What Adynovate is used for and how to use it
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Adynovate - Consumer Medicine Information

Manufacture: Baxalta
Country: United States
Condition: Hemophilia A
Class: Miscellaneous coagulation modifiers
Form: Intravenous (IV), Powder
Ingredients: antihemophilic factor (recombinant) pegylated

[Antihemophilic Factor (Recombinant)]

What is the most important information I need to know about ADVATE?

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 ADVATE so that your treatment will work best for you.

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). The product does not contain plasma or albumin. Hemophilia A is an inherited bleeding disorder that prevents blood from clotting normally.

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.

Who should not use ADVATE?

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.

How should I use ADVATE?

ADVATE is given directly into the bloodstream.

You may infuse ADVATE 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 ADVATE by themselves or with the help of a family member.

Your healthcare provider will tell you how much ADVATE to use based on your weight, the severity of your hemophilia A, and where you are bleeding.

You may have to have blood tests done after getting ADVATE 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 ADVATE.

What should I tell my healthcare provider before I use ADVATE?

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 ADVATE passes into your milk and if it can harm your baby. 
  • Are pregnant or planning to 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 are the possible side effects of ADVATE?

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 rash

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 ADVATE. You can ask your healthcare provider for information that is written for healthcare professionals.

What are the ADVATE dosage strengths?

ADVATE with 2 mL or 5 mL Sterile Water for Injection in a BAXJECT III system comes in six different dosage strengths: 250 International Units (IU), 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU and 4000 IU. The actual strength will be imprinted on the label on the housing and on the box. The six different strengths are color coded, as follows:

 

Dosage strength of approximately
250 International Units
(200–400 IU) (with 2 mL sWFI)

Dosage strength of approximately
500 International Units
(401–800 IU) (with 2 mL sWFI)

Dosage strength of approximately
1000 International Units
(801–1200 IU) (with 2 mL sWFI)

Dosage strength of approximately
1500 International Units
(1201–1800 IU) (with 2 mL sWFI)

Dosage strength of approximately
2000 International Units
(1801–2400 IU) (with 5 mL sWFI)

Dosage strength of approximately
3000 International Units
(2401–3600 IU) (with 5 mL sWFI)

Dosage strength of approximately
4000 International Units
(3601–4800 IU) (with 5 mL sWFI)

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 ADVATE?

Do not freeze ADVATE.

Store ADVATE in a refrigerator (2° to 8°C [36° to 46°F]) or at room temperature (up to 30°C [86°F]) for up to 6 months.

If you choose to store ADVATE at room temperature:

  • Note the date that the product is removed from refrigeration on the box.
  • Do not use after six months from this date or after the expiration date.
  • Do not return the product back to the refrigerator.

Store ADVATE in the original box and protect from extreme exposure to light. Reconstituted product (after mixing dry product with wet diluent) must be used within 3 hours and cannot be stored or refrigerated. Discard any unused ADVATE at the end of your infusion.

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. 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 ADVATE for a condition for which it is not prescribed. Do not share ADVATE with other people, even if they have the same symptoms that you have.

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

See below for step-by-step instructions for reconstituting ADVATE in a BAXJECT III system.

  • Always follow the specific instructions given by your healthcare provider. The steps listed below are general guidelines for using ADVATE. If you are unsure of the procedures, please call your healthcare provider before using. 
  • Call your healthcare provider right away if bleeding is not controlled after using ADVATE. 
  • Your healthcare provider will prescribe the dose that you should take. 
  • Your healthcare provider may need to take blood tests from time to time. 
  • Talk to your healthcare provider before traveling. Plan to bring enough ADVATE for your treatment during this time. 
  • Dispose of all materials, including any leftover reconstituted ADVATE product, in an appropriate container. 
1. Prepare a clean flat surface and gather all the materials you will need for the infusion. Check the expiration date, and let the ADVATE warm up to room temperature. Wash your hands and put on clean exam gloves. If infusing yourself at home, the use of gloves is optional. 





2. Open the ADVATE package by peeling away the lid. Remove the ADVATE from the package and visually inspect the contents of the product and diluent vial. The ADVATE powder should be white to off-white in color and the diluent should not contain particles. Do not use if discoloration or particles are seen.

3. Place on a flat surface with the diluent vial on top. The diluent vial has a blue stripe.

4. With one hand holding the ADVATE housing, press down firmly on the diluent vial with the other hand until the system is fully collapsed and the diluent flows down into the ADVATE vial. Both vials will move into the housing when pressed. If you don’t see the diluent transfer to the product vial, press the vials again to assure they are completely inserted. Do not remove the blue cap until instructed in a later step.

5. Swirl the ADVATE gently and continuously until the ADVATE is completely dissolved. Do not shake. Do not refrigerate after reconstitution. Inspect the ADVATE solution for particulate matter and discoloration prior to administration. The solution should be clear and colorless in appearance. If not, do not use the solution and notify your healthcare provider immediately.



6. Take off the blue cap from the housing and connect the syringe. Be careful to not inject air into the ADVATE.






7. Turn over the ADVATE so that the vial containing the ADVATE solution is on top. Draw the ADVATE solution into the syringe by pulling back the plunger slowly. If the solution does not draw into the syringe, be sure that both vials are pressed firmly together. The contents of more than one vial may be drawn into a single, appropriately sized syringe if you are using more than one vial of ADVATE.

8. Disconnect the syringe from the system. Attach the infusion needle to the syringe using a winged (butterfly) infusion set, if available. Point the needle up and remove any air bubbles by gently tapping the syringe with your finger and slowly and carefully pushing air out of the syringe and needle.

9. Apply a tourniquet and get the injection site ready by wiping the skin well with an alcohol swab (or other suitable solution suggested by your healthcare provider or hemophilia center).

10. Insert the needle into the vein and remove the tourniquet. Slowly infuse the ADVATE. Do not infuse any faster than 10 mL per minute.

11. Take the needle out of the vein and use sterile gauze to put pressure on the infusion site for several minutes.

12. Do not recap the needle. Place the needle, syringe, and ADVATE in a hard-walled sharps container for proper disposal. Do not dispose of these supplies in ordinary household trash.

13. Remove the peel-off label from the housing and place it in your logbook. Clean any spilled blood with a freshly prepared mixture of 1 part bleach and 9 parts water, soap and water, or any household disinfecting solution.

Important: Contact your healthcare provider or local hemophilia treatment center if you experience any problems.

Baxter, Advate, and Baxject are trademarks of Baxter International Inc. registered in the U.S. Patent and Trademark Office.

Patented: see www.baxter.com/productpatents/

Baxter Healthcare Corporation
Westlake Village, CA 91362 USA

U.S. License No. 140

Issued: 05/2015

USBS/34/15-0075