Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
axitinib, Quantity: 5 mg
Pfizer Australia Pty Ltd
Axitinib
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; magnesium stearate; croscarmellose sodium; lactose monohydrate; titanium dioxide; hypromellose; triacetin; iron oxide red
Oral
60 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: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2012-07-26
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 Belgenin tamamını okuyun