Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
axitinib, Quantity: 5 mg
Pfizer Australia Pty Ltd
Axitinib
Tablet, film coated
Excipient Ingredients: lactose monohydrate; croscarmellose sodium; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; triacetin; iron oxide red
Oral
28 tablets, 56 tablets
(S4) Prescription Only Medicine
For the treatment of patients with advanced renal cell carcinoma after failure of one prior systemic therapy
Visual Identification: Red, triangular, film-coated tablet debossed with "Pfizer" on one side and "5 XNB" on the other.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2012-07-26
INLYTA ® _Axitinib_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about INLYTA. 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 INLYTA 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 INLYTA IS USED FOR _WHAT INLYTA DOES_ INLYTA is used to treat a certain type of kidney cancer called renal cell carcinoma (RCC). It belongs to a group of medicines called tyrosine kinase inhibitors. _HOW INLYTA WORKS_ INLYTA contains the active substance axitinib. It works by reducing the blood supply to the tumour and slowing down the growth of cancer. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY INLYTA HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. INLYTA is only available with a doctor's prescription. It is not addictive. _USE IN CHILDREN_ The safety and efficacy of INLYTA have not been established in children. BEFORE YOU TAKE INLYTA _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE INLYTA IF YOU HAVE AN ALLERGY TO: • any medicine containing axitinib • 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 DOCTOR IF YOU HAVE ALLERGIES TO ANY OTHER MEDICINES, FOODS, PRESERVATIVES OR D Przeczytaj cały dokument
Version: pfpinlyt21019 Supersedes: pfpinlyt11019 Page 1 of 20 AUSTRALIAN PRODUCT INFORMATION – INLYTA ® (AXITINIB) 1. NAME OF THE MEDICINE Axitinib 2. QUALITATIVE AND QUANTITATIVE COMPOSITION INLYTA is supplied as red film-coated tablets containing 1 mg, 3 mg, 5 mg, or 7 mg of axitinib. EXCIPIENT(S) WITH KNOWN EFFECT lactose monohydrate For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM INLYTA 1 MG TABLETS Red, film-coated, oval tablets, debossed with “Pfizer” on one side and “1 XNB” on the other. INLYTA 3 MG TABLETS Red, film-coated, round tablets, debossed with “Pfizer” on one side and “3 XNB” on the other. INLYTA 5 MG TABLETS Red, film-coated, triangular tablets, debossed with “Pfizer” on one side and “5 XNB” on the other. INLYTA 7 MG TABLETS Red, film-coated, diamond tablets, debossed with “Pfizer” on one side and “7 XNB” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS INLYTA is indicated for the treatment of patients with advanced renal cell carcinoma after failure of one prior systemic therapy. Version: pfpinlyt21019 Supersedes: pfpinlyt11019 Page 2 of 20 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE RECOMMENDED DOSE The recommended starting oral dose of INLYTA is 5 mg twice daily. INLYTA may be taken with or without food. If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time. DOSAGE ADJUSTMENT Dose increase or reduction is recommended based on individual safety and tolerability. Patients who tolerate the INLYTA starting dose of 5 mg twice daily with no adverse reactions >Grade 2 (according to the Common Toxicity Criteria for Adverse Events [CTCAE]) for two consecutive weeks, are normotensive, and are not receiving anti-hypertensive medication, may have their dose increased to 7 mg twice daily. Subsequently, using the same criteria, patients who tolerate the INLYTA dose of 7 mg twice daily, may have their dose increased to a maximum Przeczytaj cały dokument