Prescribing information

 

For your myelofibrosis patients with 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

Box 1: BSH logo with text Recommended by BSH guidelines and reimbursed across the UK;
Box 2: Spleen icon with the text Treating with Jakavi can help reduce a patient's spleen size and symptom burden;
 
Box 3: checkmark icon with text Well-charaacterised safety profile;
Box 4: Medicine icon with the text Improved survival benefit compared with BAT.
 

 

JAKAVI® is the first JAK inhibitor approved for the treatment of MF, with 150,000 years of patient experience§8,9

* Patients treated with JAKAVI® achieved reduction in spleen length at Week 4, confirmed by reduction in spleen volume at Week 24, which was maintained to Week 48, and improvement in symptoms at Week 4, maintained to Week 24. The median time to 1st CT/MRI observation of a ≥35% reduction in spleen size was 12.3 weeks.5,6
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 confirmed by MRI or CT showing ≥35%.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 2020.9

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. Reilly J, et al. Br J Haematol. 2014;167:418–438.
  3. 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. Last accessed April 2021.
  4. 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.... Last accessed May 2021.
  5. Verstovsek S, et al. N Engl J Med. 2012;366:799–807.
  6. Harrison C, et al. N Engl J Med. 2012;366:787–798.
  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, 2020).
  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 | May 2021 | 119284
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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