Advate

Name: Advate

What Is Advate?

Antihemophilic factor is a naturally occurring protein in the blood that helps blood to clot. A lack of antihemophilic factor VIII is the cause of hemophilia A.

Recombinant antihemophilic factor works by temporarily raising levels of factor VIII in the blood to aid in clotting.

Recombinant antihemophilic factor is used to treat or prevent bleeding episodes in adults and children with hemophilia A. It is also used to control bleeding related to surgery or dentistry in a person with hemophilia, and to prevent joint damage in people age 16 or older with severe hemophilia A and no prior joint damage.

Recombinant antihemophilic factor is not for use in people with von Willebrand disease.

Recombinant antihemophilic factor may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use this medicine if you have ever had a severe allergic reaction to antihemophilic factor, or if you are allergic to mouse, hamster, or beef proteins.

Before using recombinant antihemophilic factor, your specific blood clotting disorder must be diagnosed as factor VIII deficiency. Recombinant antihemophilic factor will not treat von Willebrand disease.

It is not known whether recombinant antihemophilic factor will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether recombinant antihemophilic factor passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

US Brand Name

  1. Advate
  2. Adynovate
  3. Eloctate
  4. Helixate FS
  5. Hemofil-M
  6. HyateC
  7. Koate DVI
  8. Kogenate FS
  9. Monarc-M
  10. Monoclate-P
  11. Obizur
  12. Xyntha

How to use

This medication is given by injection into a vein as directed by your doctor. The medication may need to be given more slowly over a longer time depending on your dose and how you respond to it.After first receiving this medication in a hemophilia treatment center or hospital, some patients may be able to give this medication to themselves at home. If your doctor directs you to give this medication at home, read the Patient Information Leaflet available from your pharmacist before you start using this medication and each time you get a refill. Learn all preparation and usage instructions in the product package. Learn how to store and discard needles and medical supplies safely. If you have any questions, ask your health care professional.If the medication and the solution used to mix it were refrigerated, bring both to room temperature before combining. After adding the solution to the powder, gently swirl the mixture to completely dissolve the powder. Do not shake. Before using this product, check it visually for particles or discoloration. If either is present, do not use the liquid. Use immediately according to the product instructions.The dosage is based on your medical condition, weight, blood test results, and response to treatment. Follow your doctor's instructions closely.Tell your doctor if your condition does not improve or if it worsens.

Advate and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Advate crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Advate.

 

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Advate?

  • If this medicine is given at home, store unopened containers at room temperature or in the refrigerator. Do not freeze.
  • Store in original container.
  • If stored at room temperature, make a note of the date it was placed at room temperature.
  • Protect from light.
  • If stored at room temperature, throw away any unused vials after 6 months or after the expiration date, whichever comes first.
  • Do not put Advate back in the refrigerator after it has been stored at room temperature.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Indications and Usage for Advate

Control and Prevention of Bleeding Episodes

Advate is an antihemophilic factor (recombinant) indicated for control and prevention of bleeding episodes in adults and children with Hemophilia A.

Perioperative Management

Advate is indicated in the perioperative management in adults and children with Hemophilia A.

Advate is not indicated for the treatment of von Willebrand's disease.

Dosage Forms and Strengths

Advate is available as a lyophilized powder in single use glass vials containing nominally 250, 500, 1000, 1500, 2000 or 3000 International Units (IU).

Each vial of Advate is labeled with the recombinant antihemophilic factor (rAHF) activity expressed in IU per vial. This potency assignment employs a Factor VIII concentrate standard that is referenced to a WHO International Standard for Factor VIII concentrates, and is evaluated by appropriate methodology to ensure accuracy of the results.

Warnings and Precautions

General

The clinical response to Advate may vary. If bleeding is not controlled with the recommended dose, the plasma level of Factor VIII should be determined and a sufficient dose of Advate should be administered to achieve a satisfactory clinical response. If the patient's plasma Factor VIII level fails to increase as expected or if bleeding is not controlled after the expected dose, the presence of an inhibitor (neutralizing antibodies) should be suspected and appropriate testing performed.

Anaphylaxis and Hypersensitivity Reactions

Allergic-type hypersensitivity reactions, including anaphylaxis are possible and have been reported with Advate. Symptoms have manifested as dizziness, paresthesias, rash, flushing, face swelling, urticaria, dyspnea, and pruritis.[see PATIENT COUNSELING INFORMATION (17)]

Advate contains trace amounts of mouse immunoglobulin G (MuIgG; maximum of 0.1 ng.IU Advate) and hamster proteins (maximum of 1.5 ng/IU Advate.. Patients treated with this product may develop hypersensitivity to these non-human mammalian proteins.

Discontinue Advate if hypersensitivity symptoms occur and administer appropriate emergency treatment.

Neutralizing Antibodies

Patients treated with AHF products should be carefully for the development of Factor VIII inhibitors by appropriate clinical observations and laboratory tests. Inhibitors have been reported following administration of Advate predominantly in previously untreated patients (PUPs) and previously minimally treated patients (MTPs). If expected plasma Factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, an assay that measures Factor VIII inhibitor concentration should be performed [see Monitoring Laboratory Tests (5.4)].

Monitoring Laboratory Tests

  • Monitor plasma Factor VIII activity levels by the one-stage clotting assay to confirm the adequate Factor VIII levels have been achieved and maintained, when clinically indicated [see DOSAGE AND ADMINISTRATION (2)].
  • Monitor for development of Factor VIII inhibitors. Perform the Bethesda assay to determine if Factor VIII inhibitor is present. If expected Factor VIII activity plasma levels are not attained, or if bleeding is not controlled with the expected dose of Advate. Use Bethesda Units (BU) to titer inhibitors.
    • If the inhibitor is less than 10 BU per mL, the administration of additional Antihemophilic Factor concentrate may neutralize the inhibitor, and may permit an appropriate hemostatic response.
    • Adequate hemostasis may not be achieved if inhibitor titers are above 10 BU per mL. The inhibitor titer may rise following Advate infusion as a result of an anamnestic response to Factor VIII. The treatment or prevention of bleeding in such patients requires the use of alternative therapeutic approaches and agents.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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