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  3. When to use JAKAVI® (ruxolitinib)

Prescribing information

 

When to use JAKAVI® (ruxolitinib)

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Use Jakavi as soon as patients are eligible to bring the most benefit to their lives1–4

 

Patients with MF face increasingly debilitating symptoms as the disease progresses, with symptoms that negatively affect QoL.5,6

JAKAVI can change lives in MF by offering patients rapid and durable improvements in MF-related symptoms and splenomegaly, regardless of MF risk status.7,8

 

Using JAKAVI early may increase benefits for eligible patients with MF, helping to improve their symptom burden so they can get back to being more like themselves9,10

 

Diagram showing results with JAKAVI in patients with high disease burden

An ad-hoc analysis of JUMP§ showed that low-risk patients achieved slightly greater spleen size reductions vs high-risk patients, suggesting that earlier JAKAVI treatment may lead to greater benefits in patients with myelofibrosis.10

Proactively monitor all your patients’ MF-related symptoms to treat as early as possible those who can benefit from JAKAVI.1–4

 

JUMP was a Phase 3b expanded access trial (N=2233) assessing the efficacy and safety of JAKAVI in patients with intermediate- or high-risk MF (n=1114), intermediate-1-risk MF (n=163) and low-risk MF (n=60). Primary endpoint was assessment of JAKAVI tolerability by the frequency, duration and severity of AEs.10,11

* Data from a retrospective analysis of 408 patients with MF treated with JAKAVI.9
† OR=0.25, 95% CI (0.13–0.47), p<0.001.9
‡ A symptom response is defined as a ≥50% reduction in the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS).9

§ Data from an ad-hoc analysis of the safety and efficacy of JAKAVI in a subset of patients in JUMP with DIPSS low-risk MF (n=60).10

Abbreviations

AE, adverse event; CI, confidence interval; DIPSS, dynamic international prognostic scoring system; JUMP, JAK Inhibitor Ruxolitinib in Myelofibrosis Patients; MF, myelofibrosis; OR, odds ratio; QoL, quality of life; TSS, Total Symptom Score

References

  1. Reilly J, et al. Br J Haematol. 2014;167:418–438.
  2. 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 2020.
  3. 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 April 2020.
  4. Mesa R, et al. Blood. 2012;120:Abstract 1727.
  5. Mesa R, et al. BMC Cancer. 2016;16:167.
  6. Vannucchi A, et al. Haematologica. 2015;100:1139–1145.
  7. Novartis Pharmaceuticals UK Ltd. JAKAVI® summary of product characteristics. 
  8. Vannuchi A and Harrison C. Blood. 2017;129:693–703. 
  9. Palandri F, et al. Oncotarget. 2017;8:79073–79086.
  10. Guglielmelli P, et al. EHA 2018, 14–17 June; Stockholm, Sweden. Poster PF623.
  11. Al-Ali H, et al. Haematologica. 2016;101:1065–1073. 

 

 

 

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HCP20-C024a June 2020.
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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 [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
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