NovoSeven - Novo Seven - Viral Safety

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When it comes to treating bleeding disorders, viral safety is an important consideration. In the past decade, stringent screening and purification techniques have helped improve the safety of blood- and plasma-based replacement coagulation factors. The advent of recombinant factor products has established a new era of safety for the bleeding-disorder community. The following section gives an overview of viral safety followed by a description of recombinant safety and its practical benefits.

IMPORTANT SAFETY INFORMATION

Most common adverse events: pyrexia, hemorrhage, injection site reaction, arthralgia, headache, hypertension, hypotension, nausea, vomiting, pain, edema, and rash.
Patients with disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, crush injury, septicemia, or concomitant treatment with activated or nonactivated prothrombin complex concentrates (aPCCs/PCCs) may have a potential risk of developing thrombotic events in association with NovoSeven treatment.
Contraindicated in patients with known hypersensitivity to NovoSeven, its components, or mouse, hamster, or bovine proteins.
Serious adverse events that may or may not have been related to the use of NovoSeven occurred in 14 of 298 patients with hemophilia A or B with inhibitors in the initial clinical program.

Additional Fair Balance for FVII Deficiency

Development of antibodies against FVII has been reported in FVII deficient patients after treatment with NovoSeven. These patients had previously been treated with human plasma and/or plasma-derived FVII.

Novo Nordisk is a registered trademark of Novo Nordisk A/S.

NovoSeven is a registered trademark of Novo Nordisk Health Care AG.

130601R1 June 2008