Getting an inhibitor
was like a punch
in the gut...
…so I chose
NovoSeven® RT
because it’s
recombinant.
—Christina
CADEN AND CHRISTINA
Caden 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 postpartum 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 bl eeding 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.