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Healthcare Professionals

FAQs

Frequently Asked Questions

  • WHAT IS THE MOST IMPORTANT INFORMATION I NEED TO KNOW ABOUT ADYNOVATE® [Antihemophilic Factor (Recombinant), PEGylated]?

    Do not attempt to do an infusion to yourself unless you have been taught how by your healthcare provider or hemophilia center.1
    You must carefully follow your healthcare provider’s instructions regarding the dose and schedule for infusing ADYNOVATE so that your treatment will work best for you.1

  • 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 may give you ADYNOVATE when you have surgery. ADYNOVATE can reduce the number of bleeding episodes when used regularly (prophylaxis).1

    ADYNOVATE is not used to treat von Willebrand disease.1

  • WHO SHOULD NOT USE ADYNOVATE?

    You should not use ADYNOVATE if you1:

    • 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.

  • HOW SHOULD I USE ADYNOVATE?

    ADYNOVATE is given directly into the bloodstream.1
    You may infuse ADYNOVATE at a hemophilia treatment center, at your healthcare provider’s office or in your home. You should be trained on how to do infusions by your healthcare provider or hemophilia treatment center. Many people with hemophilia A learn to infuse their ADYNOVATE by themselves or with the help of a family member.1
    Your healthcare provider will tell you how much ADYNOVATE to use based on your individual weight, level of physical activity, the severity of your hemophilia A, and where you are bleeding.1
    Reconstituted product (after mixing dry product with wet diluent) must be used within 3 hours and cannot be stored or refrigerated. Discard any ADYNOVATE left in the vial at the end of your infusion as directed by your healthcare professional.1
    You may have to have blood tests done after getting ADYNOVATE to be sure that your blood level of factor VIII is high enough to clot your blood.1
    Call your healthcare provider right away if your bleeding does not stop after taking ADYNOVATE.1

  • WHAT SHOULD I TELL MY HEALTHCARE PROVIDER BEFORE I USE ADYNOVATE?

    You should tell your healthcare provider if you1:

    • 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 pregnant or planning to 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 ARE THE POSSIBLE SIDE EFFECTS OF ADYNOVATE?

    You can have an allergic reaction to ADYNOVATE.1
    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.1
    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.1

    These are not all the possible side effects with ADYNOVATE. You can ask your healthcare provider for information that is written for healthcare professionals.1

PHARMACOKINETICS

  • WHAT IS HALF-LIFE?

    Half-life describes how long it takes for the body to eliminate half of the dose of a product.18 For example, if the half-life of the product is 8 hours, then 8 hours after dosing, 50% of the dose remains in your bloodstream.

  • HOW DO I FIND OUT MY HALF-LIFE?

    Your pharmacokinetic—or PK, for short—profile impacts your half-life with a product will be. PK is the study of how medications are processed through, and leave the body. Half-life is an important measure of PK because it shows how your body processes factor.18 Your healthcare provider can perform a PK test to find out what your half-life is.19
    A PK test could be helpful in determining what prophylactic regimen may be right for you.19

  • WHY IS IT IMPORTANT TO KNOW MY PK PROFILE?

    Factor levels decline according to half-life.20 And when factor levels are low, bleeds are more likely to occur.21 Since every person processes factor differently, it may be beneficial to know your personal PK profile, including half-life. This way, you can understand how factor levels will change over time, and your healthcare provider can adjust your treatment accordingly.19 Talk to your healthcare provider to see if PK testing is right for you and when it makes sense in your journey.

  • HOW DOES ADYNOVATE EXTEND HALF-LIFE?

    ADYNOVATE is created with a technology called PEGylation.*1 PEGylation has a long history of use as an established technology.11,22 It involves the attachment of polyethylene glycol (PEG) to a drug, which can lengthen the amount of time that the medicine stays in your body. PEGylation was deliberately chosen for the creation of ADYNOVATE because it allows for a half-life extension while maintaining the integrity of the original ADVATE [Antihemophilic Factor (Recombinant)] molecule.1,10 PEG can help slow down the processes your body uses to remove ADYNOVATE over time, helping to ensure that the ADYNOVATE stays in circulation longer.1

    *Proprietary PEGylation Technology exclusively licensed from Nektar Therapeutics.

PROPHYLAXIS

  • WHAT IS PROPHYLAXIS?

    Regular treatment with clotting factor to reduce bleeds is called prophylaxis.21

  • WHY IS IT IMPORTANT TO STICK TO MY PROPHYLAXIS PLAN?

    Your treatment schedule isn’t always going to be the first thing on your mind. However, adherence to your treatment plan is essential. Missing or skipping a dose can cause factor levels to fall too low, which may increase the risk of bleeding.23

    People with hemophilia A have varied lifestyles and unique characteristics. Work with your HCP or HTC to tailor your treatment schedule to fit your personal needs.24

ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] SUPPORT

  • DOES ADYNOVATE HAVE A FREE TRIAL PROGRAM?

    Yes, you may be eligible to receive 8 free trial doses of ADYNOVATE with the FREEDOM OF CHOICE™ trial program.

  • WHAT ABOUT COPAY ASSISTANCE?

    Shire’s CoPay Assistance Program offers financial assistance to eligible patients. If you qualify, you may save up to $12,000 in out-of-pocket medication costs over 12 months on ADYNOVATE or receive reimbursement for your portion of your medication costs.

    †Non-medication expenses, such as ancillary supplies or administration-related costs, are not eligible.

  • HOW DO I KNOW IF MY INSURANCE COVERS ADYNOVATE?

    ADYNOVATE is covered by approximately 85% of managed care plans.2

    ‡As of September 2016

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.