País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
palbociclib, Quantity: 100 mg
Pfizer Australia Pty Ltd
palbociclib
Capsule, hard
Excipient Ingredients: magnesium stearate; iron oxide yellow; silicon dioxide; iron oxide red; microcrystalline cellulose; sodium starch glycollate type A; lactose monohydrate; titanium dioxide; Gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; simethicone; ethanol; Shellac; sulfuric acid
Oral
21
(S4) Prescription Only Medicine
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.
Visual Identification: Opaque, hard capsule, with a light orange body (printed "PBC 100" 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
Licence status A
2017-05-03
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 Llegiu el document complet
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 Llegiu el document complet