Novoeight® demonstrated effective, long-term prophylaxis by continuing to reduce bleeds.5
Novoeight®–proven reliability in treating bleeds.
Data from one of the largest clinical trial programs of a recombinant FVIII to date showed Novoeight® to be effective in adults, adolescents, and children. The guardian™ Clinical Trial program included 242 previously treated patients receiving over 119,000 infusions.1-4, a-d
Oscar lives with hemophilia A.
Proven effective in adults, adolescents, and children.
Median ABR
All patients
(0–65 years old)
In initial clinical trials, previously treated patients who took Novoeight® had a median of 3.7 bleeds per year.4
Children
(≤11 years old)
In an initial clinical trial, previously treated children who took Novoeight® had a median of 3.0 bleeds per year.2
Safety extension trial
The majority of patients continued in a safety extension trial. Final results and analysis showed that patients had a median of 1.4 bleeds per year.5,c
ABR=annualized bleed rate.
Results from guardian™1 and guardian™3 pivotal trials
Bleeds controlled with 1 or 2 infusions1,2,a,b
Adolescents and adults
Aged 12-65 | N=150
Children
Aged 0-11 | N=63
Hemostatic success rate in major and minor surgeries6,e
All patients
Bleeds controlled with 1 or 2 infusions1,2, a,b
Adolescents and adults
Aged 12-65 | N=150
Children
Aged 0-11 | N=63
Hemostatic success rate in major and minor surgeries5,e
All patients
aguardian™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
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™2: a prospective, open-label, uncontrolled extension trial investigating the safety and efficacy of turoctocog alfa in 55 pediatric, 23 adolescent, and 122 adult patients with severe hemophilia A for a mean of 361.6 exposure days. The data cutoff date was December 31, 2013.4-5
dPatients with previous inhibitors were excluded from the trials. Individuals with hemophilia A may develop inhibitors to FVIII. Monitor patients taking Novoeight® for inhibitor formation.4
eA 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 guardian™ Clinical Trial program included 242 previously treated patients receiving over 119,000 infusions.1-4,a-d
Designed with molecular precision.
Novoeight® offers consistency from batch to batch.8,9
Dosing guidelines for Novoeight®.
Refer to our dosing tables for recommendations.
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