Factor VIII

Registered South African indications:

• Haemophilia A 
• Acquired Factor VIII deficiency 
• von Willebrand disease

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• If a gel forms on reconstitution, the preparation must not be used
• Do not give concomitantly with other medicines
• Development of inhibitors
• Risk of transmission of infectious agents
• Immunodeficiency 
• Increased erythropoiesis
• Low sodium diet

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

Haemophilia A (congenital factor VIII deficiency)
Acquired factor VIII deficiency
Haemorrhage in patients with von Willebrand disease (VWD)
Surgical bleeding in patients with von Willebrand disease (VWD)
Prophylaxis in Willebrand disease (VWD)

• Minor Bleed: IV: 20-40 IU/kg 
• Major Bleed: IV: 40-50 IU/kg

Expected response: 1 IU/kg = 2% rise in Factor VIII level

The Haemophilia Treatment Centre physician chooses the most suitable product for each patient. Please follow these recommendations

Round off dose to the nearest vial; do not discard excess Factor VIII but rather infuse it

Repeat doses may be required depending upon the severity of bleeding: major bleeds usually require repeat dosing every 12-24 hours

Patients undergoing surgery

• Minor Surgery: IV: 30-60 IU/kg, every 24hrs, at least 1 day, until healing is achieved
• Major Surgery: IV: 80-100 IU/kg ((re- and postoperative); Repeat infusion every 8-24hrs until adequate wound healing, then therapy for at least another 7 days to maintain a FVIII activity of 30% to 60%

Prophylaxis in haemophilia A

• Haemophilia A: 25-40 IU/kg, 2-3 times per week

Rationale for prophylaxis is to maintain Factor activity above 1% converting a bleeding pattern from severe to mild/moderate

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

See adult dosage

Pregnancy

• Caution
• There is no or limited amount of data from the use of this agent in pregnant women
• Animal reproduction studies have not been conducted with factor VIII. Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy is not available. Therefore, factor VIII should be used during pregnancy only if clearly indicated

Breastfeeding

• Caution
• It is unknown if factor VIII is excreted in human milk
• Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during breastfeeding is not available. Therefore, factor VIII should be used during breastfeeding only if clearly indicated

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 warning

Central Nervous System Disorders

• Light-headedness
• Headache
• Fatigue
• Hypotension
• Restlessness

Cardiovascular Disorders

• Flushing
• Thrombotic events
• Tachycardia

Respiratory Disorders

• Tightness of the chest
• Wheezing

Gastrointestinal Disorders

• Dry mouth
• Unpleasant taste
• Nausea and vomiting

Skin and Subcutaneous Tissue Disorders

• Urticaria

Immune, Blood and Lymphatic System Disorders

• Allergic reactions
• Anaphylaxis
• Angioedema
• Platelet disorders
• Bleeding disorders
• Clotting disorders
• Inhibitors may develop

Others

• Burning at the injection site
• Inflammation at the injection site
• Chills
• Fever

• No information available

• Coagulation analysis
• Factor VIII inhibitors

Factor VIII is an endogenous glycoprotein necessary for blood clotting and haemostasis. The active cofactor, factor VIIIa, is necessary for factor IX to activate factor X in the intrinsic pathway. In haemophilia A, there is a deficiency of this clotting factor.

Injection (per 5ml) 250iu

• Octanate 250 (Octapharma) originator

Injection (per 10ml) 500iu

• Octanate 500 (Octapharma) originator

 Injection (per 10ml) 1000iu

• Octanate 1000 (Octapharma) originator
• Haemosolvate Factor VIII 1000 IU (National Bioproducts )

Injection (per vial) 300iu

• Haemosolvate Factor VIII 300 IU (National Bioproducts)

Injection (per vial) 500iu

• Haemosolvate Factor VIII 500 IU (National Bioproducts)