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Home > Safety and Tolerability

JAKAVI has an established safety profile with a low discontinuation rate in clinical trials

Frequency category of adverse events with JAKAVI reported in the COMFORT studies[1]

Adverse events with Jakavi in the COMFORT studies table

Low discontinuation rates in patients with adverse events

  • Anaemia occurred in 83.8% of patients in the COMFORT studies but led to discontinuation in just 0.3% of patients[1]
  • Thrombocytopenia occurred in 80.5% of patients in the COMFORT studies but led to discontinuation in only 0.7% of patients[1]
  • Grades 3 and 4 incidences of anaemia and thrombocytopenia typically occurred within the first 6 months of treatment and decreased with long-term therapy[2]
ADR, adverse drug reaction; CTCAE, Common Terminology Criteria for Adverse Events; COMFORT, Controlled Myelofibrosis Study with Oral JAK Inhibitor Treatment; ULN, upper limit normal.
aFrequency is based on adverse event data. A subject with multiple occurrence 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.
bFrequency 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.
cPancytopenia 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.
dCommon Terminology Criteria for Adverse Events (CTCAE) version 3.0; grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening.
eThese ADRs are discussed in the text.
fFrequency is based on all patients exposed to ruxolitinib in clinical studies (N=4755).
gADR derived from post-marketing experience.

References

  1. JAKAVI® (ruxolitinib) tablets: EU Summary of Product Characteristics. Novartis; August 2021.

  2. Verstovsek S, Mesa RA, Gotlib J, et al. Efficacy, safety and survival with ruxolitinib in patients with myelofibrosis: results of a median 3-year follow-up of COMFORT-I. Haematologica. 2013;98(12):1865-1871.