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: https://www.nice.org.uk/guidance/ta386. [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: https://www.scottishmedicines.org.uk/media/2277/ruxolitinib_JAKAVI_final.... [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.

Reduce MF splenomegaly and symptom burden with JAKAVI®

 

Help patients stay on track with flexible dosing

 

A manageable safety profile for your patients

 

How is MF treated in the real world?

 

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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 www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via uk.patientsafety@novartis.com or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at medinfo.uk@novartis.com