IBRANCE palbociclib 125 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

palbociclib, Quantity: 125 mg

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

palbociclib

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: Gelatin; sodium starch glycollate type A; iron oxide yellow; silicon dioxide; magnesium stearate; titanium dioxide; iron oxide red; lactose monohydrate; microcrystalline cellulose; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; simethicone; ethanol; Shellac; sulfuric acid

Administration route:

Oral

Units in package:

21

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

IBRANCE is indicated for the treatment of 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 ? fulvestrant in patients who have received prior therapy.

Product summary:

Visual Identification: Opaque, hard capsule, with a caramel body (printed "PBC 125" in white) and a caramel cap (printed "Pfizer" in white); Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-05-03

Patient Information leaflet

IBRANCE
®
_Palbociclib_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about IBRANCE.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking IBRANCE
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IBRANCE IS
USED FOR
_WHAT IBRANCE DOES_
IBRANCE is used to treat patients
with hormone receptor-positive (HR-
positive), human epidermal growth
factor receptor 2 negative (HER2-
negative) advanced breast cancer. It
is given together with an aromatase
inhibitor or fulvestrant, which are
used as hormonal anticancer
therapies.
IBRANCE belongs to a group of
medicines called cyclin-dependent
kinase inhibitors.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
IBRANCE is only available with a
doctor's prescription.
It is not addictive.
_USE IN CHILDREN_
The safety and efficacy of IBRANCE
in children have not been established.
BEFORE YOU TAKE
IBRANCE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE IBRANCE IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
palbociclib
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expired or is damaged, return
it to your pharmacist for disposal.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START TAKING THIS MEDICINE,
TALK TO YOUR DOCTOR.
_BEFORE YOU START TO TAKE IT_
TELL YOUR DOCTO

Summary of Product characteristics

Version: pfpibrac10620
Supersedes: pfpibrac11119
Page 1 of 35
AUSTRALIAN
PRODUCT
INFORMATION
–
IBRANCE® (PALBOCICLIB)
1.
NAME OF THE MEDICINE
Palbociclib
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each IBRANCE tablet contains palbociclib 75 mg, 100 mg or 125 mg.
Each IBRANCE capsule contains palbociclib 75 mg, 100 mg or 125 mg.
EXCIPIENTS WITH KNOWN EFFECT
IBRANCE capsules contain lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
IBRANCE is supplied as hard capsules or a film-coated tablets for oral
administration.
75 mg strength: Opaque, hard capsule with a light orange body (printed
“PBC 75” in white)
and a light orange cap (printed “Pfizer” in white). Round, light
purple, film-coated tablet
debossed with “Pfizer” on one side and “PBC 75” on the other
side.
100 mg strength: Opaque, hard capsule with a light orange body
(printed “PBC 100” in white)
and a caramel cap (printed “Pfizer” in white). Oval, green,
film-coated tablet debossed with
“Pfizer” on one side and “PBC 100” on the other side.
125 mg strength: Opaque, hard capsule with a caramel body (printed
“PBC 125” in white) and
a caramel cap (printed “Pfizer” in white). Oval, light purple,
film-coated tablet debossed with
“Pfizer” on one side and “PBC 125” on the other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
IBRANCE is indicated for the treatment of 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
•
fulvestrant in patients who have received prior therapy.
Version: pfpibrac10620
Supersedes: pfpibrac11119
Page 2 of 35
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The recommended dose of IBRANCE is a 125 mg capsule or tablet taken
orally once daily for
21 consecutive days followed by 7 days off treatment to comprise a
complete cycle of 28 days.
When
coadministered
with
pal