Factor VIII (Recombinant)

Registered South African indications:

• Congenital Factor VIII deficiency
• Patients with Factor VIII inhibitors

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to mouse or hamster protein

Cautions

• Pregnancy
• Breastfeeding
• History of neutralising antibody (inhibitor) development to factor VIII
• Existing cardiovascular disease or risk factors
• Patients requiring central venous access device (CVAD)

Forms avail. in SA and covered in this monograph: inj

Bleeding disorders in congenital factor VIII deficiency
Patients with factor VIII inhibitors with:

• Joint, muscle and soft tissue haemorrhage - minor to major bleeding
• Mucous membrane bleeding
• Other severe haemorrhage e.g. central nervous system bleed
• Patients undergoing surgery
• Bleeding prophylaxis

Treatment should be advised by a Comprehensive Haemophilia Treatment Centre found across South Africa. See Care Coord section for contact numbers

The dosage, frequency and duration of the therapy is dependent upon the severity of the disorder, the location and extent of the bleeding, the patient's weight and clinical condition

See adult dosage

Pregnancy

• Caution
• Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII (recombinant) during pregnancy is not available
• Therefore, factor VIII (recombinant) should only be used during pregnancy if clearly indicated

Breastfeeding

• Caution; no information available
• Based on the rare occurence of haemophilia A in women, experience regarding the use of factor VIII (recombinant) during breastfeeding is not available
• Therefore, factor VIII (recombinant) should only be used during breastfeeding if clearly indicated

Fertility

• There is no fertility data available

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended,

Elderly

• No dose adjustment recommended,

Porphyria Information

• Not porphyrinogenic (NP) 

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Dizziness

Cardiovascular Disorders

• Abnormal blood pressure

Gastrointestinal Disorders

• Dysgeusia
• Nausea

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Rash
• Urticaria
• Injection site reactions
• Infusion related febrile reaction

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
• Anaphylaxis (including shock)
• Factor VIII inhibition

No information available

• Plasma factor VIII activity
• Development of factor VIII inhibitors
• Cardiac risk factors

Formation of Inhibitors to Factor VIII

• The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, quantified in Bethesda Units (BU) per mL of plasma using the modified assay
• The risk of developing inhibitors is correlated to the severity of the disease and the exposure to factor VIII with this risk being highest within the first 20 exposure days. Rarely, inhibitors may develop after the first 100 exposure days
• Cases of recurrent inhibitor (low titre) have been observed after switching from one factor VIII product to another in previously treated patients with more than 100 exposure days with a previous history of inhibitor development
• In general, all patients treated with coagulation factor VIII products should be monitored for the development of inhibitors by appropriate clinical observations and laboratory tests. If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed. In patients with high levels of inhibitor, factor VIII therapy may not be effective and other therapeutic options should be considered

Traceability

• It is recommended that every time factor VIII (recombinant) is administered to a patient, the name and batch number of the product are recorded to maintain a link between the patient and the batch of the medicinal product

Precautions for use

• Only the provided components should be used for reconstitution and injection as factor VIII (recombinant) may adsorb to the internal surfaces of some infusion equipment
• After reconstitution, the solution is clear and colourless. Do not use the product if you notice visible particulate matter or turbidity
• After reconstitution, the product should be used immediately. It not immediately used, storage times and conditions prior to use are the responsibility of the user

Factor VIII binds to von Willebrand factor (vWF) in the patient's circulation to form the factor VIII/vWF complex. Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin and a blood clot can be formed. This enables a temporary correction of the factor deficiency and correction of the bleeding tendencies.

Injection (per vial) 250iu

• Kogenate FS (Bayer) originator
• Kovaltry 250 (Bayer)

Injection (per vial)  500iu

• Kogenate FS (Bayer) originator
• Kovaltry 500 (Bayer)

 Injection (per vial) 1000iu

• Kogenate FS (Bayer) originator
• Kovaltry 1000 (Bayer)