In a clinical trial of PUPs, 42.9% developed inhibitors.4,e
Novoeight® is designed for safety and purity.
Novoeight® has been shown to be safe and effective in pivotal trials.1
Novoeight® offers an established safety profile.
Results from guardian™1 and guardian™3 pivotal trials:a,b
- Safety results consistent among adults, adolescents, and children1,2
- No thromboembolic events occurred during the trials1,2
- The most frequently reported adverse reactions in previously treated patients were injection site reactions (2.3%), increased hepatic enzymes (1.4%),1,f and pyrexia (0.9%)4
- Adverse reactions reported during postmarketing period were similar to those observed during clinical trials.4
PUP=previously untreated patient
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, 2013.3
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
e59 PUPs with severe hemophilia A (factor VIII level ≤1%) received at least one dose of Novoeight® as part of either routine prophylaxis or on-demand treatment of bleeding episodes. Patients developed inhibitors with a mean of 14.1 exposure days at the time of the first positive inhibitor test. High risk genetic mutations were identified in 91.7% of the overall inhibitors and 93.3% of the high titer inhibitors.4
fAll patients who reported increased hepatic enzymes had hepatitis C at screening.1
Designed with purity in mind.
Novoeight® is manufactured without the addition of any human- or animal-derived protein in the cell culture process, purification, or final formulation.4,6,e It is the first recombinant FVIII to employ double nanofiltration as part of a 5-part purity process, which minimizes the risk of viral and protein contamination.7-9
Helps eliminate enveloped viruses
Uniquely selects intact molecules
Separates molecules from impurities, based on their charge
Removes small pathogens, reducing nonenveloped viruses
Reduces FVIII multimers
gProduced by recombinant DNA technology in Chinese hamster ovary cells.
What are the latest recommendations?
The National Hemophilia Foundation’s Medical and Scientific Advisory Council (MASAC) recommends recombinant products as a first-line therapy.10
Designed with molecular precision.
Novoeight® offers consistency from batch to batch.11,12
Dosing guidelines for Novoeight®.
Refer to our dosing tables for recommendations.
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