ASH Clinical News December 2016 | Page 87

Is it time to reconsider your treatment
for hemophilia A?
Novoeight®—designed to support
an active lifestyle

0
225

inhibitors confirmedb,c

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One of the largest clinical trials
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in

previously treated
patientsb,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
topatients
and fromswitching
standard to
half-life
rFVIIIstandard
available half-life
for at least
1 year.1
losses of
and from
rFVIII

available
for at
oneNordisk
year. Inc; Plainsboro, NJ.
Reference:
1. Data
on least
file. Novo
1

88,000

Whether planning a trip or being active at home,
Novoeight® offers reliability.

infusionsb,c

Visit NovoeightPro.com today
to learn more.

Please see Prescribing Information for complete storage instructions.
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
c
guardian™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
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 Brief Summary of Prescribing Information on following page.
References: 1. Data on file. Novo Nordisk Inc; Plainsboro, NJ. 2. Lentz SR, Misgav M, Ozelo M, et al. Results from a large multinational clinical trial (guardian™1) using prophylactic treatment with turoctocog alfa in
adolescent and adult patients with severe haemophilia A: safety and efficacy. Haemophilia. 2013;19(5):691-697. 3. Kulkarni R, Karim FA, Glamocanin S, et al. Results from a large multinational clinical trial (guardian™3)
using prophylactic treatment with turoctocog alfa in paediatric patients with severe haemophilia A: safety, efficacy and pharmacokinetics. Haemophilia. 2013;19(5):698-705. 4. Lentz SR, Cerqueira M, Janic D, et al.
Interim results from a large multinational extension trial (guardian™ 2) using turoctocog alfa for prophylaxis and treatment of bleeding in patients with severe haemophilia A. Haemophilia. 2016;22(5):1-5. 5. Novoeight
[package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2015.

Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, New Jersey 08536 U.S.A.
Novoeight® is a registered trademark of Novo Nordisk Health Care AG.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2016 Novo Nordisk
All rights reserved.
USA16HDM01372
November 2016