Xyntha: Side Effects & Dosing

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing Brand Resources

Concise Prescribing Info

Contents

Moroctocog α (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).

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Dosage/Direction for Use

IV Individualized dosage. Early hemarthrosis, minor muscle/oral bleeds 20-40 IU/dL every 12-24 hr for at least 1 day depending upon the severity of bleeding episode. Moderate bleeding into muscles/oral cavity, mild head trauma 30-60 IU/dL every 12-24 hr for 3-4 days or until adequate local hemostasis is achieved. GI, intracranial, intra-abdominal or intrathoracic bleeding, fractures 60-100 IU/dL every 8-24 hr until bleeding is resolved. Minor operations including tooth extraction 30-60 IU/dL every 12-24 hr for 3-4 days or until adequate local hemostasis is achieved. Tooth extraction 30-60 IU/dL single infusion + oral antifibrinolytic therapy w/in 1 hr. Major operations 60-100 IU/dL every 8-24 hr until threat is resolved, or in case of surgery, until adequate local hemostasis & wound healing are achieved. Routine prophylaxis Adult & adolescents ≥12 yr 30 IU/kg 3x wkly. Childn <12 yr Initially, 25 IU/kg every other day.

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Overdosage

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Contraindications

Patients w/ life-threatening immediate hypersensitivity reactions, including anaphylaxis to moroctocog α & hamster proteins.

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Special Precautions

Discontinue treatment if hypersensitivity symptoms (including hives, generalized urticaria, chest tightness, wheezing, & hypotension) 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 presence of factor VIII inhibitor conc if expected factor VIII activity plasma levels are not attained or if bleeding is not controlled. Pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Headache, arthralgia, pyrexia, cough. Diarrhea, vomiting, asthenia.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Xyntha detailed prescribing information

Storage

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Description

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Action

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MIMS Class

Haemostatics

ATC Classification

B02BD02 - coagulation factor VIII ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.

Thai FDA Category

Presentation/Packing

Form

Xyntha powd for soln for inj 1,000 IU

Packing/Price

10 mL x 1's

Form

Xyntha powd for soln for inj 250 IU

Packing/Price

10 mL x 1's

Form

Xyntha powd for soln for inj 500 IU

Packing/Price

10 mL x 1's

Xyntha

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma