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Dosing and Reconstitution

ADVATE^® [Antihemophilic Factor (Recombinant)] Prophylaxis Indicated Dose

Standard regimen: 20-40 IU/kg every 48 hours¹
Pharmacokinetic-driven regimen: 20-80 IU/kg every 72 hours to maintain FVIII trough levels ≥1%¹

BAXJECT III System: Only ADVATE offers the BAXJECT III system, an all-in-one reconstitution system available in 11 different potencies.

Dosing Strengths

ADVATE provides 11 different potencies for single-vial infusions.^1,9

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BAXJECT III^® System

ADVATE offers the the BAXJECT III System, an all-in-one reconstitution system.¹

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Indications and Detailed Important Risk Information for ADVATE [Antihemophilic Factor (Recombinant)].
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Indications

ADVATE is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for:

Control and prevention of bleeding episodes.
Perioperative management.
Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

ADVATE is not indicated for the treatment of von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION

CONTRAINDICATIONS

ADVATE is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster protein or other constituents of the product.

WARNINGS & PRECAUTIONS
Hypersensitivity Reactions

Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with ADVATE. Symptoms include dizziness, paresthesia, rash, flushing, facial swelling, urticaria, dyspnea, pruritus, and vomiting.
Discontinue ADVATE if hypersensitivity symptoms occur and administer appropriate emergency treatment.

Neutralizing Antibodies

Neutralizing antibodies (inhibitors) have been reported following administration of ADVATE predominantly in previously untreated patients (PUPs) and previously minimally treated patients (MTPs). Monitor all patients for the development of factor VIII inhibitors by appropriate clinical observation and laboratory testing. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor VIII inhibitor concentration.

ADVERSE REACTIONS

Serious adverse reactions seen with ADVATE are hypersensitivity reactions, including anaphylaxis, and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.

The most common adverse reactions observed in clinical trials (frequency >5% of subjects) were pyrexia, headache, cough, nasopharyngitis, arthralgia, vomiting, upper respiratory tract infection, limb injury, nasal congestion, and diarrhea.

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Dosing and Reconstitution

Dosing Strengths

BAXJECT III® System

BAXJECT III^® System