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Efficacy

In a multicenter, open-label, prospective, randomized, 2-arm, controlled postmarketing clinical study of the relative efficacy of ADVATE® [Antihemophilic Factor (Recombinant)] 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 pharmacokinetic-driven prophylaxis regimen (20-80 IU/kg every 72 hours).1

ABRs for the 2 prophylaxis regimens were comparable.1

ADVATE prophylaxis prevented bleeds

-0%1%2%3%4%5%6%7%8%9%10%11%12%13%14%15%16%17%18%19%20%21%22%23%24%25%26%27%28%29%30%31%32%33%34%35%36%37%38%39%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%
of patients

experienced zero bleeds
during 1 year on prophylaxis1

(n=22 in the per-protocol group of 53)

ADVATE prophylaxis may help your patients prevent or reduce the frequency of bleeds

Significant reduction in median ABR with prophylactic treatment compared with on-demand treatment1

  • 97% reduction in joint bleeds from 38.7 to 1 median joint ABR after switching from on-demand to prophylaxis1

Reduction in bleeds when switched
from on-demand to prophylaxis1,2

Reduction in bleeds when switched from on-demand to prophylaxis with ADVATE [Antihemophilic Factor (Recombinant)]: 44 bleeds (IQR, 20.8) reduced to 1 bleed (IQR, 4.1), resulting in a 98% reduction in bleeds.

Low median ABR across bleeding types while
on prophylaxis (N=53)1,2

Low median ABR across bleeding types while on prophylaxis (N=53) with ADVATE [Antihemophilic Factor (Recombinant)]: 0 to 1 ABR depending on type of bleed.

SELECTED IMPORTANT RISK INFORMATION

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.

Neutralizing Antibodies

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.

After 12 months of prophylactic treatment with ADVATE, improvements in physical health-related quality of life and overall Physical Component Score were seen based on changes in1,9,10:

  • Bodily Pain: Statistically significant improvements in the amount of pain experienced by a patient and how much pain interferes with normal work
  • Role Physical: Clinically meaningful improvements in this physical health-related quality of life measure.

Clinically meaningful changes were not seen in1:

  • The physical health-related sub-categories of General Health and Physical Functioning
  • The mental health-related component score and sub-categories of Mental Health, Role Emotional, Social Functioning, and Vitality
Physical Component Score Findings: Bodily Pain: reduced levels of pain and improvements in the limitations of work due to pain Physical Functioning: changes not observed in limitations to a range of minor and major physical activities General Health: changes not observed in the views and expectations of overall health Role Physical: clinically meaningful improvements in the ability to perform work or other daily activities
Physical Component Score Findings: Bodily Pain: reduced levels of pain and improvements in the limitations of work due to pain Physical Functioning: changes not observed in limitations to a range of minor and major physical activities General Health: changes not observed in the views and expectations of overall health Role Physical: clinically meaningful improvements in the ability to perform work or other daily activities

SELECTED IMPORTANT RISK INFORMATION

ADVERSE REACTIONS

Serious adverse reactions seen with ADVATE are hypersensitivity reactions, including anaphylaxis, and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.

The most common adverse reactions observed in clinical trials (frequency >5% of subjects) were pyrexia, headache, cough, nasopharyngitis, arthralgia, vomiting, upper respiratory tract infection, limb injury, nasal congestion, and diarrhea.