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Patients 12 years and older

Pivotal study design in patients 12 years and older

The pivotal phase II/III, multicenter, open-label, nonrandomized study (N=137) evaluated the efficacy, PK, and safety of ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated] twice-weekly prophylaxis vs on-demand treatment, and determined hemostatic efficacy in the treatment of bleeding episodes for 6 months.1

The primary endpoint was to compare the ABR between the prophylactic and on-demand treatment regimens.3

Prophylaxis (40-50 IU/kg, twice-weekly) vs on-demand (10-60 IU/kg) treatment1,3

ABR=annualized bleed rate.

*Treated population=subjects assigned to routine prophylaxis or on-demand treatment with ADYNOVATE and who received at least one dose of the product.

†N=120 in the prophylaxis-arm treated population; one patient received ADVATE® [Antihemophilic Factor (Recombinant)] during initial PK analysis, and was assigned to ADYNOVATE prophylaxis, but did not receive any ADYNOVATE treatment.

‡Per-protocol population=all subjects who were assigned to the prophylactic or the on-demand treatment regimen, treated with their originally assigned dose for the entire duration of study participation and who fulfilled the protocol compliance requirements.

Proven prophylaxis in children and adults (12 years and older)

In the 6-month clinical study: reduction in bleeds when switched from on-demand to prophylaxis.1

SELECTED IMPORTANT RISK INFORMATION

WARNINGS & PRECAUTIONS
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 angioedema, chest tightness, dyspnea, wheezing, urticaria, and pruritus. Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur.

ADVERSE REACTIONS
The most common adverse reactions (≥1% of subjects) reported in the clinical studies were headache and nausea.

Striving toward a goal of zero bleeds with ADYNOVATE® prophylaxis

During the 6-month clinical study in children and adults (12 years and older) receiving twice-weekly prophylaxis treatment1:

ABR=annualized bleed rate; IQR=interquartile range.

Prophylaxis helped some patients stay bleed-free

During the 6-month study in children and adults (12 years and older)1:

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.

Effective bleed control in children and adults (12 years and older)

When bleeds did occur in either study arm, the majority were controlled with a single infusion of ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated].1

In the clinical trial, bleeding episodes controlled:

*Excellent defined as full relief of pain and objective signs of bleeding cessation; Good defined as definite pain relief and/or improvement in signs of bleeding.1

SELECTED IMPORTANT RISK INFORMATION

CONTRAINDICATIONS
ADYNOVATE is contraindicated in patients who have had prior anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE [Antihemophilic Factor (Recombinant)]), mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate 80).

Designed to extend FVIII circulation time

In the adolescent and adult (12 years and older) pivotal study, a PK comparison of ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated] vs ADVATE® [Antihemophilic Factor (Recombinant)] was conducted in 26 subjects prior to initiation of prophylactic treatment with ADYNOVATE.5

The extended terminal half-life of ADYNOVATE was 1.4X–1.5X longer than that of ADVATE (based on one-stage clotting and chromogenic assay, respectively).5

PEGylation Technology* was deliberately chosen because

  • It allows for half-life extension while maintaining the integrity of the ADVATE protein5,6
  • It has a long history of use as an extension technology7

*Proprietary PEGylation Technology exclusively licensed from Nektar Therapeutics.

Detailed Important Risk Information
Prescribing Information (PI)
ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] Important Information
Indications

ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is a human antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for:

  • On-demand treatment and control of bleeding episodes
  • Perioperative management
  • Routine prophylaxis to reduce the frequency of bleeding episodes

Limitation of Use

ADYNOVATE is not indicated for the treatment of von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION


Click here for ADYNOVATE full Prescribing Information.



ADVATE [Antihemophilic Factor (Recombinant)] 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

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.

Click here for ADVATE full Prescribing Information.