Afstyla

Afstyla

Manufacturer:

CSL Behring

Distributor:

Zuellig Pharma

Marketer:

Zuellig Pharma
Concise Prescribing Info
Contents
Lonoctocog α
Indications/Uses
Treatment & prophylaxis of bleeding in patients of all ages w/ haemophilia A (congenital factor VIII deficiency).
Dosage/Direction for Use
IV Max inj rate: 10 mL/min. Adult & adolescent ≥12 yr On-demand treatment Individualised dose. 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 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. Inj every 24 hr for 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 until adequate wound healing, then for at least another 7 days to maintain 30-60% factor VIII activity. Prophylaxis 20-50 IU/kg 2-3 times wkly. Childn 0 to <12 yr 30-50 IU/kg 2-3 times wkly.
Contraindications
Hypersensitivity. Known allergic reaction to hamster proteins.
Special Precautions
Discontinue immediately if hypersensitivity occurs. 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. Patients on controlled Na diet. Carefully monitor for development of inhibitors. Monitor lab tests. Pregnancy & lactation. Elderly >65 yr.
Adverse Reactions
FVIII inhibition in previously-untreated patients. Hypersensitivity; dizziness, paraesthesia; rash; pyrexia.
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
Afstyla powd for soln for inj 500 IU
Packing/Price
1's
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