Prescribing information

 

For your eligible myelofibrosis patients with disease-related splenomegaly or symptoms1-7

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

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Recommended by BSH guidelines and reimbursed across the UK2,9,10

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Treating with JAKAVI® can help reduce a patient's spleen size vs BAT and symptom burden vs placebo*†7,8

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Long-term treatment with JAKAVI® prolonged survival vs control.11

 

In an analysis of 5-year pooled data from the COMFORT studies, the risk of death (exploratory endpoint) was reduced by 30% in patients randomised to JAKAVI® vs control (placebo in COMFORT-I, BAT in COMFORT-II); median OS (JAKAVI® vs control), 5.3 vs 3.8 years (HR, 0.70; 95% CI, 0.54–0.91; P=0.0065)11

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Well-characterised safety profile1

JAKAVI® is the only JAK inhibitor approved for MF with up to 5 years follow-up data‡1,7,12

*Comfort 1: 41.9% of patients in the JAKAVI® group achieved a reduction in spleen volume of 35% or more at 24 Weeks (primary endpoint) vs with 0.7% in the placebo group (p<0.001). The proportion of patients with a reduction of 50% or more in the total symptom score from baseline to Week 24, a prespecified secondary endpoint, was significantly higher in the JAKAVI® group than in the placebo group (45.9% vs. 5.3%; odds ratio, 15.3; 95% CI, 6.9 to 33.7; p<0.001). Comfort 2: 28% of the patients in the JAKAVI® group achieved at least a 35% reduction in spleen volume at Week 48 (primary endpoint) compared with 0% in the group receiving BAT (p<0.001). In prespecified exploratory analyses of patient reported outcomes (as assessed by means of the EORTC QLQ-C30 and FACT-Lym subscales), improvements in quality-of-life and role functioning scores were observed in patients who received JAKAVI®, compared to patients who received BAT; no statistical analyses were conducted. At Week 48, patients receiving JAKAVI® had marked reductions in myelofibrosis-associated symptoms, including appetite loss, dyspnea, fatigue, insomnia and pain, whereas patients receiving the best available therapy had worsening symptoms.7,8
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.13
As of February 22nd 2021.14

BAT, best available therapy; BSH, British Society for Haematology; CI, confidence interval; COMFORT, Controlled Myelofibrosis Study with Oral JAK Inhibitor Treatment; CT, computed tomography; EORTC QLQ-C30, European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire; FACT-Lym, The Functional Assessment of Cancer Therapy-Lymphoma; HR, hazard ratio; JAK, janus kinase; MF, myelofibrosis; MRI, magnetic resonance imaging; OS, overall survival.

  1. Novartis Pharmaceuticals UK Ltd. JAKAVI® summary of product characteristics.
  2. Scottish Medicines Consortium. Ruxolitinib (Jakavi®). Available at: https://www.scottishmedicines.org.uk/medicines-advice/ruxolitinib-jakavi.... [Accessed October 2023].
  3. Vannucchi AM, et al. N Engl J Med 2015;372:426–435.
  4. Verstovsek S, et al. Haematologica 2016;101:821–829.
  5. Griesshammer M, et al. Ann Hematol 2018;97:1591–1600.
  6. Griesshammer M, et al. Ann Hematol 2018;97:1591–1600. Supplementary appendix.
  7. Verstovsek S, et al. N Engl J Med 2012;366:799–807.
  8. Harrison C, et al. N Engl J Med 2012;366:787–798.
  9. Reilly J, et al. Br J Haematol 2014;167:418–438.
  10. 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 October 2023].
  11. Verstovsek S, et al. J Hematol Oncol 2017;10:156.
  12. Harrison C, et al. Leukemia 2016;30:1701–1707.
  13. Polverelli N, et al. EHA 2016, 9–12 June; Copenhagen, Denmark. Poster P672.
  14. Bose, P and Verstovsek S. Hemasphere 2020;4(4):e424. 

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UK | October 2023 | 309534

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 [email protected] or online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]