Corifact

Corifact® Factor XIII Concentrate
(Human)

This leaflet summarizes important information about Corifact. Please read it carefully before using Corifact and each time you get a refill. There may be new information provided. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about Corifact. If you have any questions after reading this, ask your healthcare provider.

What is Corifact?

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).

Who should not use Corifact?

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

What should I tell my healthcare provider before Corifact is given?

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.
• Labor and Delivery: 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 could be the possible side effects of Corifact?

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, 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.

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.

• Advate
• Adynovate
• Bebulin VH
• BeneFIX

• Coagadex
• Eloctate
• Feiba Vh
• Profilnine

© Corifact Patient Information is supplied by Cerner Multum, Inc. and Corifact Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

You should not use this medicine if you are allergic to any medicine made with human plasma.

Other drugs may interact with factor XIII, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Congenital Factor XIII Deficiency

Routine prophylaxis and perioperative management of bleeding in patients with congenital factor XIII deficiency;1 7 8 13 14 15 29 31 33 34 36 designated an orphan drug by FDA for treatment of congenital factor XIII deficiency.12

Initial FDA-labeled use based on trough factor XIII levels (5–20%) as a surrogate measure of efficacy; clinical benefit (i.e., prevention of bleeding episodes) established in a postmarketing study.1 29 33

Prophylactic therapy with factor XIII concentrates is recommended in all patients with severe (<1% factor XIII activity) deficiency; considered current standard of care.7 8 25 34 38

Currently available factor XIII concentrates in the US include a plasma-derived (Corifact) and a recombinant (Tretten) preparation.1 10 30 31 Some experts recommend preferential use of recombinant preparations because of their potentially superior safety profile with respect to pathogen transmission.30 (See Risk of Transmissible Agents in Plasma-derived Preparations under Cautions.) When selecting an appropriate factor XIII preparation, consider characteristics of each clotting factor concentrate in addition to individual patient variables.32

Acquired Factor XIII Deficiency

Has been used to treat acquired factor XIII deficiency† associated with various diseases or other conditions.2 3 5 9 17 18 19 21 22 25

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Joint pain.
• Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Corifact is available as a single-use vial containing 1000-1600 units of FXIII as a lyophilized concentrate. A 20 mL vial of Sterile Water for Injection, USP, is provided for reconstitution.

The actual units of potency of FXIII are stated on each Corifact vial label and carton.

1. Hsieh L, Nugent D. Factor XIII deficiency. Haemophilia 2008; 14:1190-1200.
2. Lauer P, Metzner HJ, Zettlmeißl G, Li M, et al. Targeted Inactivation of the Mouse Locus Encoding Coagulation Factor XIII-A: Hemostatic Abnormalities in Mutant Mice and Characterization of the Coagulation Deficit. Thromb Haemost. 2002;88:967-74.
3. Dardik R, Loscalzo J, Inbal A. Factor XIII (FXIII) and Angiogenesis. J Thromb Haemost. 2006;4:19-25.

Call your doctor for instructions if you miss a dose of Corifact.

Factor XIII has been assign to pregnancy category C by the FDA. Animal studies have not revealed evidence of teratogenicity. There are no controlled data in human pregnancy. Factor XIII is only recommended for use during pregnancy when benefit outweighs risk.