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	Hemophilia With Inhibitors

	FVII Deficiency—Bleeding Episodes and Surgery

Bleeding episodes

The recommended dosage for NovoSeven is 90 µg/kg every 2 hours based on the patient’s body weight and how long it takes to stop the bleed, although dosage may vary. NovoSeven is given as an intravenous (IV) bolus injection and takes 2 to 5 minutes to administer.

Surgical procedures

The hematologist and surgeon will develop a treatment plan for the patient prior to surgery. The plan will define exactly when the patient will receive doses of NovoSeven before and during surgery. The doctor will use a dosing calculator to make sure the correct amount of NovoSeven is given.

For example, a patient may receive a dose of NovoSeven 30 minutes to 1 hour before the procedure is supposed to begin. Dosing will likely continue after surgery on a case-by-case basis.

The physician will have clear instruction on how to dose NovoSeven before, during, and after surgery.

For more information on hemophilia and inhibitors, click here.

Bleeding episodes and surgical procedures

NovoSeven Coagulation Factor VIIa (Recombinant) requires much less infusion volume than the plasma-derived treatment alternatives.¹ The indicated dosage of NovoSeven for FVII deficiency is considerably less than that indicated for treatment of hemophilia patients with inhibitors.¹

The recommended dose range for treatment of bleeding episodes in congenital FVII-deficient patients, or for the prevention of bleeding episodes in surgical interventions in FVII-deficient patients, is 15–30 µg/kg body weight every 4–6 hours until hemostasis is achieved. Effective treatment has been achieved with doses as low as 10 µg/kg in non-surgical bleeding episodes.

For more information on FVII deficiency, click here.

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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