Prescribing information


For your myelofibrosis patients with disease-related splenomegaly or symptoms1,2

JAKAVI® is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. JAKAVI® is also indicated for adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.1



JAKAVI® is the only JAK inhibitor approved for MF with up to 5 years follow-up data§1,2,7

*Patients treated with JAKAVI® achieved a reduction in spleen length at Week 4. This was confirmed by a reduction in spleen volume at Week 24, which was maintained to Week 48. Patients treated with JAKAVI® achieved an improvement in symptoms at Week 4, which was maintained to Week 24. The median time to first CT/MRI observation of a ≥35% reduction in spleen size was 12.3 weeks.2,3
Spleen response was defined as a baseline splenomegaly that is palpable at 5–10 cm becoming not palpable, or a baseline splenomegaly that is palpable at >10 cm decreasing by ≥50%. Benefit must last ≥12 weeks. Baseline splenomegaly that is palpable at ≤5 cm is not eligible for response. Response was confirmed by MRI or CT observation of a ≥35% reduction in spleen size.10
Estimated 5-year survival in COMFORT-II: 56% JAKAVI® vs 44% BAT (crossover corrected), HR=0.44, 95% CI (0.18–1.04), p=0.06 (not significant, for descriptive purposes only).7
§As of February 22nd 2021.9

BAT, best available therapy; BSH, British Society for Haematology; CI, confidence interval; COMFORT, Controlled Myelofibrosis Study with Oral JAK Inhibitor Treatment; CT, computed tomography; HR, hazard ratio; JAK, janus kinase; MF, myelofibrosis; MRI, magnetic resonance imaging.

  1. Novartis Pharmaceuticals UK Ltd. JAKAVI® summary of product characteristics.
  2. Verstovsek S, et al. N Engl J Med. 2012;366:799–807.
  3. Harrison C, et al. N Engl J Med. 2012;366:787–798.
  4. Reilly J, et al. Br J Haematol. 2014;167:418–438.
  5. National Institute for Health and Care Excellence. Ruxolitinib for treating disease-related splenomegaly or symptoms in adults with myelofibrosis. TA386, 2016. Available at: [Accessed February 2022].
  6. Scottish Medicines Consortium. Ruxolitinib (as phosphate), 5 mg, 15 mg, & 20 mg tablets (JAKAVI®). SMC No 867/13, 2015. Available at: [Accessed February 2022].
  7. Harrison C, et al. Leukemia. 2016;30:1701–1707.
  8. Vannucchi A and Harrison C. Blood. 2017;129:693–703.
  9. Data on file. Novartis (Periodic safety update report, 2021).
  10. Polverelli N, et al. EHA 2016, 9–12 June; Copenhagen, Denmark. Poster P672.

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UK | February 2022 | 172653

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Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to Novartis via or online through the pharmacovigilance intake (PVI) tool at
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at