Xyntha

Xyntha

Manufacturer:

Pfizer

Distributor:

Pfizer
Concise Prescribing Info
Contents
Moroctocog α
Indications/Uses
Control & prevention of hemorrhagic episodes. Routine & surgical prophylaxis in patients w/ hemophilia A (congenital factor VIII deficiency or classic hemophilia).
Dosage/Direction for Use
Minor early hemarthrosis, superficial muscle or soft tissue & oral bleeds 20-40 IU/dL. Repeat every 12-24 hr as necessary until resolved. Duration: At least 1 day, depending upon the severity of the hemorrhage. Moderate hemorrhages into muscles, mild head trauma capitus, minor operations including tooth extraction, hemorrhages into the oral cavity 30-60 IU/dL. Repeat infusion every 12-24 hr for 3-4 days or until adequate hemostasis is achieved. For tooth extraction, a single infusion + oral antifibrinolytic therapy w/in 1 hr may be sufficient. Major GI bleeding, intracranial, intra-abdominal or intrathoracic hemorrhages, fractures, major operations 60-100 IU/dL. Repeat infusion every 8-24 hr until threat is resolved or in the case of surgery, until adequate local hemostasis is achieved, then continue therapy for at least another 7 days. Prophylaxis 30 ± 5 IU/kg given 3 times wkly.
Contraindications
Hypersensitivity to moroctocog α or hamster proteins.
Special Precautions
Discontinue use if anaphylaxis & severe hypersensitivity reactions occur. Not indicated in von Willebrand's disease. Development of activity-neutralizing Abs. May not be effective in patients w/ VIII inhibitors (especially high level inhibitors, >5 Bethesda units (BU)/mL. Perform assay that measures factor VIII inhibitor conc if expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled w/ an appropriate dose. Monitor periodically for the development of factor VIII inhibitors. Pregnancy & lactation. Elderly ≥65 yr.
Adverse Reactions
FVIII inhibition in PUPs. Vomiting. Hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension & anaphylaxis.
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 (lyo) 250 IU
Packing/Price
([single-use + 4 mL diluent (0.9% NaCl) pre-filled syringe]) 1's
Form
Xyntha powd for inj (lyo) 500 IU
Packing/Price
([single-use + 4 mL diluent (0.9% NaCl) pre-filled syringe]) 1's
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