Indication: 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.
Proven perioperative bleed control
ADVATE is indicated for surgical use and can be used before, during, and after a procedure depending on the type.1
Perioperative study design1,2
In a multicenter, prospective, open-label, uncontrolled study evaluating the efficacy and safety of ADVATE for perioperative management, a total of 65 procedures were performed in 58 patients with severe or moderately severe hemophilia A (factor VIII ≤2%). Patients were between the ages of 7 to 65 years of age (3 were 7 to <13, 6 were 13 to <16, and 50 were ≥16).‡
Perioperative FVIII loading doses1
Patients received a preoperative loading dose aimed at increasing the plasma FVIII level to 60% to 100% of normal for dental procedures or 80% to 120% of normal for all other surgical procedures.
Intraoperative ADVATE infusions1,2
During the surgery, patients received replacement therapy by either bolus (47 procedures) or continuous infusion (18 procedures). In 18 procedures, ADVATE was given either by continuous infusion alone, or a combination of continuous infusion and bolus infusion; all were classified as continuous infusion for the purpose of analysis. For continuous infusion, the initial rate was 4 IU/kg/hour for patients >12 years of age and 5 IU/kg/hour for patients 5 to 12 years of age.
Treatment continuity1
In the study examining perioperative management, after discharge patients continued to receive ADVATE for control of hemostasis as prescribed by the investigator for up to 6 weeks for major orthopedic procedures and up to 2 weeks for all other procedures.
‡The disparity in patient totals between those counted and those treated was due to one patient electing not to undergo planned surgery.
Selected Important Risk Information
Warnings & Precautions
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.
Please see additional detailed important risk information below.
Hemostatic efficacy in most minor and major surgeries was rated excellent or good†1
93.9% of intraoperative procedures were rated excellent or good.†
The rating was not done for 3 procedures and is unknown for 1 procedure.1
95.4% of postoperative procedures were rated excellent or good.†
The rating was not done for 1 procedure and is unknown for 2 procedures.1†EXCELLENT: intraoperative blood loss was less than expected for the type of procedure performed. GOOD: intraoperative blood loss was as expected for the type of procedure performed.
Studied in a range of surgical procedures1
| Surgery classification | Number of procedures | Number of patients |
|---|---|---|
| Major§ | 22 | 22 |
| Minor | 35 | 28 |
| Dental | 8 | 8 |
§Included intracranial, intra-abdominal, intrathoracic, or joint replacement surgery.
IMPORTANT RISK INFORMATION
