Why Jivi®?

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In a 36-week study of 132 patients with hemophilia A

Jivi® provided effective bleed protection1*

Study design

  • All (112) prophylaxis patients received 25 IU/kg twice weekly for 10 weeks before some were assigned and some were randomized to a treatment arm based on bleeding tendency1
  • Among patients with low bleeding tendencies, 11 received 30-40 IU/kg twice weekly and 43 patients received 45-60 IU/kg every 5 days, for 26 weeks1†
  • 13 patients with high bleeding tendencies received 30-40 IU/kg twice weekly for 26 weeks1‡
Of patients remained in these dosing groups through the end of the study1
  • ABR, annualized bleed rate (the number of bleeding events per year); IU, international units; kg, kilograms.
  • Median is the middlemost value of all reported values.
  • Mean is the sum of all reported values divided by the number of values reported.
  • n=11; n=13 (twice weekly: low; high).1
  • Patients were defined as having a low bleeding tendency if they had 0 or 1 spontaneous bleed (defined as a joint or muscle bleed and no identified trauma) during weeks 1-10 of the main study.1,2
  • Patients were defined as having a high bleeding tendency if they had 2 or more spontaneous bleeds (defined as joint or muscle bleeds and no identified trauma) during weeks 1-10 of the main study.1,2
  • Nine of the 13 patients in this group were on prior prophylaxis and had a mean number of 17.4 bleeds in the 12 months before the study.1
  • n=43 (every 5 days).1

Jivi® prophylaxis patients who experienced zero bleeds1

  • n=11; n=13 (twice weekly: low; high).1
  • Patients with 0 or 1 spontaneous bleed (defined as a joint or muscle bleed and no identified trauma) during weeks 1-10 of the main study.1,2
  • Patients with 2 or more spontaneous bleeds (defined as joint or muscle bleeds and no identified trauma) during weeks 1-10 of the main study.1,2
  • Patients with 0 bleeds during weeks 10-36 of the trial.1
  • n=43 (every 5 days).1

Jivi® provided effective treatment of bleeds1

of prophylaxis patients assessed treatment of bleeds as "Excellent" or "Good"
  • n=112 on prophylaxis.1
  • Treatment of bleeds from week 0 through week 36.1
  • Two patients stopped taking Jivi after a single dose of Jivi and were not included in these results.1
  • On a scale of: Excellent, Good, Moderate, Poor.1

Jivi® safety and tolerability were demonstrated in adolescents and adults1,2

In previously treated patients 12 years of age and older1:

Jivi is indicated for previously treated adolescents and adults aged 12 years and older with hemophilia A.1

  • A 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 (BU, Bethesda units; mL, milliliters).1
  • In at least 5% of patients.1

Jivi® is an extended-half-life rFVIII with unique step-wise dosing1-3

IU, international units; kg, kilograms; rFVIII, recombinant Factor VIII.
patients in the Jivi® study reduced their dosing frequency versus the pre-study prophylaxis regimen4*
  • 40/47 patients in the every-5-day and twice-weekly dosing arms for whom prior prophylaxis dosing records were available.4