Aleviate

Coagulation factor VIII, von Willebrand factor complex (human)

Prophylaxis & treatment of non-surgical & surgical bleeding in patients w/ von Willebrand disease (VWD) when desmopressin treatment is ineffective or contraindicated; non-surgical & surgical bleeding associated w/ factor VIII (FVIII) deficiency due to haemophilia A.

IV Individualized dose. VWF & FVIII are present in a ratio of 2:1. VWD population Spontaneous bleeding episodes Initially 10-20 IU FVIII:C/kg (= 25-50 IU VWF:Ac/kg) (target peak level: FVIII >30%, VWF >50%). Subsequently 10 IU FVIII:C/kg (= 25 IU VWF:Ac/kg) every 12-24 hr until bleeding stops (target trough FVIII/VWF level >30%). Minor surgery 25 IU FVIII:C/kg (= 60 IU VWF:Ac/kg) daily until healing is complete (target trough FVIII/VWF level >30%). Major surgery Initially 25-35 IU FVIII:C/kg (= 60-80 IU VWF:Ac/kg) (target peak level: FVIII >60%, VWF >100%). Subsequently 15-25 IU FVIII:C/kg (= 30-60 IU VWF:Ac/kg) every 12-24 hr until healing is complete (target trough FVIII/VWF level >50%). Prophylaxis 10-15 IU FVIII:C/kg (= 25-40 IU VWF:Ac/kg) 1-3 times wkly (target trough FVIII/VWF >1%). VWD paed patient <12 yr Prophylaxis 40-80 IU VWF:Ac/kg 1-3 times wkly. Haemophilia A population Minor bleeding episodes 10-15 IU/kg 12-24 hrly for 1-2 days (target peak FVIII 20-30%). Moderate to severe bleeding episodes eg, haemarthroses 15-40 IU/kg 8-24 hrly for 1-4 days (target peak FVIII 30-80%). Life-threatening bleeding eg, intracranial haemorrhage Day 1: Single dose of 50-60 IU/kg (target peak FVIII >100%). Days 2-10: 20-25 IU/kg 8-12 hrly (target trough FVIII 80-100%). Minor surgery Pre-op: Single dose of 20-30 IU/kg (target peak FVIII 40-60%). Days 1-3: 20-25 IU/kg 12 hrly (target trough FVIII 40-50%). Day 4 onwards: 20-30 IU/kg 24 hrly (target trough FVIII 20-30%). Major surgery Pre-op: Single dose of 40-50 IU/kg (target peak FVIII 80-100%). Days 1-3: 20-25 IU/kg 8-12 hrly (target trough FVIII 80-100%). Days 4-6: 15-20 IU/kg 8-12 hrly (target trough FVIII 60-80%). Day 7 onwards: 10-20 IU/kg 12 hrly (target trough FVIII 40-60%). Dentistry eg, invasive dental procedures, extractions, surgery Pre-op: Single dose of 35-40 IU/kg (target peak FVIII 70-80%). Days 1-3: 25-30 IU/kg 12 hrly (target trough FVIII 50-60%). Prophylaxis 25-40 IU/kg 3 times wkly (target trough FVIII 1%).

Hypersensitivity. History of anaphylactic or severe systemic response to coagulation FVIII &/or VWF prep.

Possible allergic type hypersensitivity reactions; discontinue use if symptoms occur. Monitor for FVIII/VWF inhibitor development. Risk of thrombotic events. Possibility of transmitting infective agents. Consider appropriate vaccination (hepatitis A & B) for patients in regular/repeated receipt of human plasma-derived products. Pregnancy & lactation. Elderly.

Headache. Hypersensitivity (including tachycardia, chest pain/discomfort, back pain); pyrexia.

Haemostatics

B02BD02 - coagulation factor VIII ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.

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