NovoSeven - Novo Seven - Indications - Hemophilia With Inhibitors

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	Spotting Acquired Hemophilia

	Treating Acquired Hemophilia

Acquired Hemophilia is a rare but dangerous blood disorder, it occurs in up to four out of a million people yearly and has a 22% mortality rate.^27,28 With acquired hemophilia, patients are unable to create the hemostatic plug that is necessary to stop bleeding and occurs when the body produces antibodies against its own Factor VII or Factor IX blood clotting proteins. The disorder can occur in men and women, and often an underlying medical condition is involved.²⁸ The following sections provide information about acquired hemophilia and how to effectively treat it.

Acquired hemophilia is often difficult to recognize, but to spot it look for spontaneous and uncontrolled bleeding (gastrointestinal, retroperitoneal, purpura, etc.) with prolonged PPT.^30,31

The cause in more than half of the cases of acquired hemophilia is unknown. In the other half, the cause may be associated with a variety of immune modifying disorders.³²

Underlying diagnosis of patients with acquired hemophilia A³³

Acquired hemophilia may also be present with³⁰:

Gastrointestinal or urological bleeding
Retroperitoneal bleeding
Purpura and soft-tissue hemorrhage
Prolonged bleeding following surgery
Postpartum bleeding
Compartment syndrome

Acquired hemophilia may occur in patients with the following characters:

Median age of 64 years²⁹
Female or male²⁹
No personal or family history of bleeding disorders²⁸

Laboratory evaluation of acquired hemophilia

Prolonged PTT with normal PT, TT, and platelets³¹
Factor VIII levels decreases³¹

Use NovoSeven, the only recombinant therapy, for the treatment of bleeding episodes in patients with acquired hemophilia.

NovoSeven was effective in 78% of bleeding episodes
(number of episodes = 113)^32*

Effective as first-line therapy^32†

Effective as salvage therapy^32†

For the treatment of bleeding episodes in patients with acquired hemophilia. For the prevention of bleeding in surgical interventions of invasive procedures in patients with acquired hemophilia.

Contraindicated in patients with known hypersensitivity to NovoSeven, its components, or mouse, hamster, or bovine proteins.

Based on data collected from 4 studies in the compassionate use program conducted by Novo Nordisk and the Hemophilia and Thrombosis Research Society (HTRS) registry. A total of 70 patients with acquired hemophilia were treated with NovoSeven for 113 bleeding episodes, surgeries, or traumatic injuries.

†	Of the 70 patients, 61 were from the compassionate use program with 100 bleeding episodes (68 nonsurgical and 32 surgical bleeding episodes).

Recommended dosing:
70 - 90 µg/kg every 2-3 hours until hemostasis is achieved

IMPORTANT SAFETY INFORMATION

Most common adverse events: pyrexia, hemorrhage, injection site reaction, arthralgia, headache, hypertension, hypotension, nausea, vomiting, pain, edema, and rash.
Patients with disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, crush injury, septicemia, or concomitant treatment with activated or nonactivated prothrombin complex concentrates (aPCCs/PCCs) may have a potential risk of developing thrombotic events in association with NovoSeven treatment.
Contraindicated in patients with known hypersensitivity to NovoSeven, its components, or mouse, hamster, or bovine proteins.
Serious adverse events that may or may not have been related to the use of NovoSeven occurred in 14 of 298 patients with hemophilia A or B with inhibitors in the initial clinical program.

Additional Fair Balance for FVII Deficiency

Development of antibodies against FVII has been reported in FVII deficient patients after treatment with NovoSeven. These patients had previously been treated with human plasma and/or plasma-derived FVII.

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