Recombinant & Viral Safety

NovoSeven® RT is made using a state-of-the-art process called recombinant technology. In this process, the human gene for Factor VII is singled out and copies are made in a laboratory. The copies are then cleansed and purified so that any impurities are removed. In the final steps of the process, the recombinant Factor VII is activated, yielding the finished NovoSeven® RT product.

Why Viral Safety Is Important

NovoSeven® RT contains no human albumin or human plasma-derived components. Viral safety—protection from viral transmission—is important for anyone with a bleeding disorder for two reasons:

Emerging Pathogens

Researchers have already found more than 1400 known pathogens that can infect and sicken humans. Each day, scientists around the world continue the search for previously unknown pathogens, called emerging pathogens, that may cause new diseases. Emerging pathogens often develop in animals and wildlife, then change or mutate and spread to humans.

During the past decade, several new pathogens have emerged or re-emerged, including:

  • West Nile virus
  • Severe Acute Respiratory Syndrome (SARS)
  • Monkeypox
  • Parvovirus
  • Ebola virus
  • Avian flu
  • Nipah virus
  • Variant Creutzfeldt-Jakob disease (vCJD)

Previously Infected Patients

Approximately 20,000 people have hemophilia in the United States. Of those, about 10% to 15% have been infected with HIV, and a large percentage have been infected with hepatitis C as a result of blood-product use. When a person is infected with a virus like HIV or hepatitis, the body's immune system must work overtime to fight off threats from the infection. Over time, this can weaken the immune system, leaving a person vulnerable to pathogens that are considered harmless to those with healthy immune systems.

For these reasons, it is very important to keep people who are already living with an infection from getting another infection. So viral safety is especially important to those with a bleeding disorder who were previously infected.