Jakavi® (ruxolitinib) is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases. Jakavi is approved by the European Commission for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea and for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis1.
Myelofibrosis is a disorder of the bone marrow, in which the marrow is replaced by scar tissue. Since the abnormal marrow can no longer produce enough normal blood cells, the spleen often becomes enlarged when it takes responsibility for blood cell creation2. Patients may also suffer debilitating symptoms, including fatigue/weakness, shortness of breath, fever/night sweats, itchy skin, bone/joint pain, abdominal pain and/or weight loss, and have a poor quality of life and shortened survival2,3,4. Jakavi directly targets the underlying mechanism of disease, significantly reducing the size of the spleen in patients with myelofibrosis and relieving symptoms regardless of JAK mutational status, disease subtype, or any prior treatment, including hydroxyurea1.
Polycythemia Vera (PV)
PV is a rare and incurable blood cancer associated with an overproduction of blood cells in the bone marrow that can cause serious cardiovascular complications, such as blood clots, stroke and heart attack5. Approximately 25% of patients with PV develop resistance to or intolerance of hydroxyurea and are considered to have uncontrolled disease6. This is typically defined as hematocrit levels greater than 45%, elevated white blood cell count and/or platelet count, and may be accompanied by debilitating symptoms and/or an enlarged spleen6,7,8. Jakavi has shown to improve two key measures of disease control, including hematocrit control without use of phlebotomy and spleen size reduction, and improved PV-related symptoms in adult patients with PV who are resistant to or intolerant of hydroxyurea9.
This information is based on the European Summary of Product Characteristics. The prescribing information in your country may vary; please consult your local prescribing information and/or contact your local Novartis representative.
Novartis licensed ruxolitinib from Incyte Corporation for development and commercialization outside the United States. Jakavi is marketed in the United States by Incyte Corporation as Jakafi® for the treatment of patients with PV who have had an inadequate response to or are intolerant of hydroxyurea and for the treatment of patients with intermediate or high-risk myelofibrosis. The safety and efficacy profile of Jakavi has not yet been established outside the approved indications.
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Jakavi Important Safety Information for Treatment of Myelofibrosis (MF) and Polycythemia Vera (PV)
Jakavi can cause serious side effects, including a decrease in blood cell count and infections. Complete blood count monitoring is recommended. Dose reduction or interruption may be required in patients with any hepatic impairment or severe renal impairment or in patients developing hematologic adverse reactions such as thrombocytopenia, anemia and neutropenia. Dose reductions are also recommended when Jakavi is co-administered with strong CYP3A4 inhibitors or fluconazole. Use of Jakavi during pregnancy is not recommended, and women should avoid becoming pregnant during Jakavi therapy. Women taking Jakavi should not breast feed. Progressive multifocal leukoencephalopathy (PML) has been reported. Physicians should be alert for neuropsychiatric symptoms suggestive of PML. Hepatitis B viral load (HBV-DNA titer) increases have been reported in patients with chronic HBV infections. Patients with chronic HBV infection should be treated and monitored according to clinical guidelines. Non-melanoma skin cancer (NMSC) has been reported in Jakavi treated patients. Periodic skin examination is recommended. Very common adverse reactions in MF (>10%) include urinary tract infections, anemia, thrombocytopenia, neutropenia, hypercholesterolemia, dizziness, headache, alanine aminotransferase increased, aspartate aminotransferase increased, bruising and weight gain. Common adverse reactions in MF (1 to 10%) include herpes zoster and flatulence. Uncommon adverse reactions in MF include tuberculosis. Very common adverse reactions in PV (>10%) include anemia, thrombocytopenia, hypercholesterolemia, hypertriglyceridemia, dizziness, alanine aminotransferase increased and aspartate aminotransferase increased. Common adverse reactions in PV (1 to 10%) include urinary tract infections, herpes zoster, weight gain, constipation and hypertension.
Jakavi® (ruxolitinib) tablets: EU Summary of Product Characteristics. Novartis; Mar 2015.
Mesa RA, Schwagera S, Radia D, et al. The Myelofibrosis Symptom Assessment Form (MFSAF): An Evidence-Based Brief Inventory to Measure Quality of Life and Symptomatic Response to Treatment in Myelofibrosis. Leuk Res. 2009; 33:1199-1203.
Cervantes F, Dupriez B, Pereira A, et al. New Prognostic Scoring System for Primary Myelofibrosis Based on a Study of the International Working Group for Myelofibrosis Research and Treatment. Blood. 2009; 113:2895–2901.
Alvarez-Larran A, Pereira A, Cervantes F, et al. Assessment and Prognostic Value of The European Leukemianet Criteria for Clinicohematologic Response, Resistance, and Intolerance to Hydroxyurea in Polycythemia Vera. Blood. 2012; 119(6):1363–1369.
Barbui T, Barosi G, Birgegard G, et al. Philadelphia-Negative Classical Myeloproliferative Neoplasms; Critical Concepts and Management Recommendations from European LeukemiaNET. J Clin Oncol. 2011; 29(6):761–770.
Emanuel R, Dueck A, Geyer H, et al. Myeloproliferative Neoplasm (MPN) Symptom Assessment Form Total Symptom Score: Prospective International Assessment of an Abbreviated Symptom Burden Scoring System Among Patients with MPNs. J Clin Oncol. 2012; 30(33):4098–4103.
Vannucchi A, et al. Ruxolitinib versus Standard Therapy for the Treatment of Polycythemia Vera. The New England Journal of Medicine. 2015; 372:426–35.