American Thrombosis & Hemostasis Network
The American Thrombosis and Hemostasis Network (ATHN) is a nonprofit organization dedicated to improving the lives of people affected by bleeding and clotting disorders.
World Federation of Hemophilia (WFH)
For over 50 years, the World Federation of Hemophilia (WFH) has worked globally to achieve treatment for all people with hemophilia and other inherited bleeding disorders, no matter where they live in the world.
Foundation for Women & Girls With Bleeding Disorders
The Foundation for Women & Girls With Blood Disorders works to ensure all women and girls with blood disorders are correctly diagnosed and optimally managed at every life stage.
National Hemophilia Foundation
The National Hemophilia Foundation (NHF) is dedicated to finding better treatments and cures for inheritable bleeding disorders and to preventing the complications of these disorders through education, advocacy, and research.
American Society of Hematology
With more than 18,000 members from nearly 100 countries, the ASH is the world's largest professional society serving both clinicians and scientists around the world who are working to conquer blood diseases.
International Society on Thrombosis and Hemostasis
The International Society on Thrombosis and Haemostasis (ISTH) advances the understanding, prevention, diagnosis, and treatment of conditions related to thrombosis and hemostasis.
Hemophilia Federation of America
Hemophilia Federation of America is a national nonprofit organization that assists, educates, and advocates for the bleeding disorders community.
The Anticoagulation Forum is a nonprofit organization of multidisciplinary health care professionals improving the quality of care for patients taking antithrombotic medications.
American Association of Blood Banks
The AABB is an international, not-for-profit Association representing individuals and institutions involved in the fields of transfusion medicine and biotherapies.
ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world.
PubMed® comprises more than 33 million citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full text content from PubMed Central and publisher web sites.
Important Safety Information for Corifact
CORIFACT®, FXIII Concentrate (Human), is indicated for routine prophylactic treatment and perioperative management of surgical bleeding in adult and pediatric patients with congenital Factor XIII deficiency. CORIFACT must be administered intravenously.
CORIFACT is contraindicated in individuals with known anaphylactic or severe systemic reactions to human plasma-derived products.
Hypersensitivity reactions may occur with CORIFACT. If there are signs of anaphylaxis or hypersensitivity reactions (including urticaria, rash, tightness of the chest, wheezing, and hypotension), immediately discontinue administration and institute appropriate treatment.
Inhibitory antibodies to FXIII have been detected in patients receiving CORIFACT. Monitor the patient’s trough FXIII activity level during treatment. If expected plasma FXIII activity levels are not attained or breakthrough bleeding occurs, perform an assay measuring FXIII inhibitory antibody concentrations.
Thromboembolic complications have been reported with CORIFACT; monitor patients with known risk factors for thrombotic events.
CORIFACT is derived from human blood. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.
The most common adverse reactions reported in clinical trials (frequency >1%) following treatment with CORIFACT were joint inflammation, hypersensitivity, rash, pruritus; hematoma, arthralgia, headache, elevated thrombin-anti-thrombin levels, and increased blood lactate dehydrogenase. Serious adverse reactions included hypersensitivity, acute ischemia, and neutralizing antibodies against FXIII.
Please see full prescribing information for CORIFACT.
To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.