NovoSeven® RT
Coagulation Factor VIIa (Recombinant)
Rx only
BRIEF SUMMARY. Please consult package insert for full prescribing 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. [See Warnings
and Precautions]
INDICATIONS AND USAGE: NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) is a
coagulation factor indicated for: 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; Treatment of bleeding episodes and peri-operative management
in adults with acquired hemophilia
CONTRAINDICATIONS: None known.
WARNINGS AND PRECAUTIONS: Thrombosis: Serious arterial and venous thrombotic
events have been reported in clinical trials and postmarketing surveillance. Patients with disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, crush injury, septicemia,
or concomitant treatment with aPCCs/PCCs (activated or nonactivated prothrombin complex
concentrates) and uncontrolled post-partum hemorrhage have an increased risk of developing
thromboembolic events due to circulating tissue factor (TF) or predisposing coagulopathy [See
Adverse Reactions]. Exercise caution when administering NovoSeven® RT to patients with an
increased risk of thromboembolic complications. These include, but are not limited to, patients
with a history of coronary heart disease, liver disease, disseminated intravascular coagulation,
post-operative immobilization, elderly patients and neonates. In each of these situations,
the potential benefit of treatment with NovoSeven® RT should be weighed against the risk of
these complications. Monitor patients who receive NovoSeven® RT for development of signs
or symptoms of activation of the coagulation system or thrombosis. When there is laboratory
confirmation of intravascular coagulation or presence of cli