Prescribing information

 

   

JAKAVI has a well-characterised safety and dosing profile, with manageable AEs1

The safety profile of JAKAVI® has been consistently demonstrated across 5-year follow-up to the COMFORT-I and COMFORT-II trials, and in real-world studies – with no newly observed patterns of AEs.1–5

Frequency category of adverse drug reactions reported in COMFORT-I and COMFORT-II1

Diagram showing the most commonly reported haematological and non-haematological AEs among patients who received JAKAVI in the COMFORT-I and COMFORT-II trials

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.2,6

Special warnings and precautions include myelosuppression, infections, progressive multifocal leukoencephalopathy and possible withdrawal effects. Please see the Summary of Product Characteristics for more details including possible drug interactions.

 

*Frequency is based on adverse event data.

  • A subject with multiple occurrences of an adverse drug reaction (ADR) is counted only once in that ADR category.
  • ADRs reported are on treatment or up to 28 days post treatment end date.

Frequency is based on all patients exposed to ruxolitinib in clinical studies (N=4755).

ADR derived from post-marketing experience.

§Frequency is based on laboratory values.

  • A subject with multiple occurrences of an ADR is counted only once in that ADR category.
  • ADRs reported are on treatment or up to 28 days post treatment end date.

Common Terminology Criteria for Adverse Events (CTCAE) version 3.0; grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening.

**Pancytopenia is defined as haemoglobin level <100 g/l, platelet count <100x109/l, and neutrophil count <1.5x109/l (or low white blood cell count of grade 2 if neutrophil count is missing), simultaneously in the same lab assessment.

 

 

ADR, adverse drug reaction; AE, adverse event; BAT, best available therapy; CTCAE, common terminology criteria for adverse events; MF, myelofibrosis.

References

  1. Novartis Pharmaceuticals UK Ltd. JAKAVI® summary of product characteristics.
  2. Harrison C, et al. N Engl J Med. 2012;366:787–798.
  3. Russell J, et al. Ruxolitinib in myelofibrosis: a multicentre experience from the east of England. EHA 2017, 22–25 June; Madrid, Spain. Abstract PB2057.
  4. Russell J, et al. Ruxolitinib in myelofibrosis: a multicentre experience in England, Northern Ireland and Wales. EHA 2018, 14–17 June; Stockholm, Sweden. Abstract PS1369.
  5. Verstovsek S, et al. J Hematol Oncol. 2017;10:55.
  6. Verstovsek S, et al. N Engl J Med. 2012;366:799–807.
UK | January 2021 | 103030
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Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at http://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]