Ibrance 75 mg

Country: Jordan

Language: English

Source: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Active ingredient:

Palbociclib 75 mg

Available from:

مستودع البتراء للمواد الطبية - Petra Drug Store

ATC code:

L01XE33

INN (International Name):

Palbociclib 75 mg

Dosage:

75 mg

Units in package:

21 Capsule

Manufactured by:

Pfizer Manufacturing Deutschland GmbH/Germany (المانيا)

Patient Information leaflet

PAA139441
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IBRANCE
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR IBRANCE.
IBRANCE
® (PALBOCICLIB) CAPSULES, FOR ORAL USE
------------------------------ RECENT MAJOR CHANGES
------------------------------
Dosage and Administration (2.2)
9/2019
Warnings and Precautions (5.2)
9/2019
------------------------------ INDICATIONS AND USAGE
-------------------------------
IBRANCE is a kinase inhibitor 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
•
fulvestrant in women with disease progression following endocrine
therapy. (1)
--------------------------- DOSAGE AND ADMINISTRATION
--------------------------
IBRANCE capsules are taken orally with food in combination with an
aromatase
inhibitor or fulvestrant. (2)
•
Recommended starting dose: 125 mg once daily taken with food for 21
days
followed by 7 days off treatment. (2.1)
•
Dosing interruption and/or dose reductions are recommended based on
individual safety and tolerability. (2.2)
------------------------ DOSAGE FORMS AND STRENGTHS
--------------------------
Capsules: 125 mg, 100 mg, and 75 mg. (3)
-------------------------------- CONTRAINDICATIONS
----------------------------------
None. (4)
--------------------------- WARNINGS AND PRECAUTIONS
---------------------------
•
Neutropenia: Monitor complete blood count prior to start of IBRANCE
therapy
and at the beginning of each cycle, as well as on Day 15 of the first
2 cycles,
and as clinically indicated. (2.2, 5.1)
•
Interstitial Lung Disease (ILD)/Pneumonitis: Severe and fatal cases of
ILD/
pneumonitis have been reported. Monitor for pulmonary symptoms of ILD/
pneumonitis. Interrupt IBRANCE immediately in patients with suspected
ILD/
pneumonitis. Permanently