NovoSeven RT

What it is

NovoSeven RT contains activated recombinant coagulation Factor VII of approximate molecular mass 50K Daltons produced by genetic engineering from baby hamster kidney cells (BHK cells). The recombinant coagulation Factor VIIa (rFVIIa) in NovoSeven RT is structurally very similar to human plasma-derived activated Factor VIIa. NovoSeven RT is supplied as a stable, sterile, freeze-dried white powder in single-use vials, and solvent, for solution for injection.

Approved indications

NovoSeven RT is indicated for the control of bleeding and surgical prophylaxis in patients: — with inhibitors to coagulation Factors VIII or IX; — with congenital FVII deficiency; — with Glanzmann's Thrombasthenia, who have antibodies to GPIIb-IIIa and/or HLA, and with past or present refractoriness to platelet transfusions.

Dosing overview Dosing varies by indication and clinical context:

NovoSeven RT must be reconstituted with the sterile solvent provided and then administered by intravenous bolus injection over a period of 2–5 minutes. Current clinical experience does not warrant a general differentiation in dosing between children and adults, although 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.

Key safety warnings

Patients who receive NovoSeven RT should be kept under close observation in case they develop signs and symptoms of untoward activation of the coagulation system or thrombosis. Any findings of this nature indicate that the dosage should be reduced or treatment stopped, depending on the patient's symptoms. In pathological conditions in which tissue factor may be expressed more extensively than considered normal, there may be a potential risk of development of thrombotic events or induction of disseminated intravascular coagulation (DIC) in association with rFVIIa treatment. Such situations may include patients with advanced atherosclerotic disease, crush injury, septicaemia or DIC. Because of the risk of thromboembolic complications, caution should be exercised when administering NovoSeven RT to patients with a history of coronary heart disease, to patients with liver disease, to patients undergoing and following major surgery, to neonates, or to patients at risk of thromboembolic phenomena or disseminated intravascular coagulation. In each of these situations, the potential benefit of treatment with NovoSeven RT should be weighed against the risk of these complications. As recombinant coagulation factor VIIa contains trace amounts of mouse IgG protein (maximum of 1.2 ng/mg rFVIIa), bovine IgG protein (maximum of 30 ng/mg rFVIIa) and hamster and other bovine proteins (maximum of 19 ng BHK protein/mg rFVIIa), there is a remote possibility that patients treated with NovoSeven RT may develop hypersensitivity to these proteins. In such cases, standard medical treatment should be considered. If allergic or anaphylactic-type reactions occur, the administration should be discontinued immediately. In case of anaphylactic shock, standard medical treatment for shock should be implemented. Patients should be informed of the early signs of hypersensitivity reactions. If such symptoms occur, the patient should be advised to discontinue use of the product immediately and contact their physician.

Contraindications

NovoSeven RT is contraindicated in patients with hypersensitivity to rFVIIa or any of the components of NovoSeven RT, or hypersensitivity to mouse, hamster or bovine proteins.

Regulatory history

NovoSeven RT was first listed on the ARTG on 1 May 2013. Four strengths are registered: 1 mg, 2 mg, 5 mg and 8 mg powder for injection vials with pre-filled diluent syringe.