SELECTED IMPORTANT SAFETY INFORMATION:
You should not use Jivi if you are allergic to rodents (like mice and hamsters) or to any ingredients in Jivi. CONTINUE READING BELOW
SELECTED IMPORTANT SAFETY INFORMATION:
You should not use Jivi if you are allergic to rodents (like mice and hamsters) or to any ingredients in Jivi.
CONTINUE READING BELOW
The main clinical study and extension study of Jivi® were designed to reflect
real-world treatment4,6
Jivi dosing was tailored to patients' bleeding tendencies4
IU, international units; kg, kilograms.
*112 patients entered prophylactic treatment arms; an additional 20 patients entered a control arm of on-demand treatment. Two patients in the prophylactic arms left the study prematurely during the run-in period.1
†Defined as joint or muscle bleeds and no identified trauma.1,4
†112 patients entered prophylactic treatment arms; an additional 20 patients entered a control arm of on-demand treatment. Two patients in the prophylactic arms left the main study prematurely during the run-in period.1
§121 of 134 patients included in the main PROTECT VIII trial continued in the extension study, receiving either on demand treatment (n=14) or prophylaxis (n=107).8
¶Patients who switched dosing frequency at least once after the first week of the extension study were analyzed in a separate variable frequency group.8
Effective bleed protection with Jivi® in the main clinical study1
88.2% reduction in ABR versus on-demand treatment1
ABR, annualized bleed rate.
*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.1,4
‡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.1,4
§Nine of the 13 subjects in this group were on prior prophylaxis and observed to have a mean number of 17.4 bleeds in the 12 months prior to study entry.1
∥n=43 (every 5 days).1
ABRs assessed with Jivi® in the long-term extension study10
*As of 1/31/2018 cut off.10
‡Patients who switched dosing frequency at least once after the first week of the extension study were analyzed in a separate variable frequency group.6
ABR, annualized bleed rate.
Jivi® provided effective treatment of bleeds1
*n=112 on prophylaxis.1
†Treatment of bleeds from week 0 through week 36.1
‡Two patients discontinued after a single dose of Jivi and were not included in the efficacy analysis.1
Results from 82 patients who were in the prophylaxis group in the main study and who continued into the extension study.† (median time of 1421 days [range: 700-2071]8)
Analysis consisted of8:
Numbers of historic target joints recorded at study entry
Numbers of resolved target joints (≤2 spontaneous bleeds during the last 12 months)†
Analysis consisted of8:
Numbers of historic target joints, as judged by the investigator, recorded at study entry
Numbers of new target joints that developed on-study (≥3 spontaneous bleeds within 6 months)†
Numbers of resolved target joints (≤2 spontaneous bleeds during the last 12 months)†
*Patients remaining on the same prophylaxis regimen during the last 90 days of treatment. Median joint ABRs were 0.00 for twice-weekly and 0.00 for every-5-day dosing interval.9
†As defined by the International Society of Thrombosis and Hemostasis (ISTH).8
Long-term safety data with Jivi® in adolescents and adults1,2,4
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
‡As of January 2018 interim analysis.4,6
Are you sure you want to leave the Jivi website?
Bayer is not responsible for the content viewed on other websites.