Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
ruxolitinib phosphate
Novartis Pharmaceuticals Australia Pty Ltd
Ruxolitinib phosphate
Registered
1 AUSTRALIAN PRODUCT INFORMATION - JAKAVI (RUXOLITINIB) 1. NAME OF THE MEDICINE Australian Approved Name: ruxolitinib 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Jakavi tablets contain 5 mg, 10mg, 15 mg and 20 mg of ruxolitinib as the phosphate salt. Ruxolitinib phosphate is a white to almost white powder. Excipients with known effects: Contains sugars, as lactose monohydrate. For the full list of excipients, section 6.1 List of excipients. 3. PHARMACEUTICAL FORM 5MG TABLET: Round curved white to almost white tablets of approximately 7.5 mm in diameter with “NVR” debossed on one side and “L5” debossed on the other side. 10MG TABLET: Round curved white to almost white tablets of approximately 9.3 mm in diameter with “NVR” debossed on one side and “L10” debossed on the other side. 15 MG TABLET: Ovaloid curved white to almost white tablets of approximately 15.0 x 7.0 mm with “NVR” debossed on one side and “L15” debossed on the other side. 20 MG TABLET: Elongated curved white to almost white tablets of approximately 16.5 x 7.4 mm with “NVR” debossed one one side and “L20” debossed on the other side,. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Jakavi ® is indicated for the treatment of disease-related splenomegaly or symptoms in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. Jakavi ® is indicated for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea. 4.2 DOSE AND METHOD OF ADMINISTRATION MONITORING INSTRUCTIONS BLOOD CELL COUNTS: a blood cell count must be performed before initiating therapy with Jakavi. Complete blood counts should be monitored every 2 to 4 weeks until doses are stabilized, and then as clinically indicated (see Precautions section). 2 DOSE Jakavi is given orally twice daily with or without food in Myelofibrosis. The recommended starting dose is based on platelet count (Table 1). TABLE 1 RECOMMENDED JAKAVI STARTING DOSE PLATEL Lees het volledige document