Ibrance

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Palbociclib 125mg

Available from:

Pfizer New Zealand Limited

INN (International Name):

Palbociclib 125 mg

Dosage:

125 mg

Pharmaceutical form:

Capsule

Composition:

Active: Palbociclib 125mg Excipient: Colloidal silicon dioxide Gelatin   Iron oxide red   Iron oxide yellow   Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opacode white S-1-7085 Sodium starch glycolate Titanium dioxide  

Prescription type:

Prescription

Manufactured by:

Pfizer Ireland Pharmaceuticals

Therapeutic indications:

Ibrance is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer: - in combination with an aromatase inhibitor; - in combination with fulvestrant in women who have received prior endocrine therapy. In pre- or peri-menopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PCTFE/PVC with aluminium foil lidding material - 21 capsules - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, opaque LDPE with PP CRC - 21 capsules - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2016-11-10

Patient Information leaflet

IBRANCE®
1
IBRANCE
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING IBRANCE?
IBRANCE contains the active ingredient palbociclib. IBRANCE is used to
treat advanced breast cancer.
For more information, see Section 1. Why am I taking IBRANCE?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE IBRANCE?
Do not use if you have ever had an allergic reaction to palbociclib or
any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become
pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I take
IBRANCE?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines and IBRANCE may interfere with each other. It is
important you tell your doctor or pharmacist if you are taking
any medicines used to treat fungal or bacterial infections, HIV/AIDS
infections, hepatitis C, tuberculosis, certain heart conditions
or high blood pressure, epilepsy/seizures and depression and sleep
disorders.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I TAKE IBRANCE?
•
IBRANCE is a tablet and is taken by mouth.
•
Your doctor will advise how much IBRANCE to use depending on your
medical condition.
•
Detailed instructions on how to take IBRANCE are provided in the
'Instructions for Use' leaflet inside the pack.
More instructions can be found in Section 4. How do I take IBRANCE?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING IBRANCE?
THINGS YOU
SHOULD DO
•
Remind any doctor, pharmacist or dentist you visit that you are taking
IBRANCE.
•
Check with your doctor before you receive any vaccines.
•
Use a reliable method of contraception during treatment with IBRANCE.
•
It is important to tell your doctor if you get symptoms of an
infection.
THINGS YOU
SHOULD NOT DO
�

Summary of Product characteristics

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NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
IBRANCE
®
palbociclib 75 mg capsules
IBRANCE
®
palbociclib 100 mg capsules
IBRANCE
®
palbociclib 125 mg capsules
IBRANCE
®
palbociclib 75 mg tablets
IBRANCE
®
palbociclib 100 mg tablets
IBRANCE
®
palbociclib 125 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each IBRANCE capsule contains palbociclib 75 mg, 100 mg or 125 mg.
Each IBRANCE tablet contains palbociclib 75 mg, 100 mg or 125 mg.
_EXCIPIENT(S) WITH KNOWN EFFECT_
IBRANCE capsules contain lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
IBRANCE is supplied as hard capsules or 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 locally advanced or
metastatic breast cancer:

in combination with an aromatase inhibitor;

in combination with fulvestrant in women who have received prior
endocrine therapy.
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Page 2 of 28
In pre- or perimenopausal women, the endocrine therapy should be
combined with a luteinizin