In a phase 3 study, Rebinyn® elevated factor levels above baseline levels, with +94% achieved after an infusion in adults2,b and 17% sustained after 7 days in adults, adolescents, and children.2,c
ACHIEVE HIGHER FACTOR ACTIVITY FOR LONGER

Rebinyn® helps your patients achieve higher factor levels that are sustained longer.1,a When compared with SHL and EHL products, Rebinyn® provides higher incremental recovery, longer half-life, and greater AUC.1-3,a


ACHIEVE HIGHER FACTOR ACTIVITY FOR LONGER

Rebinyn® helps your patients achieve higher factor levels that are sustained longer.1,a When compared with SHL and EHL products, Rebinyn® provides higher incremental recovery, longer half-life, and greater AUC.1-3,a


TAKE CONTROL WITH HIGH FACTOR ACTIVITY




With a single dose of Rebinyn® 40 IU/kg in adults with ≤2% factor levels2,c
aBased upon a phase 1 study of patients administered one of three doses of Rebinyn® (25, 50 or 100 IU/kg) compared with one 50 IU/kg dose of their prior SHL rFIX (n=7) or pdFIX (n=8) using a one-stage assay and product-specific standard. For Rebinyn®, estimated mean activity is adjusted to a dose of 50 IU/kg. Differences were similar in comparison of Rebinyn® to pdFIX (recovery 1.3 vs 1.1 IU/dL per IU/kg, 1.2x; half-life 93 vs 18 hours, 5.2x; AUC 70 vs 9 U x h/mL, 8x).
bBased upon a 2.34% increase in factor levels per IU/kg infused in adults.
cBased on pharmacokinetic assessment of a single dose of Rebinyn® 40 IU/kg in 6 adults (mean FIX activity 16.8%), 3 adolescents (mean FIX activity 14.6%), 13 children ages 7 to 12 (mean FIX activity 10.9%), and 12 children ages 0-6 (mean FIX activity 8.4%) upon enrollment in the phase 3 trials using one-stage assay and product-specific standard. All values are geometric mean.

achieved after an infusion2,b

sustained after 7 days2,c


With a single dose of Rebinyn® 40 IU/kg in adults with ≤2% factor levels2,c
aBased upon a phase 1 study of patients administered one of three doses of Rebinyn® (25, 50 or 100 IU/kg) compared with one 50 IU/kg dose of their prior SHL rFIX (n=7) or pdFIX (n=8) using a one-stage assay and product-specific standard. For Rebinyn®, estimated mean activity is adjusted to a dose of 50 IU/kg. Differences were similar in comparison of Rebinyn® to pdFIX (recovery 1.3 vs 1.1 IU/dL per IU/kg, 1.2x; half-life 93 vs 18 hours, 5.2x; AUC 70 vs 9 U x h/mL, 8x).
bBased upon a 2.34% increase in factor levels per IU/kg infused in adults.
cBased on pharmacokinetic assessment of a single dose of Rebinyn® 40 IU/kg in 6 adults (mean FIX activity 16.8%), 3 adolescents (mean FIX activity 14.6%), 13 children ages 7 to 12 (mean FIX activity 10.9%), and 12 children ages 0-6 (mean FIX activity 8.4%) upon enrollment in the phase 3 trials using one-stage assay and product-specific standard. All values are geometric mean.
In the phase 3 study, Rebinyn® achieved an 83-hour mean half-life in adults.2,c
COMPARATIVE PK DATA: REBINYN® VS SHL rFIX


In a study of previously treated adult patients, Rebinyn® was shown to increase FIX activity by 2 times, prolong time in the body by 5 times, and keep activity level higher by 10 times when compared with BeneFIX®, as illustrated below:
Comparison of Rebinyn® and BeneFIX:
Rebinyn® achieved and maintained higher factor activity1,a

The estimated time to 1% with Rebinyn® was 22.5 days.1,a
- Rebinyn® is not approved for routine prophylaxis.
- Animals given repeat doses of Rebinyn® showed accumulation of PEG in the choroid plexus. The potential clinical implications of these animal findings are unknown.
IN A PHASE 1 STUDY, COMPARED WITH BENEFIX, REBINYN® SHOWED1,a


2x
HIGHER RECOVERY1

5x
LONGER HALF-LIFE1

10x
GREATER AUC1

dPer IU/kg.
- Rebinyn® is not approved for routine prophylaxis.
- Animals given repeat doses of Rebinyn® showed accumulation of PEG in the choroid plexus. The potential clinical implications of these animal findings are unknown.
COMPARATIVE PK DATA: REBINYN® VS EHL FIX


In the paradigm™7 study, compared to Alprolix®, Rebinyn® was shown to increase FIX activity by 2 times, achieve 6 times higher factor activity at 7 days, and keep activity level higher by 4 times, as illustrated below:
Comparison of Rebinyn® and Alprolix:
Rebinyn® achieved and maintained higher factor activity3,e

eBased upon a phase 1 study of 15 patients administered a single dose of Rebinyn® 50 IU/kg compared with a single dose of Alprolix 50 IU/kg using both 1-stage (shown above) and chromogenic assays. The standard Alprolix dose of 50 IU/kg was administered for both products to allow for comparison of dose-dependent parameters; dose normalized to 50 IU/kg to reflect minor differences in dose administered. Geometric mean half-life was also prolonged (Rebinyn®: 103.2 hours, Alprolix: 84.9 hours). All comparisons were significant (P<0.0001) for all assays.3
The half-life of Rebinyn® was 103 hours vs 85 hours for Alprolix.3
- The clinical relevance of these PK differences is unknown
- Rebinyn® is not approved for routine prophylaxis
IN A PHASE 1 STUDY, COMPARED WITH ALPROLIX, REBINYN® SHOWED3,e


2x
HIGHER RECOVERY3

6x
FACTOR ACTIVITY AT 7 DAYS3

4x
GREATER AUC3

fPer IU/kg.
- The clinical relevance of these PK differences is unknown
- Rebinyn® is not approved for routine prophylaxis
COMPARE FIX TREATMENTS
See PK modeling data comparing Rebinyn® to SHL products for bleed control and target FIX levels in surgery.

COMPARE FIX TREATMENTS
See PK modeling data comparing Rebinyn® to SHL products for bleed control and target FIX levels in surgery.
EXTENDING HALF-LIFE

Rebinyn® stays in the body longer through PEGylation technology.4
SIMPLIFIED DOSING

Fixed dosing for all patients means no calculating desired factor IX activity levels.2
EXTENDING HALF-LIFE
Rebinyn® stays in the body longer through PEGylation technology.4
SIMPLIFIED DOSING
Fixed dosing for all patients means no calculating desired factor IX activity levels.2
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