*In clinical trials, ADVATE demonstrated the ability to help patients
prevent bleeding episodes using a prophylaxis regimen.
Not an actual patient.
†
Based on units sold, as of July 2018.
Prophylaxis with ADVATE prevented bleeds 1
• ADVATE can prevent or reduce the frequency of bleeding episodes in children and adults when used prophylactically
• In a multicenter, open-label, prospective, randomized, 2-arm, controlled postmarketing clinical study of the relative efficacy of ADVATE use in 2 prophylactic
treatment regimens compared to that of on-demand treatment. 53 previously treated patients (PTPs) with severe to moderately severe hemophilia A
(FVIII level <2 IU/dL) were analyzed in the per-protocol group. Subjects were initially treated for 6 months of on-demand therapy and then randomized to
12 months of either a standard prophylaxis regimen (20–40 IU/kg every 48 hours) or a PK-driven prophylaxis regimen (20–80 IU/kg every 72 hours)
− 98% reduction in median annualized bleeding rate (ABR) from 44 to 1 when 53 patients in the clinical study switched from on-demand to prophylaxis
− 0 bleeds in 42% (22/53) of patients during 1 year on prophylaxis
ADVATE Important Information
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
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.