Additional Resources
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.
Anticoagulation Forum
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
ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world.
Pubmed.gov
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 IDELVION
IDELVION®, Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rFIX-FP), is indicated in children and adults with hemophilia B (congenital Factor IX deficiency) for:
- On-demand treatment and control of bleeding episodes
- Perioperative management of bleeding
- Routine prophylaxis to reduce the frequency of bleeding episodes
IDELVION is not indicated for induction of immune tolerance in patients with hemophilia B.
IDELVION is contraindicated in patients who have had life-threatening hypersensitivity to the product or its components, including hamster proteins.
IDELVION is for intravenous use only. IDELVION can be self-administered or administered by a caregiver with training and approval from a healthcare provider or hemophilia treatment center. Higher dose per kilogram body weight or more frequent dosing may be needed for pediatric patients.
Hypersensitivity reactions, including anaphylaxis, are possible. Advise patients who self-administer to immediately report symptoms of hypersensitivity, including angioedema, chest tightness, hypotension, generalized urticaria, wheezing, and dyspnea. If symptoms occur, discontinue IDELVION and administer appropriate treatment.
The formation of neutralizing antibodies (inhibitors) to Factor IX has been reported with IDELVION. If expected Factor IX activity plasma levels are not attained or bleeding is not controlled with appropriate dose, perform an assay to measure Factor IX inhibitor concentration. Factor IX activity assay results may vary with the type of activated partial thromboplastin time reagent used.
Thromboembolism (eg, pulmonary embolism, venous thrombosis, and arterial thrombosis) can occur when using Factor IX-containing products. In addition, nephrotic syndrome has been reported following immune tolerance induction in hemophilia B patients with Factor IX inhibitors and allergic reactions to Factor IX.
The most common adverse reactions (incidence ≥1%) reported in clinical trials were headache and dizziness.
Please see full prescribing information for IDELVION.
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.
