Please refer to the
Full Prescribing
Information of fulvestrant.
Patients should be encouraged to take their dose of IBRANCE at
approximately the same
time each day.
If the patient vomits or misses a dose, an additional dose should not
be taken. The next
prescribed dose should be taken at the usual time. IBRANCE tablets
should be swallowed
Ibrance tablets 75 mg, 100 mg, 125 mg, LPD, Israel, CC 041223
2022-0077820, 2023-0084987, 2022-0082924
2
whole (do not chew, crush, or split them prior to swallowing). Tablets
should not be ingested
if they are broken, cra