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]
trials of a drug product cannot be directly compared to rates in clinical trials of another drug, and
may not reflect rates observed in practice. Adverse reactions outlined below have been reported
from clinical trials and data collected in registries. Hemophilia A or B Patients with Inhibitors: In
two studies for hemophilia A or B patients with inhibitors treated for bleeding episodes (N=298),
adverse reactions were reported in ≥2% of the patients that were treated with NovoSeven® for
1,939 bleeding episodes (see Table below).
Table: Adverse Reactions Reported in ≥2% of the 298 Patients with Hemophilia A
or B with Inhibitors
Body System
# of adverse reactions
# of patients
Reactions
(n=1,939 treatments)
(n=298 patients)
Body as a whole
Fever
16
13
Platelets, Bleeding, and Clotting
Fibrinogen plasma decreased
10
5
Cardiovascular
Hypertension
9
6
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
Serious adverse reactions included thrombosis, pain, thrombophlebitis deep, pulmonary
CONTRAINDICATIONS: None known.
embolism, decreased therapeutic response, cerebrovascular disorder, angina pectoris, DIC,
WARNINGS AND PRECAUTIONS: Thrombosis: Serious arterial and venous thrombotic anaphylactic shock and abnormal hepatic function. The serious adverse reactions of DIC and
events have been reported in clinical trials and postmarketing surveillance. Patients with dissemi- therapeutic response decreased had a fatal outcome. There have been no confirmed reports
nated intravascular coagulation (DIC), advanced atherosclerotic disease, crush injury, septicemia, of inhibitory antibodies against NovoSeven® or FVII in patients with congenital hemophilia
or concomitant treatment with aPCCs/PCCs (activated or nonactivated prothrombin complex A or B with alloantibodies. In two clinical trials evaluating safety and efficacy of NovoSeven®
concentrates) and uncontrolled post-partum hemorrhage have an increased risk of developing administration in the peri-operative setting in hemophilia A or B patients with inhibitors (N=51),
thromboembolic events due to circulating tissue factor (TF) or predisposing coagulopathy [See the following serious adverse reactions were reported: acute post-operative hemarthrosis
Adverse Reactions]. Exercise caution when administering NovoSeven® RT to patients with an (n=1), internal jugular thrombosis adverse reaction (n=1), decreased therapeutic response
increased risk of thromboembolic complications. These include, but are not limited to, patients (n=4) Congenital Factor VII Deficiency: Data collected from the compassionate/emergency
with a history of coronary heart disease, liver disease, disseminated intravascular coagulation, use programs, the published literature, a pharmacokinetics study, and the Hemophilia and
post-operative immobilization, elderly patients and neonates. In each of these situations, Thrombosis Research Society (HTRS) registry showed that 75 patients with Factor VII deficiency
the potential benefit of treatment with NovoSeven® RT should be weighed against the risk of had received NovoSeven®: 70 patients for 124 bleeding episodes, surgeries, or prophylaxis; 5
these complications. Monitor patients who receive NovoSeven® RT for development of signs patients in the pharmacokinetics trial. The following adverse reactions were re