Consumer Information for: ADVATE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

ADVATE - For Reconstitution with 5 mL Diluent

  • routine prophylaxis to prevent or reduce frequency of bleeding episodes in adults and children with hemophilia A
  • ADVATE can temporarily correct the blood clotting process, so it helps prevent and control bleeding in people with Hemophilia A (Factor VIII deficiency).
  • for treatment or prevention of Hemophilia A-related bleeding.

ADVATE - For Reconstitution with 2 mL Diluent

  • routine prophylaxis to prevent or reduce frequency of bleeding episodes in adults and children with hemophilia A
  • ADVATE can temporarily correct the blood clotting process, so it helps prevent and control bleeding in people with Hemophilia A (Factor VIII deficiency).
  • for treatment or prevention of Hemophilia A-related bleeding.
What it does

ADVATE - For Reconstitution with 5 mL Diluent

ADVATE temporarily raises the level of Factor VIII in the blood to a more normal level, allowing your body’s blood clotting process to function properly.

ADVATE - For Reconstitution with 2 mL Diluent

ADVATE temporarily raises the level of Factor VIII in the blood to a more normal level, allowing your body’s blood clotting process to function properly.

When it should not be used

ADVATE - For Reconstitution with 5 mL Diluent

You should not use ADVATE unless your doctor confirms that you have Hemophilia A. Patients with known allergic-type reactions to mouse or hamster proteins should talk to their doctor before using this product. ADVATE is not indicated for the treatment of von Willebrands Disease.

ADVATE - For Reconstitution with 2 mL Diluent

You should not use ADVATE unless your doctor confirms that you have Hemophilia A. Patients with known allergic-type reactions to mouse or hamster proteins should talk to their doctor before using this product.
ADVATE is not indicated for the treatment of von Willebrands Disease.

What the medicinal ingredient is

ADVATE - For Reconstitution with 5 mL Diluent

ADVATE Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method (rAHF PFM)

ADVATE - For Reconstitution with 2 mL Diluent

ADVATE Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method (rAHF PFM)

What the non-medicinal ingredients are

ADVATE - For Reconstitution with 5 mL Diluent

Calcium, glutathione, histidine, Mannitol, polysorbate-80, trehalose, sodium, Tris (hydroxymethyl) aminomethane
For a full listing of nonmedicinal ingredients see Part 1 of the product monograph.

ADVATE - For Reconstitution with 2 mL Diluent

Calcium, glutathione, histidine, Mannitol, polysorbate-80, trehalose, sodium, Tris (hydroxymethyl) aminomethane For a full listing of nonmedicinal ingredients see Part 1 of the product monograph.

What dosage form it comes in

ADVATE - For Reconstitution with 5 mL Diluent

ADVATE - For Reconstitution with 2 mL Diluent

For Reconstitution with 5 mL Diluent

ADVATE is available in single-dose vials that contain nominally 1000, 1500, 2000 and 3000 International Units (IU) per vial reconstituted in 5 mL of water for injection.

For Reconstitution with 2 mL Diluent

ADVATE is available in single-dose vials that contain nominally 250, 500, 1000 and 1500 International Units (IU) per vial reconstituted in 2 mL of water for injection.

Warnings and precautions

ADVATE - For Reconstitution with 5 mL Diluent

BEFORE you use ADVATE talk to your doctor or pharmacist if you have known allergies:

  • to mouse or hamster proteins.
  • to this drug or to any ingredient in the formulation or component of the product.

Your body may form inhibitors to Factor VIII. An inhibitor is an antibody (part of your body’s normal immune defenses) that forms in response to infusions of Factor VIII that prevents the Factor VIII from working properly. These inhibitors can lead to a reduced response, or to no response to Factor VIII therapy. This is not an uncommon complication in the treatment of people with Hemophilia A. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII. Contact your doctor if you are not able to prevent or control bleeding episodes with your regular doses of prescribed Factor VIII therapy. (see SIDE EFFECTS AND WHAT TO DO ABOUT THEM)

ADVATE - For Reconstitution with 2 mL Diluent

BEFORE you use ADVATE talk to your doctor or pharmacist if you have known allergies:

  • to mouse or hamster proteins.
  • to this drug or to any ingredient in the formulation or component of the product.

Your body may form inhibitors to Factor VIII. An inhibitor is an antibody (part of your body’s normal immune defenses) that forms in response to infusions of Factor VIII that prevents the Factor VIII from working properly. These inhibitors can lead to a reduced response, or to no response to Factor VIII therapy. This is not an uncommon complication in the treatment of people with Hemophilia A. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII. Contact your doctor if you are not able to prevent or control bleeding episodes with your regular doses of prescribed Factor VIII therapy. (see SIDE EFFECTS AND WHAT TO DO ABOUT THEM)

Interactions with this medication

ADVATE - For Reconstitution with 5 mL Diluent

No interaction of ADVATE with other medicinal products is known or has been established.

