ADYNOVATE: Striving to meet the treatment needs of hemophilia A patients

ADYNOVATE is a full-length recombinant FVIII protein with an extended terminal half-life.1

ADYNOVATE is built on the ADVATE® [Antihemophilic Factor (Recombinant)] molecule, a proven treatment in hemophilia A patients. ADYNOVATE was designed to extend the circulation time of FVIII and has an established and consistent safety profile.1-3

Learn about safety data from the ADYNOVATE clinical trials

Treatment that can be personalized to work with your patients' needs1

Simple, twice-weekly dosing schedule given on the same 2 days every week.1

ADYNOVATE is indicated for routine prophylaxis as well as perioperative management in children and adults with hemophilia A. It can be used for:1

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

ADYNOVATE is not indicated for the treatment of von Willebrand disease.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.
See Detailed Important Risk Information below.

How does ADYNOVATE work?

ADYNOVATE is believed to help control bleeding by temporally replacing the missing factor VIII needed for effective hemostasis.1

Watch the Mechanism of Action video to learn more (length: 8:00).

Designed to extend FVIII circulation time

The extended terminal half-life of ADYNOVATE was 1.4X–1.5X longer than that of ADVATE in adolescents and adults 12 years and older (based on one-stage clotting and chromogenetic assay, respectively).4

Median FVIII Activity as Determined by One-Stage Clotting Assay4

Graph of Median FVIII Activity.

Adapted from Konkle et al. 2015

Pharmacokinetic (PK) analysis

In the adolescent and adult (12 years and older) pivotal study, a PK comparison of ADYNOVATE vs ADVATE was conducted in 26 patients prior to initiation of prophylactic treatment with ADYNOVATE.4

PK analysis in children <12 years old

In the pediatric phase 3, prospective, uncontrolled, multicenter, open-label study, a PK comparison of ADYNOVATE vs ADVATE was conducted in 31 children less than 12 years old prior to initiation of prophylactic treatment with ADYNOVATE.5 This analysis demonstrated higher clearance, a shorter half-life, and lower incremental recovery of factor VIII compared to patients 12 years and older. Because clearance (based on per kg body weight) has been demonstrated to be higher in children (<12 years), dose adjustment or more frequent dosing based on per kg body weight may be needed in this population.1

PEGylation Technology was deliberately chosen because4,5

PEGylation is the covalent attachment of a polyethylene glycol polymer, called PEG, to a drug or protein.1,6

Proprietary PEGylation Technology exclusively licensed from Nektar Therapeutics.

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.
See Detailed Important Risk Information below.

Helping with on-demand needs

See ADYNOVATE bleed control data in children and adults from an on-demand clinical trial

Learn more
Real-world outcomes

Learn what ADYNOVATE patients reported about their experience in a real-world study

See the results