- In a pivotal clinical study (n=38), 48 surgical procedures, including 31 major orthopedic procedures, were performed22,23
- Orthopedic procedures included total knee replacement, joint fusion, hip replacement, and synovectomy
- 36 of 38 enrolled patients had severe hemophilia A22,23
- 99.6% excellent/good efficacy assessment of ReFacto infusions administered during and after surgery22,23
- Blood loss, transfusion requirements, and reductions in hemoglobin and hematocrit were no greater in these patients than in patients without hemophilia A undergoing similar procedures22,23
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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