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

Proven bleed control in children and adults1

In a prophylaxis study, ADYNOVATE controlled a majority of bleeding episodes (n=70) in children under 12 years old, with 1 or 2 infusions1

Graph image - 91.4% of bleeds in children were controlled with 1 or 2 infusions Graph image - 91.4% of bleeds in children were controlled with 1 or 2 infusions

In 90% of bleeding episodes (n=63) treated with ADYNOVATE, control of bleeding was rated as excellent or good†1

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.

SELECTED IMPORTANT RISK INFORMATION

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.

In a prophylaxis study, ADYNOVATE controlled a majority of bleeding episodes (n=591) in children and adults (12 years and older) with 1 or 2 infusions1

Graph image - 96.2% of bleeds in adults were controlled with 1 or 2 infusions Graph image - 96.2% of bleeds in adults were controlled with 1 or 2 infusions

In 95.3% of bleeding episodes (N=591) treated with ADYNOVATE, control of bleeding was rated as excellent or good†1

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.

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.

Meet Brett

Hemophilia A runs in Brett’s family, so it was no surprise when he tested positive for the bleeding disorder right after being born. Growing up under the watchful eye of his parents, Brett liked testing his boundaries. He confesses, “I was a kid who always wanted to do the things that I couldn’t or shouldn’t do.” At age eight, Brett set his sights on becoming a golfer. After speaking with his doctor and his parents, he got the okay to play. But there was one condition: If Brett or anyone he’s playing with thinks that he’s injured, he had to get care immediately. And it turns out, Brett became a pretty good golfer. By the age of 18, he had won 6 Junior League Golf tournaments and traveled all over the world playing.

Today, Brett is a husband and dad who strives for zero bleeds. So when his doctor told him about ADYNOVATE, Brett was very interested. His doctor prescribed infusions on Mondays and Thursdays, which works well in his busy schedule with work and family. So far, on ADYNOVATE, Brett reports he hasn't had a bleed.

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.

Proven bleed control

The efficacy of ADYNOVATE as a prophylaxis was studied in clinical trials

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Personalize patient treatment

ADYNOVATE has a twice-weekly dosing regimen that you can tailor to each patient

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