Indications and Limitation 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
*In clinical trials, ADYNOVATE demonstrated the ability to help prevent bleeding episodes using a prophylaxis regimen.
ADYNOVATE has a simple, twice-weekly dosing schedule on the same 2 days each week, which can help personalize treatment so that your patients have more time to spend doing the other things that make them who they are.1
Designed to Extend FVIII Circulation Time
ADYNOVATE is built on the ADVATE® [Antihemophilic Factor (Recombinant)] molecule, a proven treatment in hemophilia A patients. Created with PEGylation technology, ADYNOVATE was designed to stay in circulation longer than ADVATE, to provide factor coverage.†1-3
†Proprietary PEGylation Technology exclusively licensed from Nektar Therapeutics.
CONTRAINDICATIONS: 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).
See Detailed Important Risk Information below.
ADYNOVATE has an established and consistent safety profile across clinical studies1
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.
ADYNOVATE—a treatment that's approved in children and adults with hemophilia A1
ADYNOVATE is not indicated for the treatment of von Willebrand Disease.
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.
Access and resources
Takeda has a variety of resources to help you and your patients navigate access to ADYNOVATE
CONTRAINDICATIONS: 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).
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