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 trialsADYNOVATE is indicated for routine prophylaxis as well as perioperative management in children and adults with hemophilia A. It can be used for:1
ADYNOVATE is not indicated for the treatment of von Willebrand disease.1
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.
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).
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
Adapted from Konkle et al. 2015
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
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
It allows for half-life extension while maintaining the integrity of the ADVATE protein3
It has a long history of use as an extension technology6
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.
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.
See ADYNOVATE bleed control data in children and adults from an on-demand clinical trial
Learn moreLearn what ADYNOVATE patients reported about their experience in a real-world study
See the resultsYou are being directed to ADYNOVATEPro.com. The information
on this website is intended for U.S. healthcare professionals only.