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Prescribing information

 

Optimising JAKAVI® (ruxolitinib) dosing

   

JAKAVI is available in four tablet strengths to enable dose optimisation for each patient1

The recommended starting dose for JAKAVI is based on a patient’s platelet count at treatment initiation.1

  • 15 mg twice daily for patients with a platelet count between 100,000/mm3 and 200,000/mm3
  • 20 mg twice daily for patients with a platelet count of >200,000/mm3

The maximum recommended starting dose in patients with platelet counts between 50,000/mm3 and <100,000/mm3 is 5 mg twice daily and patients should be titrated cautiously.1

Image showing the four available tablet strengths for JAKAVI: 5 mg, 10 mg, 15 mg and 20 mg
 
Tablets shown are not actual size          
 

To optimise treatment efficacy with JAKAVI, patients should be maintained at their highest recommended tolerated dose1–3

Graph showing mean spleen volume reduction by dose of JAKAVI from baseline to Week 48 in COMFORT-I

 

 

Treatment may continue as long as benefit-risk balance remains positive. After interruption or discontinuation of JAKAVI dosing, symptoms of myelofibrosis may return over a period of approximately 1 week. Unless abrupt discontinuation is required, gradual tapering of the dose may be considered, although the utility of tapering is often unproven. Refer to the full Product Information in the Summary of Product Characteristics. for further management guidance.

 

Similar findings have also been observed in a real-world setting, with patients treated with doses 10 mg BID having better spleen response rates (44.4% vs 25.4% in patients treated with 10 mg BID, p=0.01).†2

Graph showing mean spleen volume reduction with JAKAVI from baseline to Week 48 in COMFORT-I

 

COMFORT-I (double blind) and COMFORT-II (open label) were randomised, Phase 3 studies of JAKAVI vs placebo and BAT, respectively (COMFORT-I, n=155 and n=154 for JAKAVI and placebo, respectively; COMFORT-II, n=146 and n=73 for JAKAVI and BAT, respectively). Primary endpoint: proportion of patients achieving a ≥35% reduction in spleen volume from baseline at Week 24 and Week 48, respectively.4,5

* Grade 3 or 4 thrombocytopenia is defined as absolute platelet counts below 50,000/mm3.
† p values are descriptive only.

BAT, best available therapy; BID, twice daily; MF, myelofibrosis.

References

  1. Novartis Pharmaceuticals UK Ltd. JAKAVI® summary of product characteristics.
  2. Polverelli N, et al. EHA 2016, 14–17 June; Copenhagen, Denmark. Abstract P672.
  3. Verstovsek S, et al. Haematologica. 2013;98:1865–1871.
  4. Harrison C, et al. N Engl J Med. 2012;366:787–798.
  5. Verstovsek S, et al. N Engl J Med. 2012;366:799–807.
  6. Cervantes F. Blood. 2014;124:2635–2642.
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HCP20-C024d May 2020.
Haematology
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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
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]