Important Safety Information
- BeneFix is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
- Hypersensitivity reactions, including anaphylaxis, have been reported with BeneFix. Closely monitor patients for signs and symptoms of acute anaphylaxis, particularly during the early phases of initial exposure to the product. Immediately discontinue the administration of the product and initiate appropriate treatment if symptoms occur.
- Patients may develop hypersensitivity to hamster (CHO) protein as BeneFix contains trace amounts.
- BeneFix has been associated with the development of thromboembolic complications, including patients receiving continuous infusion through a central venous catheter. The safety and efficacy of BeneFix administration by continuous infusion have not been established.
- Neutralizing antibodies (inhibitors) have been reported following the administration of BeneFix. If expected plasma factor IX activity levels are not attained, or if the patient presents with an allergic reaction, or if bleeding is not controlled following an expected dose of BeneFix, perform an assay that measures factor IX inhibitor concentration.
- The most common adverse reactions (>5% ) from clinical trials were nausea, injection site reaction, injection site pain, headache, dizziness and rash.
Indication
BeneFix, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adult and pediatric patients with hemophilia B (congenital factor IX deficiency or Christmas disease) for the control and prevention of bleeding episodes and peri-operative management.
Limitations of use:
BeneFix is NOT indicated for:
- treatment of other factor deficiencies (eg, factors II, VII, VIII and X),
- treatment of hemophilia A patients with inhibitors to factor VIII,
- reversal of coumarin-induced anticoagulation,
- treatment of bleeding due to low levels of liver-dependent coagulation factors.
Please see Full Prescribing Information for BeneFix.
References
1. Center for Biologics Evaluation and Research, US Food and Drug Administration, US Department of Health and Human Services. CBER Approval Letter, Coagulation Factor IX (Recombinant), Genetics Institute, Inc. http://wayback.archive it.org/7993/20170723024338/https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm057039.htm. Published February 11, 1997. Accessed September 10, 2018.
2. BeneFix [prescribing information]. New York, NY: Pfizer Inc; 2017.
References
1. Center for Biologics Evaluation and Research, US Food and Drug Administration, US Department of Health and Human Services. CBER Approval Letter, Coagulation Factor IX (Recombinant), Genetics Institute, Inc. http://wayback.archive-it.org/7993/20170723024338/https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm057039.htm. Published February 11, 1997. Accessed September 10, 2018.
2. BeneFix [prescribing information]. New York, NY: Pfizer Inc; 2017.
3. Shapiro AD, Di Paola J, Cohen A, et al; for Recombinant Factor IX Study Group. The safety and efficacy of recombinant human blood coagulation factor IX in previously untreated patients with severe or moderately severe hemophilia B. Blood. 2005;105(2):518-525.
4. Roth DA, Kessler CM, Pasi KJ, Rup B, Courter SG, Tubridy KL; for Recombinant Factor IX Study Group. Human recombinant factor IX: safety and efficacy studies in hemophilia B patients previously treated with plasma-derived factor IX concentrates. Blood. 2001;98(13):3600-3606.
5. Ragni MV, Pasi KJ, White GC, Giangrande PL, Courter SG, Tubridy KL; and Recombinant FIX Surgical Study Group. Use of recombinant factor IX in subjects with haemophilia B undergoing surgery. Haemophilia. 2002;8(2):91-97.
6. Data on File. Pfizer Inc, New York, NY.
References
1. Center for Biologics Evaluation and Research, US Food and Drug Administration, US Department of Health and Human Services. CBER Approval Letter, Coagulation Factor IX (Recombinant), Genetics Institute, Inc. http://wayback.archive-it.org/7993/20170723024338/https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm057039.htm. Published February 11, 1997. Accessed September 10, 2018.
