Jivi®: Powerful protection from bleeds with a twice-weekly starting dose and the potential to step up to every 5 days and fine tune2
Jivi is indicated for previously treated patients aged ≥12 years.2
Explore data below on Kogenate® FS patients who transitioned to Jivi as part of a clinical trial.
Jivi Prophylaxis Treatment
Proven efficacy and safety in adults and adolescents (12 years of age and older) who participated in the Jivi Clinical Study (n=112)#
Study design
110 prophylaxis patients completed a 10-week run-in period where they received 25 IU/kg twice weekly. They were then assigned or randomized to a treatment arm based on bleeding tendency (low or high). 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 weeks, 13 patients with high bleeding tendencies received 30-40 IU/kg twice weekly for 26 weeks.2§
| TOTAL ABR | SPONTANEOUS ABR | ||||
|---|---|---|---|---|---|
| Bleeding Tendency2 | Median | Mean | Median | Mean | |
| TWICE WEEKLY2 | LOW*¶ | 1.9 | 2.2 | 0 | 1.2 |
| HIGH†¶ | 4.1 | 7.2 Reduced from 17.4 ABR2 | 3.9 | 3.9 | |
| EVERY 5 DAYS2 | LOW*¶ | 1.9 | 3.3 | 0 | 1.8 |
| COMBINED (n=67)2 | 2.1 | 3.9 | |||
inhibitors2 in the completed study*5
‡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.2
- The common side effects of Jivi are headache, cough, nausea, and fever.
- Allergic reactions occurred in 2 patients. In 1 patient, the allergic reaction was related to polyethylene glycol (PEG), a component of Jivi.
ABR, annualized bleed rate.
*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.3
†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.3
‡June 2014 data cutoff.
§n=9/13 of these patients were on prior prophylaxis and had a mean number total ABR of 17.4 before entering the main study.3
¶n=11; n=13 (twice weekly: low; high).2
#112 patients entered prophylactic treatment arms. Two patients enrolled in the prophylactic arms left the main study prematurely during the run-in period.
21 adolescent and adult Kogenate FS patients (12 years of age or older) transitioned to Jivi prophylaxis as part of the 26 week Jivi Clinical study. In an analysis of study data completed after the study ended, it was determined that Kogenate FS patients who transitioned to Jivi experienced:
A reduction in ABR*
inhibitors6
| MEDIAN ABR6 | MEAN ABR6 | |
|---|---|---|
| Kogenate® FS ABR prior to study enrollment | 9 | 10.5 |
| Jivi® ABR during study | 2.1 | 5.2 |
~67% of patients previously on Kogenate FS were on an every-5-day Jivi regimen in the study
A drug-related adverse event was reported in one patient. There were no serious drug related adverse events.
ABR, annualized bleed rate.
*Self-reported bleeds in prior 12 months.6
§June 2014 data cutoff.
| FOR PATIENTS ≥ 12 YEARS | ||
|---|---|---|
| Start Simply |
TWICE
WEEKLY |
For all prophylaxis patients: Recommended starting regimen is Jivi twice weekly (30-40 IU/kg)2 |
| Step Up |
EVERY
5 DAYS |
Based on bleeding episodes: Less frequent dosing of Jivi every 5 days (45-60 IU/kg) can be used2 |
| Fine Tune |
 |
Based on bleeding episodes: The dosing frequency may be further adjusted up or down2 |
2.2 lbs. = 1 kgs
Jivi offers prophylaxis adolescent and adult patients currently on Kogenate FS...
- Powerful protection from bleeds with a twice-weekly starting dose and the potential to step up to every 5 days and fine tune2
- A demonstrated safety profile in previously-treated adolescents and adults4,6
- The potential for fewer infusions5
- 8/10 patients in the Jivi clinical study reduced their dosing frequency vs. their pre-study prophylaxis regimen
In a study analysis, prophylaxis patients who transitioned to Jivi from Kogenate FS experienced:6
A reduction in bleeds per year (ABR)*
inhibitors
~67% of patients previously on Kogenate FS were on an every 5-day Jivi regimen in the study
The common side effects of Jivi are headache, cough, nausea, and fever.
ABR, annualized bleed rate.
*Self-reported bleeds in prior 12 months.6
Click here to download Jivi prophylaxis data
Jivi On-Demand Treatment
Jivi Clinical Study (20 patients)
The safety and efficacy of Jivi for on-demand treatment in adolescent and adult (12 to 65 years of age) previously treated patients (PTPs) was evaluated for 36 weeks.2,7
On-demand clinical study data Circle
91.2%
of bleeds were treated
with ≤2 infusions7
40.4% of total bleeds were trauma bleeds.7
79.5%
1 infusion7
11.7%
2 infusions7
8.8%
3+ infusions7
inhibitors
in the main study analysis of 20 previously treated patients.7
One patient in the on-demand group (n=20) experienced mild drug-related adverse events (dry mouth, musculoskeletal discomfort).7
The on-demand arm in the Jivi clinical study and the subgroup analysis both included patients with Hepatitis B, Hepatitis C, and HIV.8
10 Kogenate FS on-demand patients transitioned to Jivi on-demand as part of the clinical study.7
In an analysis of the clinical study data completed after the study ended, it was determined that in Kogenate FS patients who transitioned to Jivi:
Kogenate FS on-demand patients who transitioned to Jivi
90.6%
of bleeds were treated
with ≤2 infusions7
36.0% of total bleeds were trauma bleeds.7
73.9%
1 infusion7
16.7%
2 infusions7
9.4%
3+ infusions7
inhibitors
in the subgroup analysis of 10 previously treated patients.7
One patient in the on-demand subgroup (n=10) experienced mild drug-related adverse events (dry mouth, musculoskeletal discomfort).8
The on-demand arm in the Jivi clinical study and the subgroup analysis both included patients with Hepatitis B, Hepatitis C, and HIV.8
Jivi offers on-demand adolescent and adult patients currently on Kogenate FS...
- Effective treatment of bleeds4,6
- A proven safety profile4,6
In a study analysis, on-demand patients who transitioned to Jivi from Kogenate FS experienced:7
90.6%
of bleeds treated with ≤2 infusions
inhibitors
The common side effects of Jivi are headache, cough, nausea, and fever.
Click here to download Jivi on-demand data
For more information about Jivi, including data from the Jivi extension study and details on Jivi's PK coverage, visit www.ExploreJivi.com.
1. Kogenate Prescribing Information. Bayer HealthCare LLC, Whippany, NJ. 2. Jivi Prescribing Information. Bayer HealthCare LLC, Whippany, NJ; 2018. 3. Reding MT et al. J Thromb Haemost 2017; 15:411-419. 4. Lalezari S et al. Haemophilia 2019;25:1011-1019. 14. Data on file. Tx Review 0918, Bayer; 2018. 5. Kerlin BA et al. Poster P153. Presented at the 4th Biennial Summit of the Thrombosis & Haemostasis Societies of North America. March 8-10, 2018, San Diego, California. 6. Data on file. Jivi Protect VIII Subgroup Analysis. Bayer HealthCare LLC, Whippany, NJ. 7. Data on file. Protect VIII (13024) prior OD Kogenate FS/Helixate FS Cohort Descriptive Analysis. Bayer Healthcare LLC, Whippany, NJ. 8. Data on file. Jivi Protect FVIII (13024) Subgroup- prior Kogenate FS/Helixate FS Cohort. Bayer Healthcare LLC, Whippany, NJ.
