Xyntha

Xyntha

Manufacturer:

Pfizer

Marketer:

Pfizer
Concise Prescribing Info
Contents
Moroctocog α (recombinant coagulation factor VIII)
Indications/Uses
Control & prevention of hemorrhagic episodes & for routine & surgical prophylaxis in patients w/ haemophilia A (congenital factor VIII deficiency/classic haemophilia).
Dosage/Direction for Use
Individualised dosage. Bleeding & surgery: Minor 20-40 IU/dL every 12-24 hr for at least 1 day, depending on the severity of the hemorrhage. Moderate 30-60 IU/dL infusion every 12-24 hr for 3-4 days or until adequate wound healing. Tooth extraction 30-60 IU/dL single infusion + oral antifibrinolytic therapy w/in 1 hr. Major 60-100 IU/dL infusion every 8-24 hr until threat is resolved or until adequate wound healing in the case of surgery, followed by at least another 7 days therapy. Previously treated adult & adolescent Prophylaxis 30 ± 5 IU/kg given 3 times wkly.
Contraindications
Hypersensitivity to moroctocog α (recombinant coagulation factor VIII) & in patients w/ hypersensitivity history to hamster proteins.
Special Precautions
Not indicated in patients w/ Von Willebrand's disease. Discontinue immediately if allergic or anaphylactic reactions occur; appropriate medical management should be given. Perform an assay to determine presence of factor VIII inhibitors if plasma levels are not attained or bleeding is not controlled. Pregnancy & lactation.
Adverse Reactions
Factor VIII inhibition (PUPs), headache, cough, arthralgia, pyrexia. Factor VIII inhibition (PTPs), decreased appetite, dizziness, haemorrhage; haematoma, diarrhoea; vomiting; abdominal pain; nausea, urticaria; rash; pruritus, myalgia, chills; catheter site related reaction, Ab test positive; anti-factor VIII Ab positive; human anti-mouse Ab positive; abnormal liver function test.
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
Xyntha powd for inj 1000 IU
Packing/Price
((1 pre-filled syringe @ 4 mL + 1 vial adapter + 1 sterile infusion set + 2 alcohol swabs + 1 plaster + 1 gauze)) 1's (Rp6,714,284/boks)
Form
Xyntha powd for inj 250 IU
Packing/Price
((1 pre-filled syringe @ 4 mL + 1 vial adapter + 1 sterile infusion set + 2 alcohol swabs + 1 plaster + 1 gauze)) 1's (Rp1,678,571/boks)
Form
Xyntha powd for inj 500 IU
Packing/Price
((1 pre-filled syringe @ 4 mL + 1 vial adapter + 1 sterile infusion set + 2 alcohol swabs + 1 plaster + 1 gauze)) 1's (Rp3,357,142/boks)
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