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

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

Graphic showing 91.4% of bleeding episodes (n=70) 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

Graphic showing 96.2% of bleeding episodes (n=591) 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, including anaphylaxis, have been reported with ADYNOVATE. Hypersensitivity reactions that can progress to anaphylaxis may include angioedema, chest tightness, dyspnea, wheezing, urticaria, pruritus, and nausea and vomiting. 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.

Brett: actual patient

ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] Important Information

Indications and Limitation of Use

ADYNOVATE 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

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

DETAILED 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).

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.

ADVERSE REACTIONS

The most common adverse reactions (≥1% of subjects) reported in the clinical studies were headache, diarrhea, rash, nausea, dizziness and urticaria.

Click here for ADYNOVATE Prescribing Information.
Click here for ADYNOVATE Prescribing Information en Español.

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

CONTRAINDICATIONS

Patients who have life-threatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster protein or other constituents of the product.

WARNINGS & PRECAUTIONS

Hypersensitivity Reactions: Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with ADVATE. Symptoms include dizziness, paresthesia, rash, flushing, facial swelling, urticaria, dyspnea, pruritus, and vomiting. Discontinue ADVATE if hypersensitivity symptoms occur and administer appropriate emergency treatment.

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.

ADVERSE REACTIONS

Serious adverse reactions seen with ADVATE are hypersensitivity reactions, including anaphylaxis, and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.
The most common adverse reactions observed in clinical trials (>5% of subjects) were pyrexia, headache, cough, nasopharyngitis, arthralgia, vomiting, upper respiratory tract infection, limb injury, nasal congestion, and diarrhea.

Click here for ADVATE Prescribing Information.
Click here for ADVATE Prescribing Information en Español.

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

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

SELECTED IMPORTANT RISK INFORMATION

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

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

SELECTED IMPORTANT RISK INFORMATION

WARNINGS & PRECAUTIONS

Meet Brett

Patient profile: Norwood—looking for adequate bleed coverage

Are you a U.S. healthcare professional?

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

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

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

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

Are you a U.S. healthcare
professional?