Jivi® safety and tolerability in previously treated adolescents and adults (main and long-term extension studies)1

DEMONSTRATED SAFETY PROFILE
FOR JIVI® IN THE MAIN STUDY

2/134 previously treated patients

Hypersensitivity reactions were transient (n=2/134)1

  • Allergic reactions occurred in two patients. In one patient the allergic reaction was related to polyethylene glycol (PEG), a component of Jivi2

Zero FVIII inhibitors1

  • No confirmed case of inhibitors against FVIII occurred1*

Four most common side
effects: headache, cough,
nausea and fever3

DEMONSTRATED SAFETY PROFILE FOR JIVI® IN A LONG-TERM EXTENSION STUDY3†

  • No FVIII inhibitors and no additional report of PEG-related clinical immune reactions4
  • No increasing plasma PEG levels over time5
  • Incidence of drug-related AEs and drug-related SAEs in safety population (N=121):4‡
    • Drug-related AEs: 5.0% (n=6)
    • Drug-related SAEs: 1.7% (n=2)
  • Factor VIII inhibitor (1.7 BU/mL) was reported in one previously treated adult subject. Repeat testing did not confirm the presence of a Factor VIII inhibitor.3
  • As of January 2015 interim analysis.6
  • Overall AEs: 80.2% (n=97).3
  • AE, adverse event; FVIII, Factor VIII; PEG, polyethylene glycol; SAE serious adverse effect.