Adynovate

Adynovate

factor viii

Manufacturer:

Takeda

Distributor:

Zuellig Pharma

Marketer:

Takeda
Concise Prescribing Info
Contents
Pegylated recombinant human coagulation factor VIII (rDNA)
Indications/Uses
Prophylaxis & treatment of bleeding in adults & childn w/ haemophilia A (congenital factor VIII deficiency).
Dosage/Direction for Use
IV Administer at max rate of 10 mL/min. 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 factor VIII activity of 30-60% (IU/dL). Long-term prophylaxis 40-50 IU/kg twice wkly in 3-4 day intervals. Childn <12 yr Initially 40-60 IU/kg twice wkly. Adjust dose based on clinical response up to max of 70 IU/kg.
Contraindications
Hypersensitivity to factor VIII & octocog α. 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. Risk of central venous access device (CVAD) related complications eg, local infections, bacteraemia & catheter site thrombosis in patients requiring CVAD. Patients w/ high levels of inhibitor; existing CV risk factors; on controlled Na diet. Previously treated patients w/ >100 exposure days & history of inhibitor development. Immune tolerance induction. Carefully monitor patients for inhibitor occurrence following any product switch. Perform testing for presence of factor VIII inhibitors if the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled w/ appropriate dose. Pregnancy & lactation.
Adverse Reactions
MIMS Class
Haemostatics
ATC Classification
B02BD02 - coagulation factor VIII ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.
Presentation/Packing
Form
Adynovate powd for soln for inj 500 IU/2 mL
Packing/Price
((+ solvent)) 1's
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