ASH Clinical News June 2016 | Page 9

NOW AVAILABLE

Bayer continues more than 20 years of commitment
to the hemophilia A community with a new, unmodified,
full length rFVIII1
KOVALTRY® Antihemophilic Factor (Recombinant) is a recombinant human DNA sequence
derived, full length Factor VIII concentrate indicated for use in adults and children with
hemophilia A for:
On-demand treatment and control of bleeding episodes
Perioperative management of bleeding
Routine prophylaxis to reduce the frequency of
bleeding episodes
KOVALTRY® is not indicated for the treatment of
von Willebrand disease.

Explore this new treatment
at www.KOVALTRY.com

IMPORTANT SAFETY INFORMATION
KOVALTRY® is contraindicated in patients who have a history of hypersensitivity reactions to the active
substance, to any of the excipients, or to mouse or hamster proteins.
Hypersensitivity reactions, including anaphylaxis, are possible with KOVALTRY®. Early signs of
hypersensitivity reactions, which can progress to anaphylaxis, may include chest or throat tightness,
dizziness, mild hypotension and nausea. Discontinue KOVALTRY® if symptoms occur and seek
immediate emergency treatment.
KOVALTRY® may contain trace amounts of mouse and hamster proteins. Patients treated with this
product may develop hypersensitivity to these non-human mammalian proteins.
Neutralizing antibody (inhibitor) formation can occur following administration of KOVALTRY®.
Previously untreated patients (PUPs) are at greatest risk for inhibitor development with
all Factor VIII products. Carefully monitor patients for the development of Factor VIII
inhibitors, using appropriate clinical observations and laboratory tests. If expected
plasma Factor VIII activity levels are not attained or if bleeding is not controlled as
expected with administered dose, suspect the presence of an inhibitor.
Hemophilic patients with cardiovascular risk factors or diseases may be at the
same risk to develop cardiovascular events as non-hemophilic patients when
clotting has been normalized by treatment with Factor VIII.
Catheter-related infections may occur when KOVALTRY® is administered
via central venous access devices (CVADs). These infections have not
been associated with the product itself.
The most frequently reported adverse reactions in clinical trials
(≥3%) were headache, pyrexia, and pruritus.

For additional important risk and use information, please see brief summary
on the following pages.
You are encouraged to report negative side effects or quality complaints of prescription
drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
rFVIII=recombinant factor VIII.
Reference: 1. KOVALTRY® [prescribing information]. Whippany, NJ: Bayer HealthCare LLC; 2016.
Bayer, the Bayer Cross, and KOVALTRY are registered trademarks of Bayer.
© 2016 Bayer. All rights reserved.
Printed in USA 03/16 PP-675-US-0197