Is it time to reconsider your treatment
for hemophilia A?
Novoeight ® —designed to support
an active lifestyle
0
225
inhibitors confirmed b,c
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A
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HALF-LIF
One of the largest clinical trials
with no inhibitors confi rmed
in
previously treated
patients b,d
receiving
c
a
Based
on on
data
for for
Q2 Q2
2015-Q1
2016;
accounts
for net
and and
losses of patients
Based
data
2015-Q1
2016;
accounts
for gains
net gains
switching
to patients
and from switching
standard to
half-life
rFVIII standard
available half-life
for at least
1 year. 1
losses of
and from
rFVIII
available
for at
one Nordisk
year. Inc; Plainsboro, NJ.
Reference:
1. Data
on least
file. Novo
1
88,000
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Novoeight ® offers reliability.
infusions b,c
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to learn more.
Please see Prescribing Information for complete storage instructions.
guardian ™ 1: a multicenter, multinational, open-label, single-arm effi cacy 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, effi cacy, 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
c
guardian ™ 2: a prospective, open-label, uncontrolled extension trial investigating the safety and effi cacy 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
d
Patients with previous inhibitors were excluded from the trials. Individuals with hemophilia A may develop inhibitors to FVIII. Monitor patients taking Novoeight ® for inhibitor formation. 5
b
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 enzymes, and pyrexia.
Please see B