2. BeneFix [prescribing information]. New York, NY: Pfizer Inc; 2017.
References
1. Center for Biologics Evaluation and Research, US Food and Drug Administration, US Department of Health and Human Services. CBER Approval Letter, Coagulation Factor IX (Recombinant), Genetics Institute, Inc. http://wayback.archive-it.org/7993/20170723024338/https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm057039.htm. Published February 11, 1997. Accessed September 10, 2018.
2. BeneFix [prescribing information]. New York, NY: Pfizer Inc; 2017.
References
1. Center for Biologics Evaluation and Research, US Food and Drug Administration, US Department of Health and Human Services. CBER Approval Letter, Coagulation Factor IX (Recombinant), Genetics Institute, Inc. http://wayback.archive-it.org/7993/20170723024338/https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm057039.htm. Published February 11, 1997. Accessed September 10, 2018.
2. US National Institutes of Health. Clinical Trials Registry Web site. http://www.clinicaltrials.gov. Accessed September 10, 2018.
3. Summary of Basis for Approval: Coagulation Factor IX (Recombinant) US Food and Drug Administration website. http://wayback.archive-it.org/
7993/20170723024341/https://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM058970.pdf. Accessed July 2, 2018
4. Data on File. Pfizer Inc, New York, NY.
References
1. Center for Biologics Evaluation and Research, US Food and Drug Administration, US Department of Health and Human Services. CBER Approval Letter, Coagulation Factor IX (Recombinant), Genetics Institute, Inc. http://wayback.archive-it.org/7993/20170723024338/https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm057039.htm. Published February 11, 1997. Accessed September 10, 2018.
2. Adamson S, Charlebois T, O'Connell B, Foster W. Viral safety of recombinant factor IX. Semin Hematol. 1998;35(2)(suppl 2):22-27.
3. Harrison S, Adamson S, Bonam D, et al. The manufacturing process for recombinant factor IX. Semin Hematol. 1998;35(2)(suppl 2):4-10.
4. Edwards J, Kirby N. Recombinant coagulation factor IX (BeneFIX). In: Walsh G, Murphy B, eds. Biopharmaceuticals, an Industrial Perspective. Dordrecht, The Netherlands: Kluwer Academic Publishers; 1999:73-108.
5. Data on File. Pfizer Inc, New York, NY.
6. BeneFix [prescribing information]. New York, NY: Pfizer Inc; 2017.
Reference
1. Center for Biologics Evaluation and Research, US Food and Drug Administration, US Department of Health and Human Services. CBER Approval Letter, Coagulation Factor IX (Recombinant), Genetics Institute, Inc. http://wayback.archive-it.org/7993/20170723024338/https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm057039.htm. Published February 11, 1997. Accessed September 10, 2018.
Reference
1. Center for Biologics Evaluation and Research, US Food and Drug Administration, US Department of Health and Human Services. CBER Approval Letter, Coagulation Factor IX (Recombinant), Genetics Institute, Inc. http://wayback.archive-it.org/7993/20170723024338/https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm057039.htm. Published February 11, 1997. Accessed September 10, 2018.
Reference
1. Center for Biologics Evaluation and Research, US Food and Drug Administration, US Department of Health and Human Services. CBER Approval Letter, Coagulation Factor IX (Recombinant), Genetics Institute, Inc. http://wayback.archive-it.org/7993/20170723024338/https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm057039.htm. Published February 11, 1997. Accessed September 10, 2018.
Reference
1. Center for Biologics Evaluation and Research, US Food and Drug Administration, US Department of Health and Human Services. CBER Approval Letter, Coagulation Factor IX (Recombinant), Genetics Institute, Inc. http://wayback.archive-it.org/7993/20170723024338/https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm057039.htm. Published February 11, 1997. Accessed September 10, 2018.
Reference
1. Center for Biologics Evaluation and Research, US Food and Drug Administration, US Department of Health and Human Services. CBER Approval Letter, Coagulation Factor IX (Recombinant), Genetics Institute, Inc. http://wayback.archive-it.org/7993/20170723024338/https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm057039.htm. Published February 11, 1997. Accessed September 10, 2018.