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.
What is the most important information I should 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.
Who should not take 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.
What should I tell my healthcare provider before taking 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).
How should I take 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 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.
What are the possible side effects of Advate?
You can have an allergic reaction to Advate.
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.
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:
- sore throat
- unusual taste
- abdominal pain
- hot flashes
- joint swelling/aching
- swelling of legs
- runny nose/congestion
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.
General information about the safe and effective use of Advate?
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.
Resources at Baxalta available to the patients:
For information on patient assistance programs that are available to you, including the Baxalta CARE Program, please contact the Baxalta Insurance Assistance Helpline at 1-888-229-8379.
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 are the ingredients in Advate?
Active ingredients: antihemophilic factor, human recombinant
Inactive ingredients: mannitol, sodium chloride, histidine, calcium chloride, polysorbate 80, glutathione, trehalose, tromethamine, sterile water for injection