Hemophilia With Inhibitors Factor VII Deficiency Acquired Hemophilia Surgery Information About NovoSeven Recombinant Safety SevenSECURE
Overview
What Is Hemophilia?
What Causes Hemophilia?
What Are the Symptoms?
Blood Basics
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Blood Basics
Blood circulates through the body by a system of tubes or vessels called veins, arteries, and capillaries. When these vessels are damaged, blood flows into the organ or muscle that they line.
Blood contains red blood cells, white blood cells, platelets, and plasma. Plasma contains proteins like albumin, antibodies, clotting factors, and electrolytes. All of these things in the blood keep the body working properly by delivering oxygen and nutrients, fighting infections, and healing injuries through the blood-clotting process.
The blood-clotting process is what makes bleeding stop at the site of an injury. Normally, when bleeding occurs, the blood responds in 2 phases to stop it.
During the first phase, the blood vessel shrinks and platelets become sticky and clump together at the site of the injury to form a temporary plug1
During the second phase, the temporary platelet plug is replaced by a fibrin clot, which seals the opening. This phase involves a chain reaction of clotting factors to create this clot1
Figure 1: The Formation of a Fibrin Clot
The Formation of a Fibrin Clot
[images of damaged vessel wall, platelet plug, and then fibrin clot over it]
If there is an insufficient amount of clotting factor, the reaction needed to make a fibrin clot breaks down, and bleeding continues. Treatment for hemophilia bleeds usually includes factor replacement therapy—injecting or infusing the missing or deficient clotting factor into the blood so the body can complete the clotting process.
The longer—and more often—a bleed remains uncontrolled, the more likely it will result in permanent damage, especially to joints and muscles.
Hemophilia Treatment Center at Orthopaedic Hospital, Los Angeles
Courtesy of Drs. James V. Luck Jr. and Mauricio Silva

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.
© 2008 Novo Nordisk Inc. All Rights Reserved 130601R1 June 2008