Hemophilia A Drug Safety & Tolerance

No Inhibitors in Previously Treated Patients (PTPs) with Hemophilia A Treated with wilate1

  • Immune system antibody response (immunogenicity) was assessed in a pooled analysis that selected from 136 previously treated patients (PTPs) across 5 clinical studies. 83 subjects fulfilled study criteria:
    • At least 150 exposure days at the time of enrollment in clinical study
    • Treated for at least 50 exposure days and 6 months
  • Development of inhibitors in the immune system can block the effectiveness of many medications. No patient developed inhibitors to wilate.
  • Rate of inhibitor development was 0% (95% CI, 0-4.35%)

No Serious Systemic Adverse Drug Reactions Were Reported1

  • 136 previously treated patients (PTPs) with hemophilia A (aged 11 to 66 years) received wilate in 5 clinical studies that involved prophylactic (preventive) use, on-demand treatment, surgery and/or pharmacokinetics (the processing of drugs within the body)
  • Subjects received over 19 million units of wilate during 9,001 exposure days
  • The most common adverse reaction was pyrexia (fever) (2 subjects; 1.5%). Other adverse reactions included pruritus (itchy skin), headache and sleeping disorder. The most serious adverse reactions to treatment with wilate are hypersensitivity reactions (immune system reactions such as allergies and autoimmunity).
  • Two subjects in the pivotal study had transient (short-lived) worsening of pre-existing thrombocytosis (over-production of platelets) while on the study, that remains unexplained
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Review wilate usage in the treatment of hemophilia A, including dosage and administration, vial sizes and storage

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References:
  1. wilate Full Prescribing Information. Hoboken, NJ: Octapharma; rev September 2019.