Bleeding disorders:

Indications for: ADVATE

In patients with Hemophilia A: to control and prevent hemorrhagic episodes, for perioperative management, and routine prophylaxis to prevent or reduce the frequency of hemorrhagic episodes.

Clinical Trials:

Safety and Efficacy Study

Safety and efficacy trial evaluated the pharmacokinetics (double-blinded, randomized, cross-over), safety, immunogenicity, and hemostatic efficacy (open-label) of Advate in 111 patients.

  • The trial included previously treated patients (PTPs with ≥150 exposure days) diagnosed with moderate to severe hemophilia A (FVIII level ≤2% of normal) who were ≥10 years of age.
  • Patients self-administered Advate for routine prophylaxis (≥25 IU/kg body weight 3-4 times per week) and for on-demand treatment of bleeding episodes.
  • A total of 510 bleeding episodes were reported; 439 (86%) were rated excellent or good in their response to treatment with Advate.
  • A total of 411 (81%) bleeding episodes were managed with a single infusion.
  • The rate of new bleeding episodes during the 75-exposure-day prophylactic regimen was calculated as a function of the etiology of bleeding episodes for 107 evaluable patients (n=274 bleeding episodes).
  • The overall rate of new bleeding episodes in the prophylaxis study was 0.52 ± 0.71.

Perioperative Management Study

Safety and efficacy of Advate for perioperative management was investigated in 59 patients (7-65 years old) with severe or moderately severe hemophilia A (factor VIII ≤2%).

  • 57 patients completed the study.
  • Patients received a pre-operative loading dose aimed at increasing the plasma factor VIII level to 60% to 100% of normal for dental procedures or 80% to 120% of normal for all other surgical procedures. 
  • During the surgery, patients received replacement therapy by either bolus or continuous infusion.
  • After discharge, patients continued to receive Advate for control of hemostasis for up to 6 weeks for major orthopedic procedures and up to 2 weeks for all other procedures.
  • Intraoperative efficacy was rated as excellent or good for 61 (93.9%) of the 65 procedures.
  • Postoperative efficacy was rated as excellent or good for 62 (95.4%) of the 65 procedures.

Routine Prophylaxis Study

In a multicenter, open-label, prospective, randomized, controlled postmarketing clinical trial of Advate use in 2 prophylactic treatment regimens compared to that of on-demand treatment, 53 PTPs with severe to moderately severe hemophilia A (FVIII level ≤2 IU/dL) were analyzed in the per-protocol group. 

  • Patients were initially treated for 6 months of on-demand therapy and then randomly assigned to 12 months of either a standard prophylaxis regimen (20-40 IU/kg every 48 hours) or PK-driven prophylaxis regimen (20-80 IU/kg every 72 hours).
  • The median annual bleed rate during the on-demand therapy period was 44 bleeds per patients per year compared with 1 bleed per patient per year while on either prophylaxis regimen, which was a statistically significant difference (P <.0001).
  • 42% of patients experienced no bleeding episodes while on prophylaxis for 1 year.

Adults and Children:

Dosage Required (IU) = Body Weight (kg) × Desired % Factor VIII Increase × 0.5. Infuse over ≤5 minutes (max infusion rate 10mL/min); monitor pulse; if increased significantly, reduce infusion rate or hold. Hemorrhage: Mild: obtain 20–40% FVIII increase; give every 12–24hrs for 1–3 days until resolved. Moderate: obtain 30–60% FVIII increase; give every 12–24hrs for 3 days or until pain or disability resolved. Major: obtain 60–100% FVIII increase; give every 8–24hrs until resolved. Perioperative: Minor: obtain 60–100% FVIII increase; give single bolus infusion within 1 hour of surgery, then every 12–24hrs as needed to control bleeding; Major: pre- and post-op: obtain 80–120% FVIII increase; give 1 dose preoperative to achieve 100% activity, then repeat every 8–24hrs based on healing. Routine prophylaxis: give 20–40 IU/kg every other day (3–4 times weekly). Or, alternatively, an every 3rd day dosing regimen may be followed. Adjust based on response.

ADVATE Contraindications:

Hypersensitivity reactions to mouse or hamster protein or other constituents of the product (mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80, and/or glutathione).

ADVATE Warnings/Precautions:

Not for von Willebrand's disease. Confirm Factor VIII deficiency prior to treatment. Monitor for development of Factor VIII inhibitors. Labor & delivery. Pregnancy (Cat.C). Nursing mothers.

ADVATE Classification:

Clotting factor.

Adverse Reactions:

Pyrexia, headache, cough, nasopharyngitis, arthralgia,
vomiting, upper respiratory tract infection, limb injury, nasal congestion, diarrhea; antibody formation, hypersensitivity reactions.

Drug Elimination:

Half-life: ~12 hours.

Generic Drug Availability:


How Supplied:

Single-dose vial—1 (w. diluent, Baxject II needleless transfer device)