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Novoeight® demonstrated effective, long-term prophylaxis by continuing to reduce bleeds.5,a
Novoeight®–proven reliability in treating bleeds.
Data from one of the largest clinical trial programs of a recombinant FVIII showed Novoeight® to be effective in adults, adolescents, and children. The guardian™ clinical trial program included 238 previously treated patients and more than 130,000 exposure days.1-3
Oscar lives with hemophilia A.
Proven effective in adults, adolescents, and children.
Median ABR
All patients
(0–65 years old)
median bleeds per year4,a
Children
(≤11 years old)
median bleeds per year2,b
Results of an initial clinical trial studying the effectiveness and safety in children
Long-term safety trial
median bleeds per year4,a
The majority of patients continued in a safety extension trial
ABR=annualized bleed rate.
Results from guardian™1 and guardian™3 pivotal trials1,2,6,b,c,d
Bleeds controlled with 1 or 2 infusions
Adolescents and adults
Aged 12-65 | N=150
Children
Aged 0-11 | N=63
Hemostatic success rate in major and minor surgeriesd
All patients
Bleeds controlled with 1 or 2 infusions
Adolescents and adults
Aged 12-65 | N=150
Children
Aged 0-11 | N=63
Hemostatic success rate in major and minor surgeriesd
All patients
aguardian™2: a phase 3b, non-randomized, open-label extension trial investigating the long-term safety and efficacy of turoctocog alfa in 213 previously treated males of all ages with severe hemophilia A. Of the 207 patients on prophylaxis, accumulated patient-years on prophylaxis was 730.8.5
bguardian™3: a multicenter, multinational, noncontrolled, open-label safety, efficacy, and pharmacokinetic trial in 63 previously treated pediatric patients (aged 0 to 11 years) with hemophilia A in which patients were exposed to turoctocog alfa for a mean of 60 exposure days (ranging from 20 to 104 exposure days).2
cguardian™1: a multicenter, multinational, open-label, single-arm efficacy and safety trial in 150 patients (aged 12 to 65 years) with severe hemophilia A on a prophylactic treatment regimen who were exposed to turoctocog alfa for a mean of 85 exposure days (ranging from 11 to 172 exposure days).1
dA hemostatic response rated as “excellent” or “good” was considered treatment success. If hemostatic response was rated as “moderate” or “none,” the treatment was considered treatment failure. Missing data were included in the treatment failure category.6
What About Safety?
The guardian™ clinical trial program also studied the safety of Novoeight®, an important consideration when choosing a treatment for your patients. The program included 238 previously treated patients (PTPs) and more than 130,000 exposure days.1-3
fPTPs who participated in the guardian 1, 2 and 3 clinical trials.1-3
Designed with molecular precision.
Novoeight® offers consistency from batch to batch.7,8
Dosing guidelines for Novoeight®.
Refer to our dosing tables for recommendations.
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