Indications and Limitations of Use: ADYNOVATE® [Antihemophilic factor (Recombinant), PEGylated] is a human antihemophilic factor indicated for use in children and adults with hemophilia A for the control and prevention of bleeding episodes. ADYNOVATE is not indicated for the treatment of von Willebrand disease.1

An established and consistent safety profile across clinical studies1

study design

Pooled safety data evaluation
The safety of ADYNOVATE was evaluated in patients (children and adults) with severe hemophilia A who received at least 1 dose of ADYNOVATE in 3 completed, multicenter, prospective, open-label clinical studies and 4 ongoing clinical studies.1

Additional immunogenicity evaluations
Immunogenicity also evaluated the development of binding IgG and IgM antibodies against factor VIII, PEGylated (PEG)-factor VIII, and PEG and Chinese hamster ovary (CHO) protein.1

  • The majority of patients (238/243) with at least 1 infusion of ADYNOVATE did not develop a persistent binding antibody response to any of these antigens1
  • 13 patients who tested negative at screening developed transient antibodies against factor VIII (n=6) or PEG-FVIII (n=8) at 1 or 2 consecutive study visits1
  • Antibodies were transient and not detectable at subsequent visits1

SELECTED IMPORTANT RISK INFORMATION

WARNINGS & PRECAUTIONS

Neutralizing Antibodies: Formation of neutralizing antibodies (inhibitors) to factor VIII can occur following administration of ADYNOVATE. Monitor patients regularly for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests. Perform an assay that measures factor VIII inhibitor concentration if the plasma factor VIII level fails to increase as expected, or if bleeding is not controlled with expected dose.
See Detailed Important Risk Information below.

study results

Data from 7 clinical trials has shown1

zero Inhibitors Developed in Previously Treated Patients (N=237)†1,2
  • In 191 adult and pediatric previously treated patients who were treated for at least 50 EDs with ADYNOVATE, the factor VIII inhibitor frequency was 0 (95% CI of 0-0.019)‡1
  • One previously untreated patient from an ongoing study, who received at least one infusion of ADYNOVATE, developed neutralizing antibodies to FVIII1

Inhibitors defined as ≥0.6 BU using the Nijmegen modification of the Bethesda assay

Pediatric: <6 years of age with ≥50 EDs, ≥6 to <12 years of age with ≥150 EDs. Adolescent and adult patients: ≥12 years of age with ≥150 prior EDs

EDs=exposure days; IgG=immunoglobulin G; IgM=immunoglobulin M;

SELECTED IMPORTANT RISK INFORMATION

WARNINGS & PRECAUTIONS

Neutralizing Antibodies: Formation of neutralizing antibodies (inhibitors) to factor VIII can occur following administration of ADYNOVATE. Monitor patients regularly for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests. Perform an assay that measures factor VIII inhibitor concentration if the plasma factor VIII level fails to increase as expected, or if bleeding is not controlled with expected dose.
See Detailed Important Risk Information below.

Hypersensitivity reactions

Hypersensitivity reactions are possible with ADYNOVATE. Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with other recombinant antihemophilic factor VIII products, including the parent molecule, ADVATE. Early signs of hypersensitivity reactions that can progress to anaphylaxis may include:1

  • angioedema
  • chest tightness
  • dyspnea
  • wheezing
  • urticaria
  • pruritus

Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur.1

Adverse reactions

The most common adverse reactions (>1% of subjects) reported in the clinical studies were:1

  • Headache
  • Nausea
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