Prescribing Information

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Important Safety Information

Corifact®, FXIII Concentrate (Human), provides routine preventive treatment and management of surgical bleeding in adults and children with congenital Factor XIII deficiency. Corifact must be given by a healthcare professional through an intravenous injection.

Do not use Corifact if you have experienced severe, immediate sensitivity reactions (including shock) to human plasma-derived products. Before being treated with Corifact, tell your healthcare provider about all medical conditions you may have (including pregnancy and breastfeeding), as well as all prescription and non-prescription medications you are using.

Contact your physician, treatment administrator or local emergency department right away if you notice any of the following symptoms after using Corifact: shortness of breath, hives, rash, tightness or pain in the chest, wheezing, fainting or dizziness, and signs of a blood clot (including pain, swelling, warmth, redness, or a lump in the legs or arms).

Other possible side effects include chills or fever, joint pain, headache,and breakthrough bleeding and pain (caused by formation of antibodies against Corifact). These are not all the possible side effects of Corifact. Tell your healthcare professional about any undesirable side effect that bothers you or does not go away.

Corifact is made from human blood plasma, and the risk of transmitting infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Please see full prescribing information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.