Data from FDA - Curated by Toby Galbraith - Last updated 19 May 2017

Licensing authority

FDA (Food and Drug Administration, USA)

Indication(s)

ADVATE is an Antihemophilic Factor (Recombinant) indicated for:
• Control and prevention of bleeding episodes in adults and children (0-16 years) with Hemophilia A. (1.1)
• Perioperative management in adults and children (0-16 years) with Hemophilia A. (1.2)
• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children (0-16 years) with Hemophilia A. (1.3)

ADVATE is not indicated for the treatment of von Willebrand disease. (1)

Full Prescribing information

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Advisory information

contraindications
Known anaphylaxis to mouse or hamster protein or other constituents of the product. (4)
Special warnings and precautions

• Anaphylaxis and severe hypersensitivity reactions may occur. Patients may develop hypersensitivity to mouse or hamster protein, which is present in trace amounts in the product. Should symptoms occur, discontinue treatment with ADVATE and administer appropriate treatment. (5.1)
• Development of activity-neutralizing antibodies has been detected in patients receiving Factor VIII-containing products, including ADVATE. If expected plasma Factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures Factor VIII inhibitor concentration. (5.2)

Adverse reactions

The serious adverse drug reactions are hypersensitivity and Factor VIII inhibitors. (6.1)
The most common adverse drug reactions observed in ≥ 10% of patients are pyrexia, headache, cough, nasopharyngitis, vomiting, arthralgia, limb injury.(6.1)

Usage information

Dosing and administration

For intravenous use after reconstitution only. (2)

• Each vial of ADVATE contains the labeled amount of recombinant Factor VIII in International Units (IU). (2)

• The required dosage is determined using the following formulas:
Desired increment in Factor VIII concentration (IU/dL or % of normal)=[Total Dose (IU)/body weight (kg) x 2 [IU/dL]/[IU/kg]
OR
Required Dose (IU) = body weight (kg) x Desired Factor VIII Rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL).(2)

• Frequency of intravenous injection of the reconstituted product is determined by the type of bleeding episode and the recommendation of the treating physician. (2.1, 2.2)

• For prophylaxis regimen to prevent or reduce frequency of bleeding episodes, dose between 20 to 40 IU per kg every other day (3 to 4 times weekly). Alternatively, an every third day dosing regimen targeted to maintain FVIII trough levels ≥ 1% may be employed. (2.3)

Use in special populations

• Pregnancy: No human or animal data. Use only if clearly needed. (8.1)
• Pediatric Use: Because clearance (based on per kg body weight) has been demonstrated to be higher in the pediatric population, larger or more frequent dosing based on per kg body weight may be needed in this population. (8.4).

More information

Category Value
Authorisation number BLA125063
Orphan designation No
Product NDC 0944-2921; 0944-2922; 0944-2923; 0944-2924; 0944-2948; 0944-2960; 0944-2961; 0944-2962; 0944-2963; 0944-2964; 0944-2965; 0944-3045; 0944-3046; 0944-3047; 0944-3051; 0944-3052; 0944-3053; 0944-3054
Marketing authorisation holder Baxter Healthcare Corporation