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Healthcare Professionals

Efficacy: Under 12 years

Designed to stay in your child’s body 30% to 50% longer2,12

ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated] is the extended half-life product built on ADVATE®.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 was conducted in 31 children prior to beginning prophylactic treatment with ADYNOVATE.12

In the study in children under 12, the extended half-life of ADYNOVATE allowed it to stay in the body 30% to 50% longer than ADVATE [Antihemophilic Factor (Recombinant)] depending on the lab test used.2,12

For representational purposes only. Half-life may vary from person to person. Studies have demonstrated a shorter half-life in children than in adults. Children under 12 years of age may require a dose adjustment or more frequent dosing.1

PEGylation was deliberately chosen for the creation of ADYNOVATE*

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.

Established safety profile in children under 12

Study Design

The pediatric study (N=73) evaluated the efficacy, PK, and safety of ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated] twice-weekly prophylaxis and determined the ability to treat bleeding episodes for 6 months.1,12

Sixty-six children (32 aged <6 years and 34 aged 6 to <12 years) received 40-60 IU/kg of ADYNOVATE prophylactically, twice-weekly.1

Study Goal

The primary goal of the study was to assess development of inhibitors to ADYNOVATE.2

The study met its primary endpoint, as no previously treated children developed inhibitory antibodies to ADYNOVATE.1,2

5 pediatric previously treated patients developed IgG antibodies against PEG-FVIII: transiently (n=2), binding antibodies at the completion of the study (n=2), and developed binding antibodies during the study and positive at completion with decreasing titer (n=1). For all 3 subjects who developed binding antibodies, no conclusion can be drawn whether these antibodies are of transient or persistent nature.1,2

One pediatric previously untreated patient from an ongoing study, who received at least 1 infusion of ADYNOVATE, developed neutralizing antibodies to FVIII.1

*Inhibitors defined as ≥0.6 BU using the Nijmegen modification of the Bethesda assay.2
†From completed and ongoing studies of pediatric previously treated patients.
‡Previously treated patients defined as: <6 years of age with ≥50 exposure days (EDs), ≥6 to <12 years of age with ≥150 EDs.1

SELECTED IMPORTANT RISK INFORMATION

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. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.

Prophylaxis helped some children stay bleed-free

During the 6-month prophylaxis study in children under 12 (N=66)1,12:

SELECTED IMPORTANT RISK INFORMATION

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.

The common side effects of ADYNOVATE are headache and nausea. Tell your healthcare provider about any side effects that bother you or do not go away.

Effective coverage against bleeds

During the 6-month study in children receiving twice-weekly prophylaxis treatment1,12:

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 occurred during the pediatric study, the majority were controlled with a single infusion of ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated].1,12

In the clinical trial, bleeding episodes controlled:

*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

SELECTED IMPORTANT RISK INFORMATION

You should 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 healthcare provider if you are pregnant or breastfeeding because ADYNOVATE may not be right for you.

Detailed Important Risk Information
Prescribing Information (PI)
ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] Important Information
Indications

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 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

You should 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 healthcare provider if you are pregnant or breastfeeding because ADYNOVATE may not be right for you.

You should tell your healthcare provider 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.
  • Have been told that you have inhibitors to factor VIII (because ADYNOVATE may not work for you).

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. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.

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.

The common side effects of ADYNOVATE are headache and nausea. Tell your healthcare provider 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.

Click here for ADYNOVATE full Prescribing Information.



ADVATE [Antihemophilic Factor (Recombinant)] Important Information
Indications

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 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

You should not use ADVATE if you:

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

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

You should tell your healthcare provider 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.
  • Have been told that you have inhibitors to factor VIII (because ADVATE may not work for you).

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. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.

You can have an allergic reaction to ADVATE.
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.

Side effects that have been reported with ADVATE include: cough, headache, joint swelling/aching, sore throat, fever, itching, dizziness, hematoma, abdominal pain, hot flashes, swelling of legs, diarrhea, chills, runny nose/congestion, nausea/vomiting, sweating, and rash.
Tell your healthcare provider 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.

Click here for ADVATE full Prescribing Information.