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ADYNOVATE (antihemophilic factor- recombinant pegylated kit


  1. Patient Information
  2. What Is The Most Important Information I Need To Know About Adynovate?
  3. What Is Adynovate?
  4. You Should Not Use Adynovate If You:
  5. How Should I Use Adynovate?
  6. You Should Tell Your Healthcare Provider If You:
  7. What Are The Possible Side Effects Of Adynovate?
  8. What Are The Adynovate Dosage Strengths?
  9. How Do I Store Adynovate?
  10. What Else Should I Know About Adynovate And Hemophilia A?
  11. Advise Patients To:

Patient Information 

ADYNOVATE
[Antihemophilic Factor (Recombinant), PEGylated]

This leaflet summarizes important information about ADYNOVATE. Please read it carefully before using this medicine. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about ADYNOVATE. If you have any questions after reading this, ask your healthcare provider.

What Is The Most Important Information I Need To Know About Adynovate? 

Do not attempt to do an infusion to yourself unless you have been taught how by your healthcare provider or hemophilia center.

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.

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).

ADYNOVATE is not used to treat von Willebrand disease.

You Should Not Use Adynovate If You: 

  • Are allergic to mice or hamster protein
  • Are allergic to any ingredients in ADYNOVATE or ADVATE

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.

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.

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.

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.

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.

Call your healthcare provider right away if your bleeding does not stop after taking ADYNOVATE.

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.
  • 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.

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.

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

What Are The Adynovate Dosage Strengths? 

ADYNOVATE comes in seven different dosage strengths: 250 International Units (IU), 500 IU, 750 IU, 1000 IU, 1500 IU, 2000 IU*, and 3000 IU*. The actual strength will be imprinted on the label and on the box. The seven different strengths are color coded, as follows:

Figure

Dosage strength of approximately 250 International Units per vial

Figure

Dosage strength of approximately 500 International Units per vial

Figure

Dosage strength of approximately 750 International Units per vial

Figure

Dosage strength of approximately 1000 International Units per vial

Figure

Dosage strength of approximately 1500 International Units per vial

Figure

Dosage strength of approximately 2000 International Units per vial
(*available only with 5 mL Sterile Water for Injection)

Figure

Dosage strength of approximately 3000 International Units per vial
(*available only with 5 mL Sterile Water for Injection)

Always check the actual dosage strength printed on the label to make sure you are using the strength prescribed by your healthcare provider. Always check the expiration date printed on the box. Do not use the product after the expiration date printed on the box.

How Do I Store Adynovate? 

  • Do not freeze.
  • Store at refrigerated temperature 2 C to 8 C (36 F to 46 F).
  • May store at room temperature not to exceed 30 C (86 F) for up to 3 months.
    • Write the date on the carton when ADYNOVATE is removed from refrigeration.
    • After storage at room temperature, do not return product back to the refrigerator.
  • Do not use beyond the expiration date printed on the carton or vial.
  • Store vials in their original box and protect them from extreme exposure to light.

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

Medicines are sometimes prescribed for purposes other than those listed here. Do not use ADYNOVATE for a condition for which it is not prescribed. Do not share ADYNOVATE with other people, even if they have the same symptoms that you have.

Baxalta, Advate, Adynovate, and Baxject are trademarks of Baxalta Incorporated.

Baxalta US Inc.
Westlake Village, CA 91362 USA
U.S. License No. 2020
Issued 03/2017

16J050-ADY-US

Advise Patients To: 

  • Read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • Call their healthcare provider or go to the emergency department right away if a hypersensitivity reaction occurs. Early signs of hypersensitivity reactions may include rash, hives, itching, facial swelling, tightness of the chest, and wheezing. Advise patients to discontinue use of the product if these symptoms occur and seek immediate emergency treatment.
  • Contact their healthcare provider or treatment facility for further treatment and/or assessment if they experience a lack of a clinical response to factor VIII therapy because this may be a sign of inhibitor development.
  • Advise patients to consult with their physicians or healthcare provider prior to travel. While traveling, advise patients to bring an adequate supply of ADYNOVATE based on their current regimen of treatment.

To enroll in the confidential, industry-wide Patient Notification System, call 1-888-873-2838.

Baxalta, Advate, Adynovate, and Baxject are trademarks of Baxalta Incorporated.

Patented: see www.baxalta.com/productpatents/.

Baxalta US Inc.
Westlake Village, CA 91362 USA
U.S. License No. 2020

16J050-ADY-US



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