Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
ruxolitinib phosphate, Quantity: 26.4 mg (Equivalent: ruxolitinib, Qty 20 mg)
Novartis Pharmaceuticals Australia Pty Ltd
Ruxolitinib phosphate
Tablet
Excipient Ingredients: colloidal anhydrous silica; microcrystalline cellulose; hyprolose; magnesium stearate; lactose monohydrate; sodium starch glycollate type A; povidone
Oral
112, 56, 224, 168, 28, 14
(S4) Prescription Only Medicine
Jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis.,Jakavi is indicated for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea.,Jakavi is indicated for the treatment of patients aged 12 years and older with acute graft-versus-host disease who have inadequate response to corticosteroids.,Jakavi is indicated for the treatment of patients aged 12 years and older with chronic graft-versus-host disease who have inadequate response to corticosteroids.
Visual Identification: Elongated curved white to almost white tablet with NVR debossed on one side and L20 debossed on the other side; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2013-07-03
JAKAVI ® (JAK-AH-FYE) _Ruxolitinib phosphate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Jakavi. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET FROM WWW.NOVARTIS.COM.AU. Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will provide. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT JAKAVI IS USED FOR Jakavi is used to treat adult patients with myelofibrosis, a rare form of blood disorder with a variety of symptoms such as fever, night sweats, bone pain, weight loss. Enlarged spleen is one of the characteristics of myelofibrosis. Jakavi is also used to treat patients with polycythemia vera who are intolerant of or not controlled with hydroxyurea. Polycythemia vera is a rare serious blood disorder with a variety of troublesome symptoms such as itching (pruritus), headache, vision problems, severe burning pain in the hands or feet, and blood vessels clots. Enlarged spleen is also sometimes present in patients with polycythemia vera. Jakavi contains the active substance ruxolitinib phosphate. This medicine belongs to a group of medicines called Jak inhibitors. Myelofibrosis is a disorder of the bone marrow, in which the marrow is replaced by scar tissue. The abnormal marrow can no longer produce enough normal blood cells and results in a significantly enlarged spleen. Jakavi can reduce Read the complete document
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 section 4.4. Special warnings and precautions for use). 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 Read the complete document