ADYNOVATE is an injectable medicine that is used to help treat and control bleeding in children and adults with hemophilia A. ADYNOVATE is not used to treat von Willebrand disease.
People with hemophilia A either don't have enough of, or have improperly working clotting factor VIII. It is believed that ADYNOVATE temporarily replaces the missing factor VIII to help control bleeds.1,2
ADYNOVATE is built on the ADVATE® [Antihemophilic Factor (Recombinant)] molecule, a prescription treatment that was FDA-approved to treat hemophilia A in 2003. However, ADYNOVATE is attached to a molecule called polyethylene glycol, or PEG, which allows it to last longer in the body than ADVATE.†1-3
†Proprietary PEGylation Technology exclusively licensed from Nektar Therapeutics.
SELECTED IMPORTANT RISK INFORMATION
What important information do I need to know about ADYNOVATE and ADVATE?
You can have an allergic reaction to ADYNOVATE or 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.
Do not attempt to infuse yourself with ADYNOVATE or ADVATE unless you have been taught by your HCP or hemophilia center.
See Detailed Important Risk Information below.
Extended Half-Life with ADYNOVATE
What does half-life mean?
Half-life describes how long it takes for the body to eliminate half of the dose of a product.4 For example, if the half-life of a product is 8 hours, then 8 hours after dosing, 50% of the dose remains in your bloodstream.
What is PK?
Pharmacokinetics (or "PK") is the science of how a drug is used up in the body.3 A PK Profile for an individual person helps determine how quickly or slowly a person's body breaks down their treatment.8
Study designs
PK assessment for children under 12 years old
In a phase 3 clinical trial before starting prophylactic treatment with ADYNOVATE, a PK comparison of ADYNOVATE vs ADVATE in 31 children under 12 years old determined there was a 30% to 50% extension in half-life, depending on the lab test used.1,2
PK assessment for adolescents and adults 12 years and older
Before beginning prophylactic treatment with ADYNOVATE, a pharmacokinetic comparison of ADYNOVATE vs ADVATE in 26 patients (adolescents and adults 12 years and older) determined that ADYNOVATE has a 40% to 50% extension in half-life, depending on the lab test used.1,5
PEGylation—specifically chosen for ADYNOVATE
The scientists that developed ADYNOVATE deliberately chose PEGylation Technology† because:6
It allows for a longer half-life while maintaining the integrity of the ADVATE protein2,6
It is a well-established technology
†Proprietary PEGylation Technology exclusively licensed from Nektar Therapeutics.
Study results
ADYNOVATE was designed to stay in your body longer:
In children under 12 years old
in patients under 12 years old ADYNOVATE lasted 30-50% longer than ADVATE2
In adolescents and adults 12 years and older
in patients 12 and older ADYNOVATE lasted 40-50% longer than ADVATE5
Could ADYNOVATE mean 1 less infusion per week for you?
70% of adolescents and adults 12 years and older (69 out of 98) in a clinical study were able to reduce the frequency of prophylaxis dosing from their pre-study prophylaxis dosing regimen by 30% or more, which is approximately 1 fewer infusion per week. Talk to your doctor to learn what this could mean for you.5,7
Talk to your doctor to see if ADYNOVATE is right for you.
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.
See Detailed Important Risk Information below.
Learn more about how ADYNOVATE works to control bleeds
How ADYNOVATE works in your body (11:18)
Putting patients first
Learn how TAKEDA continues to provide product support for ADYNOVATE patients.
Do not use ADYNOVATE if you are allergic to mice or hamster protein or 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.
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What does half-life mean?
In children under 12 years old
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