KOVALTRY

What it is

Kovaltry is octocog alfa, a full length recombinant human coagulation factor VIII produced using recombinant DNA technology. It is produced by Baby Hamster Kidney cells into which the human factor VIII gene has been introduced. Kovaltry is available in five dose strengths: 250 IU, 500 IU, 1000 IU, 2000 IU, and 3000 IU.

Approved indications

— Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). — Use in all age groups.

Dosing overview

Dosage and duration of substitution therapy must be individualised according to the patient's needs, including weight, severity of the haemostatic disorder, the site and extent of bleeding, inhibitor titre, and the desired factor VIII level. One International Unit of factor VIII per kg body weight raises plasma factor VIII activity by 1.5% to 2.5% of normal activity. **On-demand treatment:** The usual single dose is 10–30 IU/kg body weight. Higher dosages are recommended for life-threatening or major haemorrhages. **Prophylaxis:** For long-term prophylaxis in adolescents (>12 years) and adults with severe haemophilia A, the usual doses are 20 to 40 IU per kg body weight two to three times per week. The recommended prophylaxis doses for paediatric patients are 20–50 IU/kg twice weekly, three times weekly or every other day according to individual requirements.

Key safety warnings

Allergic-type hypersensitivity reactions are possible with Kovaltry, as the product may contain traces of hamster or mouse proteins which in some patients may cause allergic reactions. Patients should be made aware that chest tightness, dizziness, mild hypotension and nausea during infusion could constitute an early warning for hypersensitivity and anaphylactic reactions. The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in haemophilia A management, with risk highest within the first 20 exposure days and correlated to exposure to factor VIII and other genetic and environmental factors. All patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests. Haemophiliac patients with cardiovascular risk factors or diseases may be at the same risk of developing cardiovascular events as non-haemophiliac patients when clotting has been normalised by factor VIII treatment.

Contraindications

Hypersensitivity to the active substance or to any of the excipients, and known allergic reactions to mouse or hamster protein.

Regulatory history

Kovaltry was first listed on the Australian Register of Therapeutic Goods on 1 April 2016 with five registered presentations across 250 IU, 500 IU, 1000 IU, 2000 IU, and 3000 IU strengths.