Consumer Information for: CORIFACT 250

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

Corifact 250 / Corifact 1250 (Factor XIII Concentrate, Human) commonly known as Corifact, is an injectable medicine used for routine prophylactic treatment and peri-operative management of surgical bleeding in adults and pediatric patients with congenital Factor XIII (FXIII) deficiency.

What it does

Corifact is a coagulation FXIII concentrate made from human plasma, and has important functions in hemostasis (stopping of bleeding).

When it should not be used

You should not use Corifact if you have experienced hypersensitivity reactions, including anaphylactic or severe systemic reactions to human plasma-derived products or to any ingredient of Corifact.

What the medicinal ingredient is

Corifact is a coagulation FXIII concentrate (See What it does).

What the non-medicinal ingredients are

The other important nonmedicinal ingredients found in Corifact are: Human albumin, glucose monohydrate, and
sodium chloride.
For a full listing of nonmedicinal ingredients see Part 1 of the
Product Monograph.

What dosage form it comes in

Corifact is supplied as a white lyophilized powder in a single use injection vial along with a suitable volume of Sterile Water for Injection (diluent) for reconstitution. It is available in following 2 formats:

250 IU format: The kit for this format contains one product vial containing 250 IU of lyophilized Factor XIII and one diluent vial (4 mL) and one Mix2Vial® filter transfer device.

1250 IU format: The kit for this format contains one product vial containing 1250 IU of lyophilized Factor XIII, one diluent vial (20 mL) and one Mix2Vial® filter transfer device.

Warnings and precautions

Tell your healthcare provider about all of your medical conditions, including:

  • Pregnancy or pregnancy planning: It has not been established if Corifact can harm your unborn baby. The safety and effectiveness in labor and delivery have not been established.
  • Breast feeding: It has not been established if Corifact passes into your milk.
  • Past experience of severe allergic reactions or other reactions with products used to treat your condition or if you have experienced allergic reactions to this drug or its ingredients or components of the container.

Your healthcare provider will consider carefully the benefit of treatment with Corifact compared with the risk of these possible complications.

Because Corifact is made from human plasma, the risk of transmitting infectious agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

Interactions with this medication

To date, no relevant interactions are known.

Proper use of this medication

Corifact is administered into your vein (intravenous injection). Before infusing, Corifact is dissolved using Sterile Water for Injection (diluent) provided in the package.

Usual dose

Your healthcare provider will prescribe the dose that you receive.

Overdose

No cases of overdose have been reported.

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

Missed Dose

Maintain a regular Corifact treatment schedule of dosing every 28 days. If a scheduled Corifact treatment is missed, another treatment should be administered as soon as possible.

Administration: Corifact should be reconstituted according to the instructions below. The reconstituted solution should be administered aseptically by slow intravenous injection at a rate not exceeding 4 mL per minute. Corifact must not be mixed with other medicinal products. It must be administered aseptically through a separate infusion line.

Preparation and Reconstitution

  • Prepare and reconstitute using aseptic techniques.
  • Do not use Corifact beyond the expiration date on the vial label and carton.
  • Perform a visual inspection of the reconstituted solution. Make sure it is colorless to slightly yellowish, slightly opalescent, and free from visible particles

The procedures below are provided as general guidelines for the preparation and reconstitution of Corifact.

Reconstitute Corifact at room temperature as follows:

  1. Bring the Corifact vial and diluent vial to room temperature.
  2. Place the Corifact vial, diluent vial and Mix2Vial® transfer set on a flat surface.
  3. Remove Corifact vial and diluent vial flip caps and wipe the stoppers with an antiseptic. Allow to dry prior to opening the Mix2Vial® transfer set package.
  4. Open the Mix2Vial® transfer set package by peeling away the lid (Fig. 1). To maintain sterility, leave the Mix2Vial® transfer set in its clear outer package.
  5. Place the diluent vial on an even flat surface and hold the vial tightly. Grip the Mix2Vial® transfer set keeping it in the clear package and push the plastic spike of the blue end of the Mix2Vial® transfer set firmly through the center of the diluent vial stopper (Fig. 2).
  6. While holding the diluent vial, carefully remove the outer package from the Mix2Vial® transfer set. Make sure to pull off only the clear package, not the Mix2Vial® transfer set (Fig. 3).
  7. Place the Corifact vial on an even flat surface and hold the vial tight. Invert the diluent vial with the Mix2Vial® transfer set attached to it and push the plastic spike of the clear end of the Mix2Vial® firmly through the center of the stopper of the Corifact vial (Fig. 4). The diluent will transfer into the Corifact vial automatically.
  8. With the diluent and Corifact vial still attached to the Mix2Vial® transfer set, gently swirl the Corifact vial to ensure that the Corifact is fully dissolved (Fig. 5). Do not shake the vial.
  9. With one hand, grip the clear end of the Mix2Vial® transfer set and with the other hand grip the blue end of the Mix2Vial® transfer set, and unscrew counterclockwise the set into two pieces. (Fig. 6).
  10. Draw air into an empty, sterile syringe. With the Corifact vial upright, screw the syringe to the Mix2Vial® transfer set. Inject air into the Corifact vial. While keeping the syringe plunger pressed, invert the Corifact vial and draw the solution into the syringe by pulling the plunger back slowly. (Fig. 7).
  11. Once the solution has been transferred into the syringe, firmly grip the barrel of the syringe (keeping the plunger facing down) and unscrew the syringe counterclockwise from the Mix2Vial® transfer set (Fig. 8). Attach the syringe to an infusion set or another suitable administration set.
  12. If more than one vial is required, the contents of multiple vials may be pooled into a single syringe. Use a separate unused Mix2Vial® transfer set for each product vial.
  13. Corifact is for single use only. It contains no preservatives. The product must be used within 3 hours after reconstitution. Do not refrigerate or freeze the reconstituted solution. Discard partially used vials.
Side effects and what to do about them

Like all medicines, Corifact can cause side effects, although not everybody gets them.

Tell your healthcare provider right away if you have any of the following symptoms after using Corifact:

  • shortness of breath
  • rash
  • pruritus (itching)
  • erythema (redness of the skin)
  • fainting/dizziness
  • chest pain
  • signs of a blood clot including pain, swelling, warmth, redness, or a lump in your legs or arms.

Other possible side effects may include:

  • chills/rise in temperature
  • arthralgia (joint pain)
  • headache
  • increase in liver enzymes
  • breakthrough bleeding and pain resulting from formation of antibodies against Corifact.

This is not a complete list of side effects. For any unexpected effects while taking Corifact, please contact your healthcare provider immediately.

How to store

When stored refrigerated (2 °C to 8 °C), Corifact is stable for the period indicated by the expiration date on the carton and vial label (up to 36 months). Keep Corifact in its original carton until ready to use. Do not freeze. Protect from light.

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 3 ways:

  • Report online at http://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 1908C
      Ottawa, Ontario
      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

This document plus the full Product Monograph, prepared for health professionals can be found at:
http://www.cslbehring.ca

or by contacting the sponsor, CSL Behring Canada, Inc.
at: 1-613-783-1892
This leaflet was prepared by CSL Behring Canada Inc.

Date Last Revised: January 18, 2018

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