Xyntha

Xyntha

factor viii

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Plasma/albumin-free recombinant coagulation factor VIII
Indications/Uses
Control & prevention of bleeding episodes; routine & surgical prophylaxis in patients w/ hemophilia A (congenital factor VIII deficiency/classic hemophilia). Appropriate for use in childn of all ages including newborns.
Dosage/Direction for Use
IV Individualized dosage. Control of bleeding episodes: Minor (early hemarthrosis, minor muscle/oral bleeds) 20-40 IU/dL infusion every 12-24 hr for at least 1 day, depending on the severity, moderate (bleeding into muscles/oral cavity, mild head trauma) 30-60 IU/dL infusion every 12-24 hr for 3-4 days or until adequate local hemostasis is achieved, major (GI, intracranial, intra-abdominal or intrathoracic bleeding, fractures) 60-100 IU/dL infusion every 8-24 hr until bleeding is resolved. Routine & surgical prophylaxis: Minor surgery 30-60 IU/dL infusion every 12-24 hr for 3-4 days or until adequate local hemostasis is achieved, tooth extraction Single infusion of 30-60 IU/dL plus oral antifibrinolytic therapy w/in 1 hr, major surgery 60-100 IU/dL infusion every 8-24 hr until threat is resolved, or in the case of surgery, until adequate local hemostasis & wound healing are achieved. Prophylaxis Childn <12 yr Recommended starting regimen: 25 ± 5 IU/kg every other day.
Contraindications
Hypersensitivity. History of hypersensitivity to hamster proteins.
Special Precautions
Immediately discontinue use & give appropriate medical management if allergic or anaphylactic reactions occur; inform patients about the early signs of hypersensitivity (including hives, generalized urticaria, chest tightness, wheezing, hypotension) & anaphylaxis. Not indicated in patients w/ von Willebrand's disease. Activity-neutralizing Ab (inhibitors) may develop; monitor for the development of factor VIII inhibitors. Titrate & monitor each patient's factor level in order to ensure an adequate therapeutic response. Pregnancy & lactation. Elderly ≥65 yr.
Adverse Reactions
Factor VIII inhibition (PUPs); headache; cough; arthralgia; pyrexia. Factor VIII inhibition (PTPs); decreased appetite; dizziness; hemorrhage, hematoma; diarrhea, vomiting, abdominal pain, nausea; urticaria, rash, pruritus; myalgia; chills, catheter site related reaction; Ab test +ve, anti-factor VIII Ab +ve, human anti-mouse Ab +ve, abnormal LFT.
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
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Xyntha powd for inj 1000 IU
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1's
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Xyntha powd for inj 2000 IU
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1's
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Xyntha powd for inj 250 IU
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1's
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Xyntha powd for inj 500 IU
Packing/Price
1's
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