ADVATE - For Reconstitution with 2 mL Diluent

No interaction of ADVATE with other medicinal products is known or has been established.

Proper use of this medication

ADVATE - For Reconstitution with 5 mL Diluent

Usual Dose

Individual doses are usually between 20 – 50 IU Factor VIII/kg body weight, as determined by your physician. Physician supervision of the treatment regimen is required.

Overdose

No safety concerns were identified in association with clinical study patients who received doses up to four times greater than the maximum recommended usual dose.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

  • Double doses are generally not required to compensate for forgotten individual doses.
  • Patients should be advised to proceed immediately with a regular administration of ADVATE and to continue treatment at regular intervals as required.

ADVATE - For Reconstitution with 2 mL Diluent

Usual Dose

Individual doses are usually between 20 – 50 IU Factor VIII/kg body weight, as determined by your physician. Physician supervision of the treatment regimen is required.

Overdose

No safety concerns were identified in association with clinical study patients who received doses up to four times greater than the maximum recommended usual dose.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

  • Double doses are generally not required to compensate for forgotten individual doses.
  • Patients should be advised to proceed immediately with a regular administration of ADVATE and to continue treatment at regular intervals as required.
Side effects and what to do about them

ADVATE - For Reconstitution with 5 mL Diluent

  • Should a significant increase in pulse rate during administration of ADVATE occur, reducing the rate of administration or temporarily halting the injection usually allows the symptoms to disappear promptly.
  • There is a possibility that you could have an allergic reaction to ADVATE. Allergic reactions to ADVATE may manifest with any of the following: rash, hives, itching, tightness of the chest, difficulty breathing, throat tightness, and/or low blood pressure (e.g. weak pulse, feeling lightheaded or dizzy when you stand, and possibly shortness of breath). If you experience any of these symptoms, stop the infusion and immediately phone your doctor or go to the Emergency Department.
  • As with all Factor VIII products, the clinical response to ADVATE may vary. If your bleeding is not controlled after infusing ADVATE, contact your doctor immediately. Your Factor VIII level may need to be measured by your physician who may recommend another dose of ADVATE in order to achieve a satisfactory clinical response. If your plasma Factor VIII level fails to increase as expected or if bleeding is not controlled after adequate dosing, your physician may test for the presence of an inhibitor (neutralizing antibodies).

This is not a complete list of side effects. For any unexpected effects while taking ADVATE, contact your doctor or pharmacist.

ADVATE - For Reconstitution with 2 mL Diluent

  • Should a significant increase in pulse rate during administration of ADVATE occur, reducing the rate of administration or temporarily halting the injection usually allows the symptoms to disappear promptly.
  • There is a possibility that you could have an allergic reaction to ADVATE. Allergic reactions to ADVATE may manifest with any of the following: rash, hives, itching, tightness of the chest, difficulty breathing, throat tightness, and/or low blood pressure (e.g. weak pulse, feeling lightheaded or dizzy when you stand, and possibly shortness of breath). If you experience any of these symptoms, stop the infusion and immediately phone your doctor or go to the Emergency Department.
  • As with all Factor VIII products, the clinical response to ADVATE may vary. If your bleeding is not controlled after infusing ADVATE, contact your doctor immediately. Your Factor VIII level may need to be measured by your physician who may recommend another dose of ADVATE in order to achieve a satisfactory clinical response. If your plasma Factor VIII level fails to increase as expected or if bleeding is not controlled after adequate dosing, your physician may test for the presence of an inhibitor (neutralizing antibodies).

This is not a complete list of side effects. For any unexpected effects while taking ADVATE, contact your doctor or pharmacist.

How to store

ADVATE - For Reconstitution with 5 mL Diluent

  • ADVATE should be refrigerated (2°C- 8°C [36°F - 46°F]). Avoid freezing to prevent damage to the diluent vial.
  • ADVATE may be stored at room temperature (up to 30°C [86°F]) for a period of up to six months not to exceed the expiration date.
  • Do not place back in the refrigerator once removed from refrigerated storage.
  • Do not refrigerate preparation after reconstitution.
  • Do not use beyond the expiration date printed on the vial or six months after date noted on the carton, whichever is the earliest.

