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Hemophilia With Inhibitors Factor VII Deficiency Acquired Hemophilia Surgery Information About NovoSeven Recombinant Safety SevenSECURE
What Is NovoSeven? Efficacy Safety Dosing Convenience
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Safety
NovoSeven is not only effective and convenient, it's also safe. NovoSeven is made through recombinant technology—which means it contains no human plasma-derived components. In fact, it is the first and only FDA-approved recombinant product for the treatment of bleeding episodes and surgical procedures in people with FVII deficiency or hemophilia with inhibitors to FVIII or FIX.
Because NovoSeven is recombinant, it presents no risk of human viral transmission. NovoSeven is also considered safe because it works at the site of injury.18,19 So if you’re having a bleed, NovoSeven works right where it's needed.
Clinical data showed that NovoSeven worked in 91% of joint bleeds14
and 86% of muscle bleeds in as few as 5 hours.14,15
Talk with your doctor or nurse about these important safety features of NovoSeven:
Low incidence of adverse events
No potential for an anamnestic response (no increase in inhibitor titer),
as shown in clinical studies20
NovoSeven is well tolerated by a vast majority of patients. In clinical studies, the most common side effect was fever, which occurred in about 4% of patients and was considered to be at least a possibility or of unknown relationship to NovoSeven administration. The most common adverse reactions observed during clinical studies for each of the labeled indications of NovoSeven were pyrexia, hemorrhage, injection site reaction, arthralgia, headache, hypertension, hypotension, nausea, vomiting, pain, edema, and rash.

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
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Hemophilia With Inhibitors Factor VII Deficiency Surgery Information About NovoSeven Recombinant Safety SevenSECURE