Annals of Hematology

, Volume 97, Issue 5, pp 913–914 | Cite as

Infections associated with ruxolitinib: study in the French Pharmacovigilance database

  • Pinel SylvineEmail author
  • Sternjacob Thomas
  • Eftekhari Pirayeh
  • The French Network of Regional Pharmacovigilance Centers
Letter to the Editor

Dear Editor,

Ruxolitinib, an orally bioavailable potent and selective inhibitor of Janus kinases (JAKs) 1 and 2, has been approved in Europe for the treatment of myelofibrosis and polycythemia vera.

Ruxolitinib improves disease-related constitutional symptoms, splenomegaly and overall survival in myelofibrosis. However, studies suggest that the drug exerts immunosuppressive activity and may predispose patients to infections [1].

Here, we report all the infectious adverse events (I-AEs) registered in the French Pharmacovigilance database between August 23, 2012 and August 31, 2017 with ruxolitinib as “suspect” or “interacting drug” and adverse drug reactions (ADRs) coded as “infections and infestations” with MedDRA System Organ Class (SOC).

The French Pharmacovigilance database was established in 1985 to record spontaneous reporting of adverse drug reactions reported to the network of 31 French Regional Pharmacovigilance Centers.

In this retrospective study, based on spontaneous...


Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.


  1. 1.
    Yang LPH, Keating KM (2012) Ruxolitinib: In the Treatment of Myelofibrosis. Drugs 72 (16):2117–2127Google Scholar
  2. 2.
    Saeed I, McLornan D, Harrison CN (2017) Managing side effects of JAK inhibitors for myelofibrosis in clinical practice. Expert Rev Hematol 10(7):617–625Google Scholar
  3. 3.
    Abidi MZ, Haque J, Varma P and al (2016) Reactivation of pulmonary tuberculosis following treatment of myelofibrosis with ruxolitinib. Case Rep Hematol Article ID 2389038Google Scholar
  4. 4.
    Malkan UY, Haznedaroglu IC (2017) A myelofibrosis case that develops mycobacterial infection after ruxolitinib treatment (case report). Int J Clin Exp Med 10(4):7304–7307Google Scholar
  5. 5.
    Pálmason R, Lindén O, Richter J (2015) EBV driven lymphoproliferative disorder associated with ruxolitinib (case-report). BMC Hematol 15:10Google Scholar
  6. 6.
    Cen CC, Chen YY, Huang CE (2016) Cryptococcal meningoencephalitis associated with the long-term use of ruxolitinib. Ann Hematol 95:361–362Google Scholar
  7. 7.
    Kusano Y, Terui Y, Ueda K and al (2016) Klebsiella pneumoniae primary liver abscess associated withruxolitinib Ann Hematol 95:1561–1562Google Scholar
  8. 8.
    Shen CH, Hwang CE, Chen YY and al (2014) Hepatitis B virus reactivation associated with ruxolitinib. Ann Hematol 93:1075–1076Google Scholar
  9. 9.
    Manduzio P (2017) Ruxolitinib in myelofibrosis: to be or not to be an immune disruptor. Ther Clin Risk Manag 13:169–177Google Scholar
  10. 10.
    Schönberg K, Rudolph J, Vonnahme M and al (2015) JAK Inhibition Impairs NK Cell Function in Myeloproliferative Neoplasms. Cancer Res 75(11):2187–2199Google Scholar

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  1. 1.French Regional Pharmacovigilance CenterFernand-Widal Hospital - APHPParisFrance

Personalised recommendations