Indications and Limitation of Use: ADYNOVATE is indicated for use in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for on-demand treatment and control of bleeding episodes, perioperative management, and routine prophylaxis to reduce the frequency 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: ADYNOVATE is contraindicated in patients who have had 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.

Actual ADYNOVATE patient
Individual results may vary.

Brett, 41 years old

Florida
Golf professional & softball coach
Patient with severe hemophilia A on ADYNOVATE prophylaxis since 2015

My Hemophilia A Story

Growing up watching football with my dad, I searched for sports I could safely participate in, and I fell in love with golf at the age of 8. By the time I turned 18, I had won multiple junior league golf tournaments
I tried different treatments, including ADVATE, before switching to ADYNOVATE
While on ADYNOVATE, I want to stay active and pursue the activities I enjoy
My treatment goal is to strive for zero bleeds
I’m married with 2 kids, and I aspire to be a role model for kids who have hemophilia A

My Experience with ADYNOVATE

I was the ﬁrst person in the US to ﬁll a prescription for ADYNOVATE after its approval in 2015¹
I like the simple dosing regimen of infusing twice a week on the same 2 days, which fits into my busy life¹

The Reasons I Want to Stay on ADYNOVATE

Knowing that Takeda has a legacy as a dedicated, trusted leader in the hemophilia community is important to me. I also appreciate that ADYNOVATE was built on the ADVATE molecule, the most widely used FVIII therapy in the US^1,2*
The simple dosing regimen of ADYNOVATE fits into my busy lifestyle and allows me to personalize my treatment
My hemophilia A does not define me; I continue to embrace what life has to offer

*Based on units sold as of August 2024.

LEARN MORE ABOUT ADYNOVATE

Formation of neutralizing antibodies (inhibitors) to FVIII can occur following administration of ADYNOVATE. Monitor patients regularly for the development of FVIII inhibitors by appropriate clinical observations and laboratory tests.¹

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

Indications and Limitation of Use

ADYNOVATE is indicated in adult and pediatric patients 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

ADYNOVATE is contraindicated in patients who have had 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 patients) reported in the clinical studies were cough, headache, diarrhea, vomiting, rash, nausea, urticaria, and dizziness.

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

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?