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 AFSTYLA
AFSTYLA®, Antihemophilic Factor (Recombinant), Single Chain, is contraindicated in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis to AFSTYLA or its excipients, or hamster proteins.
AFSTYLA is for intravenous use only. AFSTYLA can be self-administered or administered by a caregiver with training and approval from a healthcare provider or hemophilia treatment center. Higher and/or more frequent dosing may be needed for patients under 12 years of age.
Hypersensitivity reactions, including anaphylaxis, are possible. Advise patients to immediately report symptoms of a hypersensitivity reaction. Should symptoms occur, immediately discontinue AFSTYLA and administer appropriate treatment.
Formation of neutralizing antibodies (inhibitors) has been reported following administration of AFSTYLA; previously untreated patients (PUPs) are at greater risk. If expected plasma Factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures Factor VIII inhibitor concentration.
Monitor plasma FVIII activity using a chromogenic assay or one-stage clotting assay. If one-stage clotting assay is used, multiply result by a conversion factor of 2 to determine FVIII activity level.
The most common adverse reactions reported in clinical trials (>0.5% of subjects) were Factor VIII inhibition in previously untreated patients (PUPs), dizziness, and hypersensitivity.
Indications for AFSTYLA
AFSTYLA®, Antihemophilic Factor (Recombinant), Single Chain, is indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for:
- On-demand treatment and control of bleeding episodes
- Routine prophylaxis to reduce frequency of bleeding episodes
- Perioperative management of bleeding
AFSTYLA is not indicated for the treatment of von Willebrand disease.
Please see full prescribing information for AFSTYLA.
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.