NOVOSEVEN® POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 1MG [SIN13933P]

Product Info

NOVOSEVEN® POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 1MG

[SIN13933P]

Therapeutic indications
NovoSeven® is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups:

• in patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX > 5 Bethesda Units (BU)

• in patients with congenital haemophilia who are expected to have a high anamnestic response to factor VIII or factor IX administration

• in patients with acquired haemophilia

Posology and method of administration
Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia and/or bleeding disorders.
Posology

Haemophilia A or B with inhibitors or expected to have a high anamnestic response
Dose
NovoSeven® should be given as early as possible after the start of a bleeding episode. The recommended initial dose, administered by intravenous bolus injection, is 90 mcg per kg body weight.
Following the initial dose of NovoSeven®, further injections may be repeated. The duration of treatment and the interval between injections will vary with the severity of the haemorrhage, the invasive procedures or surgery being performed.

Dosing in children
Current clinical experience does not warrant a general differentiation in dosing between children and adults, although young children have faster clearance than adults. Therefore, higher doses of rFVIIa may be needed in paediatric patients to achieve similar plasma concentrations as in adult patients, see Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Dose interval
Initially 2 – 3 hours to obtain haemostasis.
If continued therapy is needed, the dose interval can be increased successively once effective haemostasis is achieved to every 4, 6, 8 or 12 hours for as long as treatment is judged as being indicated.

Mild to moderate bleeding episodes (including home therapy)
Early intervention has been shown to be efficacious in the treatment of mild to moderate joint, muscle and mucocutaneous bleeds. Two to three injections of 90 mcg per kg body weight administered at three-hour intervals. If further treatment is required, one additional dose of 90 mcg per kg body weight can be administered. The duration of the home therapy should not exceed 24 hours. Only after consultation with the haemophilia treatment centre can continued home treatment be considered.

Serious bleeding episodes
An initial dose of 90 mcg per kg body weight is recommended and could be administered on the way to the hospital where the patient is usually treated. The following dose varies according to the type and severity of the haemorrhage. Dosing frequency should initially be every second hour until clinical improvement is observed. If continued therapy is indicated, the dose interval can then be increased to 3 hours for 1 – 2 days. Thereafter, the dose interval can be increased successively to every 4, 6, 8 or 12 hours for as long as treatment is judged as being indicated. A major bleeding episode may be treated for 2 – 3 weeks but can be extended beyond this if clinically warranted.

Invasive procedure/surgery
An initial dose of 90 mcg per kg body weight should be given immediately before the intervention. The dose should be repeated after 2 hours and then at 2 – 3 hour intervals for the first 24 – 48 hours depending on the intervention performed and the clinical status of the patient. In major surgery, the dose should be continued at 2 – 4 hour intervals for 6 – 7 days. The dose interval may then be increased to 6 – 8 hours for another 2 weeks of treatment. Patients undergoing major surgery may be treated for up to 2 – 3 weeks until healing has occurred.

Acquired Haemophilia
Dose and dose interval
NovoSeven® should be given as early as possible after the start of a bleeding episode. The recommended initial dose, administered by intravenous bolus injection, is 90 mcg per kg body weight. Following the initial dose of NovoSeven®, further injections may be given if required. The duration of treatment and the interval between injections will vary with the severity of the haemorrhage, the invasive procedures or the surgery being performed.
The initial dose interval should be 2 – 3 hours. Once haemostasis has been achieved, the dose interval can be increased successively to every 4, 6, 8, or 12 hours for as long as treatment is judged to be indicated.

Method of administration
Reconstitute the solution as described under NovoSeven® user instructions and slowly administer as an intravenous bolus injection over 2–5 minutes.

Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in List of excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information, or to mouse, hamster or bovine protein.