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Full Prescribing Info
Moroctocog α (recombinant coagulation factor VIII).
XYNTHA is single-use vial containing nominally 250, 500 or 1000 International Units (IUs) of moroctocog alfa (recombinant coagulation factor VIII).
XYNTHA is used for the control and prevention of hemorrhagic episodes and for routine and surgical prophylaxis in patients with haemophilia A (congenital factor VIII deficiency or classic haemophilia). (XYNTHA is appropriate for use in children of all ages). XYNTHA does not contain von Willebrand factor, and therefore is not indicated in Von Willebrand's disease.
Dosage/Direction for Use
Treatment with XYNTHA should be initiated under the supervision of a physician experienced in the treatment of haemophilia A. Dosage and duration of treatment depend on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient's clinical condition. Individual patients may vary in their response to factor VIII, achieving different levels of recovery and demonstrating different half-lives. Doses administered should be titrated to the patient's clinical response. In the presence of an inhibitor, higher doses or appropriate specific treatment may be required. Dosage adjustment for patients with renal or hepatic impairment has not been studied in clinical trials. XYNTHA is appropriate for use in adults and children. The required dosage is determined using the following formula: see equation.

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Dosing for bleeding and surgery: Minor: 20-40 IU/dL repeat every 12-24 hours as necessary, until resolved. At least 1 day, depending upon the severity of the hemorrhage; Moderate: 30-60 IU/dL repeat infusion every 12-24 hours for 3-4 days or until adequate wound healing (For tooth extraction, a single infusion plus oral antifibrinolytic therapy within 1 hour may be sufficient.); Major: 60-100 IU/dL repeat infusion every 8-24 hours until threat is resolved or until adequate wound healing in the case of surgery, then therapy for at least another 7 days.
Dosage for prophylaxis: XYNTHA has been administered prophylactically in a pivotal clinical trial in adolescent and adult previously treated patients at a dose of 30 ± 5 IU/kg given 3 times weekly.
Hypersensitivity to any of the constituents of the preparation and in patients with a known history of hypersensitivity to hamster proteins.
Special Precautions
Hypersensitivity: If allergic or anaphylactic reactions occur, administration of XYNTHA should be stopped immediately and appropriate medical management should be given which may include treatment for shock.
Activity-neutralizing antibodies (inhibitors): If expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay should be performed to determine if a factor VIII inhibitor is present.
Use In Pregnancy & Lactation
XYNTHA should be administered to pregnant and lactating women only if clearly indicated.
Adverse Reactions
Very common: Factor VIII Inhibition (PUPs), Headache, Cough, Arthralgia, Pyrexia.
Common: Factor VIII Inhibition (PTPs), Decreased appetite, Dizziness, Haemorrhage; Haematoma, Diarrhoea; Vomiting; Abdominal pain; Nausea, Urticaria; Rash; Pruritus, Myalgia, Chills; Catheter site related reaction, Antibody test positive; Anti-factor VIII antibody positive; Human anti-mouse antibody positive; Liver function test abnormal.
Drug Interactions
No interactions of recombinant coagulation factor VIII products with other medicinal products are known.
XYNTHA should be stored under refrigeration at a temperature of 2° to 8°C (36° to 46°F) for up to 3 years. Within the expiration date, XYNTHA may also be stored at room temperature not to exceed 25°C (77°F) for one single period up to 3 months.
MIMS Class
ATC Classification
B02BD02 - coagulation factor VIII ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.
Powd for inj (vial + 4 mL pre-filled syringe + 1 vial adapter + 1 sterile infusion set + 2 alcohol swabs + 1 plaster + 1 gauze) 250 IU x 1's. 500 IU x 1's. 1,000 IU x 1's.
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