ADVATE FAQ - Frequently Asked Questions ADVATE FAQ - Frequently Asked Questions

Below you will find helpful information and videos, such as usage, storage, reconstitution, and administration of ADVATE [Octocog alfa (Recombinant Coagulation Factor VIII)], including how to use the BAXJECT II Needleless Transfer Device or BAXJECT III Reconstitution System.1

Contraindications

What are the contraindications for ADVATE?
Hypersensitivity to mouse or hamster proteins, to the active substance or to any of the excipients.

Storage

How should ADVATE be stored?
Store in a refrigerator (2°C–8°C). Do not freeze. During the shelf life, the product may be kept at room temperature (up to 25°C) for a single period not exceeding 6 months. The end of the 6 month’s storage at room temperature should be recorded on the product carton. The product may not be returned to refrigerated storage again.

ADVATE with BAXJECT II device: Keep the product vial in the outer carton in order to protect from light.

ADVATE in BAXJECT III System: Keep the sealed blister in the outer carton in order to protect from light.

Shelf Life

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What is the shelf life of ADVATE?
The shelf life is 2 years. After reconstitution, from a microbiological point of view, the product should be used immediately. However, chemical and physical in-use stability has been demonstrated for 3 hours at 25°C.

Reconstitution with Baxject II

How is ADVATE reconstituted with the BAXJECT II device?
ADVATE is to be administered intravenously after reconstitution of the product.
The reconstituted solution should be inspected visually for any foreign particulate matter and/or discolouration.

After reconstitution the solution should be clear, colourless, and free from foreign particles.
Do not use solutions that are cloudy or have deposits.

  • For administration, the use of a luer-lock syringe is required
  • Use within 3 hours after reconstitution
  • Do not refrigerate the preparation after reconstitution
  • Any unused medicinal product or waste material should be disposed of in accordance with local requirements

Reconstitution with the BAXJECT II device

  • For reconstitution, use only the sterilised water for injections and the reconstitution device provided in the pack
  • Do not use if the BAXJECT II device, its sterile barrier system, or its packaging is damaged or shows any sign of deterioration
  • Aeseptic technique should be used
  1. If the product is still stored in a refrigerator, take both the ADVATE powder and solvent vials from the refrigerator and let them reach room temperature (between 15°C and 25°C).
  2. Wash hands thoroughly using soap and warm water.
  3. Remove caps from powder and solvent vials.
  4. Cleanse stoppers with alcohol swabs. Place the vials on a flat clean surface.
  5. Open the package of the BAXJECT II device (included in ADVATE carton) by peeling away the paper lid without touching the inside (Fig. a). Do not remove the device from the package. Do not use if the BAXJECT II device, its sterile barrier system, or its packaging is damaged or shows any sign of deterioration.
  6. Turn the package over and insert the clear plastic spike through the solvent stopper. Grip the package at its edge and pull the package off BAXJECT II (Fig. b). Do not remove the blue cap from the BAXJECT II device.
  7. For reconstitution, only the water for injections and the reconstitution device provided in the pack should be used. With BAXJECT II attached to the solvent vial, invert the system so that the solvent vial is on top of the device. Insert the white plastic spike through the ADVATE stopper. The vacuum will draw the solvent into the ADVATE vial (Fig. c).
  8. Swirl gently until all material is dissolved. Be sure that ADVATE powder is completely dissolved, otherwise not all reconstituted solution will pass through the device filter. The product dissolves rapidly (usually in less than 1 minute). After reconstitution the solution should be clear, colourless, and free from foreign particles.
instruction figures instruction figures instruction figures

Reconstitution with Baxject III

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How is ADVATE reconstituted with the BAXJECT III System?
ADVATE is to be administered intravenously after reconstitution of the product.
The reconstituted solution should be inspected visually for any foreign particulate matter and/or discolouration.

After reconstitution the solution should be clear, colourless, and free from foreign particles.

Do not use solutions that are cloudy or have deposits.

  • For administration, the use of a luer-lock syringe is required
  • Use within 3 hours after reconstitution
  • Do not refrigerate the preparation after reconstitution
  • Any unused medicinal product or waste material should be disposed of in accordance with local requirements

Reconstitution with the BAXJECT III System

Do not use if the lid is not completely sealed on the blister.

  1. If the product is still stored in a refrigerator, take the sealed blister (contains powder and solvent vials preassembled with the system for reconstitution) from the refrigerator and let it reach room temperature (between 15°C and 25°C).
  2. Wash hands thoroughly using soap and warm water.
  3. Open the ADVATE package by peeling away the lid. Remove the BAXJECT III System from the blister.
  4. Place the ADVATE on a flat surface with the solvent vial on top (Fig. 1). The solvent vial has a blue stripe. Do not remove the blue cap until instructed in a later step.
  5. With one hand holding the ADVATE in the BAXJECT III System, press down firmly on the solvent vial with the other hand until the system is fully collapsed and the solvent flows down into the ADVATE vial (Fig. 2). Do not tilt the system until the transfer is complete.
  6. Verify that the solvent transfer is complete. Swirl gently until all material is dissolved (Fig. 3). Be sure that the ADVATE powder is completely dissolved, otherwise not all reconstituted solution will pass through the device filter. The product dissolves rapidly (usually in less than 1 minute). After reconstitution the solution should be clear, colourless, and free from foreign particles.
baxject step set baxject step press baxject swirl

ADVATE with BAXJECT III System demonstration and troubleshooting videos
The following videos provide detailed instructions on how to properly use the BAXJECT III System.

Demonstration video

Troubleshooting video

Administration

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How is ADVATE administered?
Use aeseptic technique. Parenteral medicinal products should be inspected for particulate matter prior to administration, whenever solution and container permit. Only a clear and colourless solution should be used.

  1. Remove the blue cap from BAXJECT II Needleless Transfer Device or BAXJECT III Reconstitution System.
    DO NOT DRAW AIR INTO THE SYRINGE.
  2. Connect the syringe to BAXJECT II Needleless Transfer Device or BAXJECT III Reconstitution System.
  3. Invert the system (the vial with the reconstituted solution has to be on top). Draw the reconstituted solution into the syringe by pulling the plunger back slowly.
  4. Disconnect the syringe.
  5. Attach a butterfly needle to the syringe. Inject intravenously. The solution should be administered slowly, at a rate as determined by the patient’s comfort level, not to exceed 10 ml per minute. The pulse rate should be determined before and during administration of ADVATE [Octocog alfa (Recombinant Coagulation Factor VIII)]. Should a significant increase occur, reducing the rate of administration or temporarily interrupting the injection usually allows the symptoms to disappear promptly.