ADVATE - For Reconstitution with 2 mL Diluent

  • ADVATE should be refrigerated (2°C- 8°C [36°F - 46°F]). Avoid freezing to prevent damage to the diluent vial.
  • ADVATE may be stored at room temperature (up to 30°C [86°F]) for a period of up to six months not to exceed the expiration date.
  • Do not place back in the refrigerator once removed from refrigerated storage.
  • Do not refrigerate preparation after reconstitution.
  • Do not use beyond the expiration date printed on the vial or six months after date noted on the carton, whichever is the earliest.
Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

INSTRUCTIONS FOR USING ADVATE

Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (For intravenous use only)

IMPORTANT: Contact your doctor or local Hemophilia Treatment Centre if you experience any problems with this procedure. These instructions are intended only as a visual aid for those patients who have been instructed by their doctor or hemophilia center on the proper way to self-infuse the product (diagrams are representational and may not be drawn exactly to scale). Do not attempt to self-infuse unless you have been taught how by your doctor or hemophilia center.

In a quiet place, prepare a clean surface and gather all the materials you will need for the infusion. Check the expiration date on the ADVATE concentrate vial or package, and let the vial with the ADVATE concentrate and the Sterile Water for Injection USP (diluent) warm up to room temperature. Wash your hands and put on clean exam gloves. If self-infusing at home, the use of gloves is optional.

1. After washing your hands and putting on gloves, remove caps from the factor concentrate and diluent vials to expose the centers of the rubber stoppers.

2. Disinfect the stoppers with a sterile alcohol swab (or other suitable solution suggested by your doctor or hemophilia center) by rubbing the stoppers firmly for several seconds, and allow to dry prior to use. Place the vials on a flat surface.

3. Open the BAXJECT II device package by peeling away the lid, without touching the inside of the package. The BAXJECT II device remains in the package at this time. Do not remove the device from the package.

4. Turn the package with the device upside down, and place it over the top of the diluent vial. Fully insert the clear plastic spike of the BAXJECT II device into the center of the diluent vial’s stopper by pushing straight down. Grip the package at its edge and pull it off the device. After removing the packaging, be careful not to touch the white plastic exposed spike. Do not remove the blue luer cap from BAXJECT II device. Please note that the connection of the two vials should be done expeditiously to close the open fluid pathway created by the first insertion of the spike to the diluent vial.

5. Quickly turn over the diluent vial with the BAXJECT II device, place on top of the vial containing the factor concentrate, and fully insert the white plastic spike into the factor concentrate vial’s stopper by pushing straight down. The vacuum will draw the diluent into the factor concentrate vial.

6. Swirl the factor concentrate gently and continuously with the BAXJECT II device attached until it is completely dissolved. Do not shake. Check to make sure the factor concentrate is completely dissolved. The solution should be clear and colourless in appearance. If not, do not use the solution and notify Baxalta immediately.

7. Remove the blue luer cap from the BAXJECT II device. Connect the syringe to the BAXJECT II device. DO NOT INJECT AIR.

8. Turn the system over so that the factor concentrate solution vial is on top. Withdraw the factor concentrate solution into the syringe by pulling back the plunger slowly. Disconnect the syringe, leaving the BAXJECT II device connected. Attach the infusion needle to the syringe using a winged 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. Dispose of the used BAXJECT II system in your hard-walled Sharps container, without taking it apart.

9. If receiving more than one vial of ADVATE, the contents of multiple vials may be drawn into the same syringe. Please note that the BAXJECT II device is intended for use with a single vial of ADVATE and Sterile Water for Injection only, therefore reconstituting and withdrawing a second vial into the syringe requires a second BAXJECT II device.

10. Apply a tourniquet, and prepare the injection site by wiping the skin well with a sterile alcohol swab (or other suitable solution suggested by your doctor or hemophilia center).

11. Insert the needle into the vein, and remove the tourniquet. Infuse the factor concentrate. Do not infuse any faster than 10mL per minute. Remove the needle from the vein and apply pressure with sterile gauze to the infusion site for several minutes. Do not recap the needle after the infusion, and do not dispose in ordinary household trash. Place it with the used syringe in a hard-walled Sharps container for proper disposal.

12. After the infusion, remove the peel-off label from the factor concentrate vial and place it in your factor log book. Clean up any spilled blood with a freshly prepared mixture of 1 part bleach and 9 parts water, soap and water, or any household disinfecting solution.

Complete information on reconstituting with Baxject II can be found at: www.baxject2.com

BAXTER, ADVATE, AND BAXJECT are trademarks of Baxalta Incorporated.

Manufactured by:
Baxalta US Inc.
Westlake Village, CA 91362 USA

Imported by:
Baxalta Canada Corporation
7125 Mississauga Rd
Mississauga, ON L5N 0C2

This document plus the full product monograph, prepared for health professionals can be found at: http://www.ADVATE.ca or by contacting, Baxalta Canada Corporation at: 1-800-387-8399

Visit
The Health Canada
Biologics and Genetics Therapies Directorate at : http://www.hc-sc.gc.ca/dhp-mps/brgtherap/index_e.html This leaflet was prepared by Baxalta Canada Corporation Last revised: TBD

Date modified: