Efficacy: 12 years and older

Designed to stay in your body 40% to 50% longer16

ADYNOVATE® is the extended half-life product built on ADVATE® [Antihemophilic Factor (Recombinant)].1

Half-life refers to how long it takes for the body to eliminate half the dose of a product.13

A pharmacokinetic comparison of ADYNOVATE vs ADVATE® [Antihemophilic Factor (Recombinant)] was conducted in 26 adolescents and adults (12 years and older) prior to beginning prophylactic treatment with ADYNOVATE.16

In the study in adolescents and adults (12 years and older), the extended half-life of ADYNOVATE allowed it to stay in the body 40% to 50% longer than ADVATE [Antihemophilic Factor (Recombinant)] depending on the lab test used.16
In the study in adolescents and adults (12 years and older), the extended half-life of ADYNOVATE allowed it to stay in the body 40% to 50% longer than ADVATE [Antihemophilic Factor (Recombinant)] depending on the lab test used.

For representational purposes only. Half-life may vary from person to person.

PEGylation was deliberately chosen for the creation of ADYNOVATE*16

Polyethylene glycol, or PEG, is attached to the full-length ADVATE molecule in a process called PEGylation.1

  • It extends the half-life of ADVATE1

*Proprietary PEGylation Technology exclusively licensed from Nektar Therapeutics.

Twice-weekly prophylaxis was proven to reduce ABR

Study Design

The safety, efficacy, and PK of ADYNOVATE® were evaluated in a 6-month study that compared the efficacy of a twice-weekly prophylactic treatment regimen with on-demand treatment and determined hemostatic efficacy in the treatment of bleeding episodes.1

A total of 137 previously treated male patients (12 to 65 years old) with severe hemophilia A received at least 1 infusion with ADYNOVATE. Twenty-five of the 137 subjects were adolescents (12 to less than 18 years of age).1

Adolescents and adults (12 years and older) in this study were given ADYNOVATE prophylaxis twice-weekly at a dose of 40-50 IU/kg (n=120) or on-demand treatment (n=17) with ADYNOVATE at a dose of 10-60 IU/kg.1

Study Goal

The primary study goal was to compare the ABR between the prophylaxis versus on-demand treatment groups.2

95% reduction in median overall ABR.41.5% median ABR with on-deman treatment Vs 1.9% median ABR with prophylactic treatment.

Prophylaxis helped some patients stay bleed-free

During the 6-month study in adolescents and adults (12 years and older)1:

40% (n=40) experienced zero total bleeds. 57% (n=68) experienced zero joint bleeds. 57% (n=68) experienced zero spontaneous bleeds.

Per-protocol population consisted of all patients who were assigned to the prophylactic group treated with their originally assigned dose for the entire duration of study participation and who fulfilled the protocol compliance requirements.

Effective coverage against bleeds

During the 6-month clinical study in adolescents and adults (12 years and older) receiving twice-weekly prophylaxis treatment1:

Zero median ABR for join & spontaneous. Joint: Prophylaxis 0.0 (IQR: 2.0) Median ABR vs. On-demand 38.1 (IQR: 20.1) median ABR. Spontaneous: Prohylaxis 0.0 (IQR: 2.2) median ABR vs on-demand 21.6 (IQR: 22.0) median ABR. Zero median ABR for join & spontaneous. Joint: Prophylaxis 0.0 (IQR: 2.0) Median ABR vs. On-demand 38.1 (IQR: 20.1) median ABR. Spontaneous: Prohylaxis 0.0 (IQR: 2.2) median ABR vs on-demand 21.6 (IQR: 22.0) median ABR.

Median is defined as the middle number in a list of numbers arranged in numerical order.14
ABR=annualized bleed rate, the number of bleeds that occur over a year.
IQR=interquartile range; the range of values of the variable in a statistical distribution that lies between the upper and lower quartiles.15

Effective bleed control when you need it

When bleeds did occur, the majority were controlled with a single infusion of ADYNOVATE®.1

In the clinical trial, bleeding episodes controlled:

96.2% of all bleeding episodes (n=591) controlled with 1 or 2 infusions. 85.4 (n=505) with 1 infusion. 10.8% (n=64) with 2 infusions. 3.8% (n=22) with over 3 infusions In 95.3% of bleeding episodes (n=591) treated with Adynovate, control of bleeding was rated as excellent or good.

*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.1

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

What is ADYNOVATE?

  • ADYNOVATE is an injectable medicine that is used to help treat and control bleeding in children and adults with hemophilia A (congenital Factor VIII deficiency).

ADYNOVATE is not used to treat von Willebrand disease.

SELECTED IMPORTANT RISK INFORMATION

Who should not use ADYNOVATE?

Do not use ADYNOVATE if you:

  • Are allergic to mice or hamster protein
  • Are allergic to any ingredients in ADYNOVATE or ADVATE [Antihemophilic Factor (Recombinant)]

Tell your HCP if you are pregnant or breastfeeding because ADYNOVATE may not be right for you.

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

What is ADYNOVATE?

  • ADYNOVATE is an injectable medicine that is used to help treat and control bleeding in children and adults with hemophilia A (congenital Factor VIII deficiency).
  • Your healthcare provider (HCP) may give you ADYNOVATE when you have surgery.
  • ADYNOVATE can reduce the number of bleeding episodes when used regularly (prophylaxis).

ADYNOVATE is not used to treat von Willebrand disease.

SELECTED IMPORTANT RISK INFORMATION

Who should not use ADYNOVATE?

Do not use ADYNOVATE if you:

  • Are allergic to mice or hamster protein
  • Are allergic to any ingredients in ADYNOVATE or ADVATE [Antihemophilic Factor (Recombinant)]

Tell your HCP if you are pregnant or breastfeeding because ADYNOVATE may not be right for you.

ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] Important Information
What is ADYNOVATE?
  • ADYNOVATE is an injectable medicine that is used to help treat and control bleeding in children and adults with hemophilia A (congenital Factor VIII deficiency).
  • Your healthcare provider (HCP) may give you ADYNOVATE when you have surgery.
  • ADYNOVATE can reduce the number of bleeding episodes when used regularly (prophylaxis).

ADYNOVATE is not used to treat von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION
Who should not use ADYNOVATE:

Do not use ADYNOVATE if you:

  • Are allergic to mice or hamster protein
  • Are allergic to any ingredients in ADYNOVATE or ADVATE [Antihemophilic Factor (Recombinant)]

Tell your HCP if you are pregnant or breastfeeding because ADYNOVATE may not be right for you.

What should I tell my HCP before using ADYNOVATE?

Tell your HCP if you:

  • Have or have had any medical problems.
  • Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies.
  • Have any allergies, including allergies to mice or hamsters.
  • Are breastfeeding. It is not known if ADYNOVATE passes into your milk and if it can harm your baby.
  • Are or become pregnant. It is not known if ADYNOVATE may harm your unborn baby.
  • Have been told that you have inhibitors to factor VIII (because ADYNOVATE may not work for you).
What important information do I need to know about ADYNOVATE?
  • You can have an allergic reaction to ADYNOVATE. Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.
  • Do not attempt to infuse yourself with ADYNOVATE unless you have been taught by your HCP or hemophilia center.
What else should I know about ADYNOVATE and Hemophilia A?
  • Your body may form inhibitors to factor VIII. An inhibitor is part of the body’s normal defense system. If you form inhibitors, it may stop ADYNOVATE from working properly. Talk with your HCP to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.
What are possible side effects of ADYNOVATE?
  • The common side effects of ADYNOVATE are headache and nausea. These are not all the possible side effects with ADYNOVATE. Tell your HCP about any side effects that bother you or do not go away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For additional safety information, click here for ADYNOVATE Full Prescribing Information and discuss with your HCP.



ADVATE [Antihemophilic Factor (Recombinant)] Important Information
What is ADVATE?
  • ADVATE is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called "classic" hemophilia).
  • ADVATE is used to prevent and control bleeding in adults and children (0-16 years) with hemophilia A. Your healthcare provider (HCP) may give you ADVATE when you have surgery.
  • ADVATE can reduce the number of bleeding episodes in adults and children (0-16 years) when used regularly (prophylaxis).

ADVATE is not used to treat von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION
Who should not use ADVATE?

Do not use ADVATE if you:

  • Are allergic to mice or hamsters.
  • Are allergic to any ingredients in ADVATE.

Tell your HCP if you are pregnant or breastfeeding because ADVATE may not be right for you.

What should I tell my HCP before using ADVATE?

Tell your HCP if you:

  • Have or have had any medical problems.
  • Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies.
  • Have any allergies, including allergies to mice or hamsters.
  • Are breastfeeding. It is not known if ADVATE passes into your milk and if it can harm your baby.
  • Are or become pregnant. It is not known if ADVATE may harm your unborn baby.
  • Have been told that you have inhibitors to factor VIII (because ADVATE may not work for you).
What important information do I need to know about ADVATE?
  • You can have an allergic reaction to ADVATE. Call your HCP right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.
  • Do not attempt to infuse yourself with ADVATE unless you have been taught by your HCP or hemophilia center.
What else should I know about ADVATE and Hemophilia A?
  • Your body may form inhibitors to factor VIII. An inhibitor is part of the body’s normal defense system. If you form inhibitors, it may stop ADVATE from working properly. Talk with your HCP to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.
What are possible side effects of ADVATE?
  • Side effects that have been reported with ADVATE include: cough, headache, joint swelling/aching, sore throat, fever, itching, unusual taste, dizziness, hematoma, abdominal pain, hot flashes, swelling of legs, diarrhea, chills, runny nose/congestion, nausea/vomiting, sweating, and rash. Tell your HCP about any side effects that bother you or do not go away or if your bleeding does not stop after taking ADVATE.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For additional safety information, click here for ADVATE Prescribing Information and discuss with your HCP.