Adynovate

Rurioctocog α pegol

Long-acting antihaemophilic factor (recombinant) in haemophilia A (congenital factor VIII deficiency) patients for control & prevention of bleeding episodes; routine prophylaxis to prevent or reduce frequency of bleeding episodes; peri-op management (surgical prophylaxis).

IV Max inj rate: 10 mL/min. On-demand treatment Individualised dose based on body wt, desired factor VIII rise, & reciprocal of observed recovery (0.5 dL/kg). Early haemarthrosis, muscle or oral bleeding 20-40 IU/dL required factor VIII level. Repeat inj every 12-24 hr for at least 1 day, until bleeding episode, as indicated by pain, is resolved or healing is achieved. More extensive haemarthrosis, muscle bleeding, or haematoma 30-60 IU/dL required factor VIII level. 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 required factor VIII level. Repeat inj every 8-24 hr until threat is resolved. Minor surgery (including tooth extraction) 30-60 IU/dL required factor VIII level. Repeat inj every 24 hr (12-24 hr for patient <6 yr), at least 1 day, until healing is achieved. Major surgery (pre- & post-op) 80-100 IU/dL required factor VIII level. Repeat inj every 8-24 hr (6-24 hr for patient <6 yr) until adequate wound healing, then continue therapy for at least another 7 days to maintain 30-60% factor VIII activity. Long-term prophylaxis 40-50 IU/kg twice wkly in 3- to 4-day intervals. Doses up to 60 IU/kg can be used in some cases. Prophylaxis in patient <12 yr 40-60 IU/kg twice wkly in 3- to 4-day intervals. Doses up to 80 IU/kg can be used in some cases.

Hypersensitivity, including anaphylaxis, to parent molecule Advate (octocog α), mouse or hamster protein, or other Adynovate constituents.

Immediately discontinue administration if hypersensitivity reactions occur. Carefully monitor for development of inhibitors; risk being highest w/in the 1st 20 exposure days. Increased CV risk in patients w/ existing CV risk factors. Risk of central venous access device (CVAD)-related complications including local infections, bacteraemia, & catheter site thrombosis if CVAD is required. Not indicated for treatment of von Willebrand disease. Safety & efficacy in previously untreated patients have not yet been established. Balance potential risks & only prescribe to pregnant & breastfeeding women if clearly needed. Patients on controlled Na diet. Elderly ≥65 yr.

Headache. Diarrhea, nausea; dizziness; rash, urticaria.

Haemostatics

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

P₁S₁S₃