dcsimg
For Healthcare ProfessionalsIntended for US Audiences

Safety

A low risk of inhibitor development in previously treated patients (PTPs)*4-8

-0.00%0.01%0.02%0.03%0.04%0.05%0.06%0.07%0.08%0.09%0.10%0.11%0.12%0.13%0.14%0.15%0.16%0.17%0.18%0.19%0.20%0.21%0.22%0.23%0.24%0.25%0.26%0.27%0.28%0.29%0.30%0.31%0.32%0.33%0.34%0.35%0.36%0.37%0.38%0.39%0.40%41%42%43%44%45%46%47%48%49%50%51%52%53%54%55%56%57%58%59%60%61%62%63%64%65%66%67%68%69%70%71%72%73%74%75%76%77%78%79%80%81%82%83%84%85%86%87%88%89%90%91%92%93%94%95%96%97%98%99%100%
Incidence of inhibitors
ADVATE [Antihemophilic Factor (Recombinant)] in 6 clinical studies, 270 patients had a .37% incidence of inhibitors. (95% confidence interval, 0.02% - 2.13%)
Learn about the safety profile of ADVATE [Antihemophilic Factor (Recombinant)]: 1 low-titer, nonpersistent inhibitor (<1%) in the pivotal study (n=108)  ref a, b, 6 0 inhibitors in a continuation study (n=82)  ref a, b, 5 0 inhibitors in a pediatric study (n=53)  ref c, 8 0 inhibitors in a surgery study (n=59)  ref a, b, 7 0 inhibitors in a Japanese study (n=15)  ref 5 0 inhibitors in a prophylaxis study (n=73)  ref a, d, 4

*PTPs are considered to be the most appropriate study population for the assessment of product-related immunogenicity.13 Six clinical studies of 270 PTPs with moderately severe to severe hemophilia A demonstrated a low inhibitor rate of 0.37%.4-8

aPatients with an estimated ≤150 factor VIII exposure days.4,6,7

bSome patients participated in more than 1 study.5

cPatients with an estimated ≤50 factor VIII exposure days.8

dThere was 1 case of a possible low-titer factor VIII inhibitor, which was unconfirmed, unaccompanied by symptoms of inhibitor presence, and disappeared at the subject’s subsequent test.4