A recombinant FVIII to prevent and control bleeding in people with hemophilia A1
Novoeight®—designed
to fit into their world
RELIA BIL IT Y
0
INHIBITORS CONFIRMED1
One of the largest clinical trials with no inhibitors
confirmed in 213 previously treated patientsa,b
PU RITY
20
-NM FILTERS4
Employs state-of-the-art double nanofiltration
POR TA B IL IT Y
UP TO
David, 22 years old,
lives with hemophilia A
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today to learn more.
86 F
o
FOR 12 MONTHS1
Highest storage temperature for the longest durationc
Please see Prescribing Information for complete storage instructions.
a
Patients with previous inhibitors were excluded from the trial. Individuals with hemophilia A may develop inhibitors to FVIII. Monitor patients taking Novoeight ® for inhibitor formation.1
guardian™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). 2 guardian™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). 3
b
c
Compared with other recombinant FVIII products.5-7
Indications and Usage
Novoeight® (Antihemophilic Factor [Recombinant]) is indicated for use in adults and children with hemophilia A for control and prevention
of bleeding, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
Novoeight® is not indicated for the treatment of von Willebrand disease.
Important Safety Information
Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight® or its components,
including hamster proteins.
Anaphylaxis and severe hypersensitivity reactions are possible. Patients may develop hypersensitivity to hamster proteins, which are present
in trace amounts in the product. Should symptoms occur, discontinue Novoeight® and administer appropriate treatment.
Development of activity-neutralizing antibodies (inhibitors) may occur. If expected plasma factor VIII activity levels are not attained,
or if bleeding is not controlled with an appropriate dose, perform an assay that measures factor VIII inhibitor concentration.
The most frequently reported adverse reactions (≥0.5%) were injection site reactions, increased hepatic