IBRANCE palbociclib 100 mg tablet blister pack

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

palbociclib, Quantity: 100 mg

Dostępny od:

Pfizer Australia Pty Ltd

Forma farmaceutyczna:

Tablet, film coated

Skład:

Excipient Ingredients: microcrystalline cellulose; silicon dioxide; crospovidone; magnesium stearate; succinic acid; titanium dioxide; hypromellose; triacetin; iron oxide yellow; indigo carmine aluminium lake

Droga podania:

Oral

Sztuk w opakowaniu:

21

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

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.

Podsumowanie produktu:

Visual Identification: Oval, green, film-coated tablet with Pfizer debossed on one side and PBC 100 debossed on other side.; Container Type: Blister Pack; Container Material: Other plastic laminate/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Status autoryzacji:

Registered

Data autoryzacji:

2020-06-16

Ulotka dla pacjenta

IBRANCE
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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 USING IBRANCE?
IBRANCE contains the active ingredient palbociclib. IBRANCE is used to
treat advanced breast cancer.
For more information, see Section 1. Why am I using IBRANCE? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE 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 use
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 USE 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 use IBRANCE? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING IBRANCE?
THINGS YOU
SHOULD DO
•
Remind any doctor, pharmacist or dentist you visit that you are using
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
•

Charakterystyka produktu

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