A recombinant FVIII to prevent and control
bleeding in people with hemophilia A1
Novoeight®—designed to fit
into his world
Michael, 30 years old, lives with hemophilia A.
RELIABILIT Y
PURITY
POR TA B IL ITY
0
20
86 F
INHIBITORS
CONFIRMED1
One of the largest clinical trials with
no inhibitors confirmed in 213 PTPsa,b
UP TO
-NM FILTERS
4
Employs state-of-the-art
double nanofiltration
o
FOR 12
MONTHS1
Highest storage temperature
for the longest durationc
PTPs=previously treated patients.
Please see Prescribing Information for complete storage instructions.
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
b
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), which corresponds
to approximately 6 months in the trial. 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), which
corresponds to approximately 4.5 months in the trial. 3
c
Compared with other recombinant FVIII products.5-7
a
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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 concentrati ۋ