NovoSeven - Novo Seven - Recombinant Safety

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	Emerging Pathogens

	Previously Infected Patients

	Recombinant Safety

There are more than 1400 known pathogens that can infect and sicken humans,²² and each day, researchers around the world continue the search for pathogens that may cause new diseases. Doctors and scientists call these bacteria and viruses emerging pathogens. 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 reemerged, including:

			West Nile virus

			Severe Acute Respiratory Syndrome (SARS)

			Monkeypox

			Parvovirus

			Ebola virus

			Avian flu

			Nipah virus

			Variant Creutzfeldt-Jakob disease (vCJD)

Approximately 20,000 people have hemophilia in the United States.²³ Of those, about 10% to 15% have been infected with HIV²⁴, 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.

The goal is to keep people who are already living with an infection from getting another infection. Called co-infection, the presence of two or more infections in the blood system can put the body's immune system under a great deal of strain. Over time, this can weaken the immune system, leaving a person vulnerable to pathogens that are considered harmless to those with healthy immune systems.

Recombinant products are made without human blood or plasma. They can be used without the risk of human viral transmission.

IMPORTANT SAFETY INFORMATION

NovoSeven® was studied in 298 patients with hemophilia A or B with inhibitors treated for 1939 bleeding episodes.

The most common side effects in people taking NovoSeven were fever, bleeding, a decrease in the amount of coagulation factor 1, pain from blood collecting in a joint, and high blood pressure
People who have ever had a bad reaction to proteins from mice, hamsters, or "bovines" (such as an ox or cow) should not be treated with NovoSeven
After taking NovoSeven, some patients have more of a risk of thrombosis, which is when a clot forms in a blood vessel and causes harm. Although the extent of this risk is not known, it is thought to be small. Some patients have conditions that may increase this risk. These include clogged arteries, blood clots that form throughout the body instead of at the place of injury, a type of blood poisoning called septicemia, and crush injury, which is when a body part is crushed or squeezed between heavy or immobile objects. Also, people taking aPCCs/PCCs (activated or nonactivated prothrombin complex concentrates) at the same time that they're taking NovoSeven may be at increased risk for thrombosis.
Serious adverse events which may or may not have been related to the use of NovoSeven occurred in 14 of the 298 patients in the initial clinical program. Please see the enclosed prescribing information.
There have been no reports of NovoSeven causing bad reactions to "analgesics" (such as pain killers), "antibiotics" (the drugs used to treat infection), or "sedatives" (sleeping pills or tranquillizers).
Development of antibodies against Factor VII have been reported in Factor VII deficient patients after treatment with NovoSeven. These patients had previously been treated with human plasma and/or plasma-derived factor VII.

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

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