ASH Clinical News ACN_4.12_SUPP_web | Page 2

In hemophilia B
TAKE CONTROL
TO A
HIGH
LEVEL
WITH REBINYN ®
Rebinyn ® elevates factor levels above baseline levels 1,a
+ 94 %
17 %
FIX levels
achieved
immediately after an infusion 1,b
Based upon a 2.34% increase in factor levels per
IU/kg infused in adults.
b
FIX levels
sustained
after 7 days 1,a
Based on a single initial dose of Rebinyn ® 40 IU/kg
in 6 adults (mean FIX activity 16.8%), 3 adolescents
(mean FIX activity 14.6%), 13 children ages 7 to 12
(mean FIX activity 10.9%), and 12 children ages
0-6 (mean FIX activity 8.4%) upon enrollment in
the phase 3 trials using one-stage assay with
product-specific standard.
a
With a single dose of Rebinyn ® 40 IU/kg
in adults with ≤2% factor levels 1,a
Clayton, 34 years old, is a pilot who hikes and camps
in his spare time. Clayton lives with hemophilia B.
Image of hemophilia B patient shown is for illustrative purposes only.
INDICATIONS AND USAGE
Rebinyn ® , Coagulation Factor IX (Recombinant),
GlycoPEGylated, is a recombinant DNA derived coagulation
Factor IX concentrate indicated for use in adults and
children with hemophilia B for on demand treatment
and control of bleeding episodes and perioperative
management of bleeding.
Limitations of Use: Rebinyn ® is not indicated for routine
prophylaxis or for immune tolerance induction in patients
with hemophilia B.
IMPORTANT SAFETY INFORMATION
Contraindications
• Rebinyn ® is contraindicated in patients with a known
hypersensitivity to Rebinyn ® or its components, including
hamster proteins.
Warnings and Precautions
• Hypersensitivity reactions, including anaphylaxis, may
occur. Signs may include angioedema, chest tightness,
difficulty breathing, wheezing, urticaria, and itching.
Discontinue Rebinyn ® if allergic or anaphylactic-type
reactions occur and initiate appropriate treatment.
• Development of neutralizing antibodies (inhibitors) to
Factor IX may occur. Monitor patients for development of
factor IX inhibitors if bleeding is not controlled with the
recommended dose of Rebinyn ® or if expected Factor IX
activity plasma levels are not attained. Factor IX activity
assay results may vary with the type of activated partial
thromboplastin time reagent used.
• The use of Factor IX-containing products has been
associated with thrombotic complications. Monitor
for thrombotic and consumptive coagulopathy when
administering Rebinyn ® to patients with liver disease,
post-operatively, to newborn infants, or to patients at risk of
thrombosis or disseminated intravascular coagulation (DIC).
• Nephrotic syndrome has been reported following
immune tolerance induction therapy with Factor IX
products in hemophilia B patients with Factor IX
inhibitors, often with a history of allergic reactions to
Factor IX. The safety and efficacy of using Rebinyn ® for
immune tolerance induction have not been established.
Adverse Reactions
• The most common adverse reactions reported in clinical
trials (≥1%) were itching and injection site reactions.
• Animals administered repeat doses of Rebinyn ® showed
accumulation of PEG in the choroid plexus. The potential
clinical implications of these animal findings are unknown.
Please see Brief Summary of Prescribing Information on
the following page.
Reference: 1. Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2017.
Learn more at rebinynpro.com
Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, New Jersey 08536 U.S.A.
Rebinyn ® is a registered trademark of Novo Nordisk Health Care AG.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2018 Novo Nordisk
All rights reserved. USA18BIO00598 August 2018