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

Inhibitor development in PUPs with hemophilia A

FVIII inhibitors typically develop following FVIII-replacement treatment, including plasma-derived products, in ~30% of PUPs^2-10

The development of FVIII inhibitors results in serious treatment complications, such as more frequent bleeding (including life-threatening bleeds), which can cause the management of bleeds to become challenging¹¹
Genetics, family history, and environmental factors play a role in inhibitor development, with several mutations identified as being associated with increased inhibitor risk¹²

A prospective global registry* tracking newly diagnosed hemophilia A patients (N=1038) found⁸:

97% of inhibitors develop within 50 days, with 79% occurring in the first 20 days of treatment.⁸

Chart showing inhibitor development in PUPs: 79% within 20 exposure days, 18% within 21-50 exposure days, and 3% within 51-75 exposure days.

*Aiming to define the risk periods for inhibitor development until 1000 EDs.⁸
ED=exposure day.

Study results

A low inhibitor development rate of 11% was observed in the ADYNOVATE PUP Study¹

From the completed study in 120 PUPs with severe hemophilia A

patients were evaluable for inhibitor development¹*

patients developed FVIII inhibitors associated with ADYNOVATE treatment

After mean (SD) exposure days of 7.6 (4)¹

patients did not develop FVIII inhibitors¹

*The remaining 20 patients had <100 EDs when they discontinued or completed the analysis and therefore were not included in the evaluation.¹³

Of the 11 patients who developed FVIII inhibitors, 6 developed high-titer inhibitors (>5 Bethesda Units), and 5 developed low-titer inhibitors (≤5 Bethesda Units).¹

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

STUDY DESCRIPTION

A prospective, multicenter, Phase 3, open-label trial evaluated ADYNOVATE in 120 previously untreated pediatric patients (<6 years, severe hemophilia A, FVIII <1%)^1,14
Eligible patients had ≤2 prior FVIII exposure days and no inhibitors at enrollment¹⁴
Participants received either prophylaxis or on-demand therapy¹⁴
Immunogenicity was evaluated by monitoring neutralizing (inhibitory) antibodies to FVIII and by measuring the development of binding IgG and IgM antibodies against factor VIII, PEGylated (PEG)-factor VIII, and PEG using validated ELISA assays^1,14
Treatment continued for ≥100 exposure days or until inhibitor development¹⁴
The study spanned 55 sites in 19 countries, with data collected on demographics and eligibility: White (50.8%), Asian (37.5%), Black or African American (5.8%), Hispanic or Latino (5%), multiple races (3.3%), other races (2.5%)¹³
The study began in November 2015, with the final database lock in December 2024¹³

STUDY OBJECTIVE

To investigate the safety, immunogenicity, and hemostatic efficacy of ADYNOVATE with the incidence of FVIII inhibitor development as primary outcome¹⁴

ELISA=enzyme-linked immunosorbent assay; IgG=immunoglobulin G;
IgM=immunoglobulin M; SD=standard deviation.

When it comes to a low inhibitor development rate (11% in a clinical study) and bleed control, choose ADYNOVATE for your PUPs’ on-demand needs¹

Hypothetical patient
Individual results may vary.

Noah, 3 years old

Houston, TX
Pre-kindergarten
Severe hemophilia A on non-factor prophylaxis

My child’s hemophilia A story

Shortly after birth, our doctor prescribed my son a non-factor prophylaxis therapy
Recently, he fell at the playground and injured his knee, resulting in a bleed that required FVIII infusion. Our HCP administered ADYNOVATE to control the bleed
We discussed FVIII options with our HCP, who highlighted the potential risk of developing an inhibitor, which could complicate treatment
Following this incident, we decided to continue using ADYNOVATE for on-demand and surgery needs, including any emergency visits and future surgeries, such as the possible tonsillectomy and tooth extraction mentioned by his HCP

Treatment considerations from Noah’s HCP

ADYNOVATE is a full-length recombinant FVIII protein with an extended terminal half-life, lasting longer in the body than standard half-life FVIII products^1,15
ADYNOVATE's efficacy and safety profile has been proven in clinical studies and is supported by real-world experience for the past 10 years¹
In a study with patients who hadn’t received FVIII treatment before, ADYNOVATE:
- Had a low rate of inhibitor development (11%)¹

Why did Noah’s HCP choose ADYNOVATE?

When it comes to a low inhibitor development rate (11% in a clinical study) and bleed control, choose ADYNOVATE for your PUPs’ on-demand needs¹

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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

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.

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.

Inhibitor development in PUPs with hemophilia A

FVIII inhibitors typically develop following FVIII-replacement treatment, including plasma-derived products, in ~30% of PUPs2-10

97% of inhibitors develop within 50 days, with 79% occurring in the first 20 days of treatment.8

Study results

When it comes to a low inhibitor development rate (11% in a clinical study) and bleed control, choose ADYNOVATE for your PUPs’ on-demand needs1

Are you a U.S. healthcare professional?

FVIII inhibitors typically develop following FVIII-replacement treatment, including plasma-derived products, in ~30% of PUPs^2-10

97% of inhibitors develop within 50 days, with 79% occurring in the first 20 days of treatment.⁸

When it comes to a low inhibitor development rate (11% in a clinical study) and bleed control, choose ADYNOVATE for your PUPs’ on-demand needs¹

Are you a U.S. healthcare
professional?