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Antihemophilic Factor (Recombinant)
Formulated with Sucrose
Helixate® FS Antihemophilic Factor (recombinant) is a sterile, stable, purified, nonpyrogenic, dried concentrate that has been manufactured using recombinant DNA technology. Helixate FS (antihemophilic factor recombinant) is intended for use in the treatment of classical hemophilia (hemophilia A), and is produced by Baby Hamster Kidney (BHK) cells into which the human factor VIII (FVIII) gene has been introduced.1 The cell culture medium contains Human Plasma Protein Solution (HPPS) and recombinant insulin, but does not contain any proteins derived from animal sources. Helixate FS is a highly purified glycoprotein consisting of multiple peptides including an 80 kD and various extensions of the 90 kD subunit. It has the same biological activity as FVIII derived from human plasma. Compared to its predecessor product HELIXATE® Antihemophilic Factor (Recombinant), Helixate FS (antihemophilic factor recombinant) incorporates a revised purification and formulation process that eliminates the addition of Albumin (Human).
The purification process includes an effective solvent/detergent virus inactivation step in addition to the use of the classical purification methods of ion exchange chromatography, monoclonal antibody immunoaffinity chromatography, along with other chromatographic steps designed to purify recombinant FVIII and remove contaminating substances.
Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.15-27 Several of the individual production and raw material preparation steps in the Helixate FS (antihemophilic factor recombinant) manufacturing process have been shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps included the Fraction II+III separation step for Human Plasma Protein Solution (6.0 log10) and an anion exchange chromatography step (3.6 log10). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.
Helixate FS (antihemophilic factor recombinant) is formulated with sucrose (0.9–1.3%), glycine (21–25 mg/mL), and histidine (18–23 mM) as stabilizers in the final container in place of Albumin (Human) as used in HELIXATE, and is then lyophilized. The final product also contains calcium chloride (2–3 mM), sodium (27–36 mEq/L), chloride (32–40 mEq/L), polysorbate 80 (64-96 µg/mL), and trace amounts of imidazole, tri-n-butyl phosphate, and copper. The product contains no preservatives. The amount of sucrose in each vial is 28 mg.(250, 500, and 1000 IU sizes) and 56mg. Intravenous administration of sucrose contained in Helixate FS (antihemophilic factor recombinant) will not affect blood glucose levels. Each vial of Helixate FS contains the labeled amount of recombinant FVIII in international units (IU). One IU, as defined by the World Health Organization standard for blood coagulation FVIII, human, is approximately equal to the level of FVIII activity found in 1 mL of fresh pooled human plasma. Helixate FS (antihemophilic factor recombinant) must be administered by the intravenous route.
1. Lawn RM, Vehar GA: The molecular genetics of hemophilia. Sci Am 254(3):48–54, 1986.
15. Kimberlin RH, Walker CA: Characteristics of a short incubation model of scrapie in the golden hamster. J Gen Virol 34(2):295-304, 1977.
16. Kimberlin RH, Walker CA: Evidence that the transmission of one source of scrapie agent to hamsters involves separation of agent strains from a mixture. J Gen Virol 39(3):487-96, 1978.
17. Kimberlin RH, Walker CA: Pathogenesis of scrapie (strain 263K) in hamsters infected intracerebrally, intraperitoneally or intraocularly. J Gen Virol 67(2):255-63, 1986.
18. Prusiner SB, et al: Further purification and characterization of scrapie prions. Biochemistry 21(26):6942-50, 1982.
19. Kascsak RJ, et al: Mouse polyclonal and monoclonal antibody to scrapie-associated fibril proteins. J Virol 61(12):3688-93, 1987.
20. Rubenstein R, et al: Scrapie-infected spleens: analysis of infectivity, scrapie-associated fibrils, and protease- resistant proteins. J Infect Dis 164(1):29-35, 1991.
21. Taylor DM, Fernie K: Exposure to autoclaving or sodium hydroxide extends the dose-response curve of the 263K strain of scrapie agent in hamsters. J Gen Virol 77(4):811-13, 1996.
22. Stenland CJ, et al: Partitioning of human and sheep forms of the pathogenic prion protein during the purification of therapeutic proteins from human plasma. Transfusion 42(11):1497-500, 2002.
23. Lee DC, Miller JL, Petteway SR: Pathogen safety of manufacturing processes for biological products: special emphasis on KOGENATE® Bayer. Haemophilia 8(Suppl. 2):6-9, 2002.
24. Lee DC, Stenland CJ, Hartwell RC, et al: Monitoring plasma processing steps with a sensitive Western blot assay for the detection of the prion protein. J Virol Methods 84(1):77-89, 2000.
25. Lee DC, Stenland CJ, Miller JL, et al: A direct relationship between the partitioning of the pathogenic prion protein and transmissible spongiform encephalopathy infectivity during the purification of plasma proteins. Transfusion 41(4):449-55, 2001.
26. Cai K, Miller JL, Stenland CJ, et al: Solvent-dependent precipitation of prion protein. Biochim Biophys Acta 1597(1):28-35, 2002.
27. Trejo SR, Hotta JA, Lebing W, et al: Evaluation of virus and prion reduction in a new intravenous immunoglobulin manufacturing process. Vox Sang 84(3):176-87, 2003.
What are the possible side effects of recombinant antihemophilic factor?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.
Stop using recombinant antihemophilic factor and call your doctor at once if you have a serious side effect such as:
- chest pain;
- easy bruising, increased bleeding episodes; or
- bleeding from a wound or where the medicine was injected.
Less serious side effects may include:
- sore throat, cough, runny nose;
- fever or...
What are the precautions when taking antihemophilic factor (recombinant) (Helixate FS)?
Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or if you have any other allergies. Some brands may also contain animal proteins (such as mouse, hamster) or inactive ingredients (such as natural rubber/latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history.
Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns to normal. Consult your doctor for more...
Last reviewed on RxList: 1/30/2009
This monograph has been modified to include the generic and brand name in many instances.
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