factor viii




Zuellig Pharma


Concise Prescribing Info
Pegylated recombinant human coagulation factor VIII (rDNA)
Prophylaxis & treatment of bleeding in patients ≥12 yr w/ haemophilia A (congenital factor VIII deficiency).
Dosage/Direction for Use
IV Administer at a max rate of 10 mL/min. Adult & patients 12-18 yr The doses & intervals may be considered based on achieved FVIII levels & individual bleeding tendency. Early haemarthrosis, muscle or oral bleeding 20-40 IU/dL. Repeat inj every 12-24 hr at least 1 day until bleeding episode is resolved or healing is achieved. More extensive haemarthrosis, muscle bleeding or haematoma 30-60 IU/dL. Repeat inj every 12-24 hr for 3-4 days or more until pain & acute disability are resolved. Life threatening haemorrhages 60-100 IU/dL. Repeat inj every 8-24 hr until threat is resolved. Minor surgery including tooth extraction 30-60 IU/dL every 24 hr at least 1 day until healing is achieved. Major surgery (pre- & post-op) 80-100 IU/dL. Repeat inj every 8-24 hr until adequate wound healing, then continue treatment for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dL). Long-term prophylaxis 40-50 IU/kg twice wkly in 3-4 day intervals.
Hypersensitivity to factor VIII & octocog alfa. Known allergic reaction to mouse or hamster protein.
Special Precautions
Discontinue if symptoms of hypersensitivity (eg, hives, generalised urticaria, chest tightness, wheezing, hypotension, anaphylaxis) occur. Carefully monitor patients for neutralising antibodies (inhibitors) occurrence following any product switch. Perform testing for the presence of factor VIII inhibitors if the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled w/ an appropriate dose. Patients w/ high levels of inhibitor & existing CV risk factors. Immune tolerance induction. Consider risk of central venous access device (CVAD) related complications eg, local infections, bacteraemia & catheter site thrombosis in patients requiring CVAD. Patients on a controlled Na diet.
Adverse Reactions
MIMS Class
ATC Classification
B02BD02 - coagulation factor VIII ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.
Adynovate powd for soln for inj 500 IU/2 mL
((+ solvent)) 1's
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