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Xyntha

Xyntha

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Moroctocog alfa (recombinant coagulation factor VIII)
Indications/Uses
On-demand treatment & control of bleeding episodes; perioperative management; routine prophylaxis to reduce the frequency of bleeding episodes in adults & childn w/ hemophilia A (congenital factor VIII deficiency).
Dosage/Direction for Use
IV Individualized dosage. Early hemarthrosis, minor muscle/oral bleeds 20-40 IU/dL 12-24 hrly for at least 1 day. Moderate (bleeding into muscles/oral cavity, mild head trauma 30-60 IU/dL 12-24 hrly for 3-4 days. GI, intracranial, intra-abdominal or intrathoracic bleeding, fractures 60-100 IU/dL 8-24 hrly. Minor surgery 30-60 IU/dL every 12-24 hr for 3-4 days. Tooth extraction 30-60 IU/dL single infusion + oral antifibrinolytic therapy w/in 1 hr. Routine prophylaxis Adult & adolescents ≥12 yr 30 IU/kg 3x wkly. Childn <12 yr Initially, 25 IU/kg every other day.
Contraindications
Patients w/ life-threatening immediate hypersensitivity reactions, including anaphylaxis to moroctocog alfa & hamster proteins.
Special Precautions
Discontinue treatment if hypersensitivity symptoms occur. Hypersensitivity to non-human mammalian proteins eg, hamster proteins. Not indicated in patients w/ von Willebrand's disease. Monitor patients for development of factor VIII inhibitors. Perform an assay that measures the presence of factor VIII inhibitor conc if expected levels are not attained or if bleeding is not controlled. Pregnancy & lactation.
Adverse Reactions
Headache, arthralgia, pyrexia, cough. Diarrhea, vomiting, asthenia.
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
10 mL x 1's
Form
Xyntha powd for inj 250 IU
Packing/Price
10 mL x 1's
Form
Xyntha powd for inj 500 IU
Packing/Price
10 mL x 1's
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