B-Domain-Deleted (BDD) Factor VIII Has Full Biologic Activity Compared With Other Factor VIII Preparations32
- The deleted B-domain is not required for hemostasis32
- The BDD molecule retains all of the critical properties of the active full-length form of factor VIII necessary for successful hemostasis treatment32
- Functional characteristics of ReFacto are comparable to those of plasma-derived and BDD plasma-derived factor VIII (pdFVIII)32
- A clinical study showed that the pharmacokinetics of ReFacto and a full-length recombinant factor VIII product are comparable21
Indication ReFacto is indicated for the control and prevention of hemorrhagic episodes and for surgical prophylaxis and for short-term routine prophylaxis to reduce the frequency of spontaneous bleeding episodes in patients with hemophilia A. The effect of regular routine prophylaxis on long-term morbidity and mortality is unknown.
Important Safety Information
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As with the intravenous administration of any protein product, adverse reactions may include headache, fever, chills, flushing, nausea, vomiting, tiredness, or symptoms of allergic reactions. |
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The remote possibility exists for hypersensitivity to non-human mammalian proteins. Known hypersensitivity to mouse or hamster proteins may be a contraindication to the use of ReFacto. |
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Allergic reactions such as hives, itching, difficulty breathing, rapid heart rate, light-headedness and anaphylaxis have been reported for all factor VIII products. Patients should discontinue use of the product and contact their health care provider immediately and/or seek emergency care if any of these symptoms occur. |
Please see ReFacto Prescribing Information The health information contained herein is provided for educational purposes only and is not meant to replace personal discussions between health care providers and patients. All decisions about patient care must be made with a health care provider who can assess the special needs of each individual patient.
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