* 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 .