Land: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
Ruxolitinib phosphate
Novartis Pharmaceuticals Australia Pty Ltd
Medicine Registered
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 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 spleen size in patients with different forms of myelofibrosis and relieve the symptoms. 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. Jakavi is not addictive. Jakavi is available only with a doctor's prescription. There is not enough information to recommend the use of this medicine for Lestu allt skjalið
1 JAKAVI RUXOLITINIB NAME OF THE MEDICINE STRUCTURAL FORMULA: The active ingredient of Jakavi is ruxolitinib (as the phosphate salt) or (_R_)-3-(4-(7_H_- Pyrrolo[2,3-_d_]pyrimidin-4-yl)-1_H_-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate INN: ruxolitinib CAS NAME .: 1H-Pyrazole-1-propanenitrile, β-cyclopentyl-4-(7H-pyrrolo[2,3- d]pyrimidin-4-yl)-, (βR)-, phosphate (1:1); 941678-49-5 CAS NUMBER.: 1092939-17-7 MOLECULAR FORMULA: C 17 H 18 N 6 MOLECULAR WEIGHT OF THE PHOSPHATE SALT: 404.36 MOLECULAR WEIGHT OF THE FREE BASE: 306.37 DESCRIPTION Ruxolitinib phosphate is a white to almost white powder. It is highly soluble in water, most soluble at low pH (pH 3.3) at 37 o C. The pKa is 4.3 and 11.8. The BCS is Class 1. Jakavi tablets contain 5 mg, 15 mg and 20 mg of ruxolitinib as the phosphate salt. EXCIPIENTS Jakavi tablets contain the following excipients: cellulose, microcrystalline; magnesium stearate; silica, colloidal anhydrous; sodium starch glycollate type A; hydroxypropylcellulose; povidone; lactose. 2 PHARMACOLOGY MECHANISM OF ACTION (MOA) Ruxolitinib is an inhibitor of the Janus Associated Kinases (JAKs) JAK1 and JAK2 with nanomolar potency. JAKs mediate the signaling of a number of cytokines and growth factors that are important for haematopoiesis and immune function. JAK signalling involves recruitment of STATs (signal transducers and activators of transcription) to cytokine receptors, activation, and subsequen Lestu allt skjalið