factor XIII

What it is used for

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

Side effects, and when to stop

Call your healthcare provider or the emergency department 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
• breakthrough bleeding and pain resulting from formation of antibodies against CORIFACT.

Because CORIFACT is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob (CJD) agent.

These are not all the possible side effects of CORIFACT.

Tell your healthcare provider about any side effect that bothers you or that does not go away. You can also report side effects to the FDA at 1-800-FDA-1088.

Who should not take it

You should not use CORIFACT if you have experienced hypersensitivity (allergy) reactions, including anaphylactic or severe systemic reactions to human plasma-derived products.

What to say before you start

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

• If you are pregnant or planning to become pregnant. It has not been established if CORIFACT can harm your unborn baby. Safety and effectiveness in labor and delivery have not been established.
• Breast feeding: It has not been established if CORIFACT passes into your milk.

Tell your healthcare provider and pharmacist about all of the medicines you take, including all prescription and non-prescription medicines such as over-the-counter medicines, supplements, or herbal remedies.

How is CORIFACT given?

CORIFACT is administered into your vein (intravenous injection). Before infusing, CORIFACT is dissolved using sterile water provided in the package. Your healthcare provider will prescribe the dose that you receive.

What else should I know about CORIFACT?

Medicines are sometimes prescribed for purposes other than those listed here. Do not use CORIFACT for a condition for which it is not prescribed. Do not share CORIFACT with other people, even if they have the same symptoms that you have.

This leaflet summarizes the most important information about CORIFACT. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about CORIFACT that was written for healthcare professionals.

Talk to your healthcare provider before traveling.

Manufactured by: CSL Behring GmbH 35041 Marburg Germany US License No. 1765

Distributed by: CSL Behring LLC Kankakee, IL 60901 USA

Mix2Vial ® is a registered trademark of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceuticals Services, Inc.

Revised: Month 2020