Recently, I had a shoulder
bleed. So, I got out my
NovoSeven® RT ...
... minutes later, it’s in
my system. Later, the
bleed in my shoulder
was controlled.
—Bob
BOB
Bob has congenital hemophilia with inhibitors
Individual results may vary.
Indications and Usage
Warnings and Precautions
NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) is a
coagulation factor indicated for:
• Serious arterial and venous thrombotic events have been reported
in clinical trials and postmarketing surveillance.
• Treatment of bleeding episodes and peri-operative management in
adults and children with hemophilia A or B with inhibitors, congenital
Factor VII (FVII) deficiency, and Glanzmann’s thrombasthenia with
refractoriness to platelet transfusions, with
or without antibodies to platelets
• Exercise caution when administering NovoSeven® RT to patients
with an increased risk of thromboembolic complications, such as
those with disseminated intravascular coagulation (DIC), advanced
atherosclerotic disease, crush injury, septicemia, uncontrolled
post-partum hemorrhage, history of coronary heart disease, liver
disease, post-operative immobilization, in elderly patients, in
neonates, or in patients receiving concomitant treatment with aPCCs/
PCCs (activated or nonactivated prothrombin complex concentrates).
• Treatment of bleeding episodes and peri-operative management
in adults with acquired hemophilia
Important Safety Information
WARNING: THROMBOSIS
• Serious arterial and venous thrombotic events following
administration of NovoSeven® RT have been reported.
• Discuss the risks and explain the signs and symptoms of
thrombotic and thromboembolic events to patients who will
receive NovoSeven® RT.
• Monitor patients for signs or symptoms of activation of the
coagulation system and for thrombosis.
• Hypersensitivity reactions, including anaphylaxis, have been
reported with NovoSeven® RT. Administer only if clearly needed
in patients with known hypersensitivity to NovoSeven® RT, any of
its components, or mouse, hamster, or bovine proteins. Should
symptoms occur, discontinue NovoSeven® RT and administer
appropriate treatment.
• Factor VII deficient patients should be monitored for prothrombin
time (PT) and factor VII coagulant activity (FVII:C). If FVII:C fails to
reach the expected level, or PT is not corrected, or bleeding is not
controlled after treatment with the recommended doses, antibody
formation may be suspected and analysis for antibodies should be
performed.
• Laboratory coagulation parameters (PT/INR, aPTT, FVII:C) have shown
no direct correlation to achieving hemostasis.