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Multiple sclerosis (MS) is a disease in which the nerves of the central nervous system (brain and spinal cord) degenerate. Myelin, which provides a covering or insulation for nerves, improves the conduction of impulses along the nerves and also is important for maintaining the health of the nerves. In multiple sclerosis, inflammation causes the myelin to disappear. Consequently, the electrical impulses that travel along the nerves decelerate, that is, become slower. In addition, the nerves themselves are damaged. As more and more nerves are affected, a person experiences a progressive interference with functions that are controlled by the nervous system such as vision, speech, walking, writing, and memory.
About 350,000 people in the U.S. have multiple sclerosis. Usually, a person is diagnosed with multiple sclerosis between 20 and 50 years of age, but multiple sclerosis has been diagnosed in children and in the elderly. Multiple...
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INFERGEN
(interferon alfacon-1) injection for subcutaneous use
WARNING
FATAL OR LIFE-THREATENING DISORDERS
Alpha interferons, including INFERGEN (interferon alfacon-1) , cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening symptoms of these conditions should be withdrawn from therapy. In many but not all cases, these disorders resolve after stopping interferon alfacon-1 therapy. [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
Use with Ribavirin: Ribavirin may cause birth defects and/or death of the unborn child. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with ribavirin therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen. [see WARNINGS AND PRECAUTIONS; and Ribavirin Full Prescribing Information].
Interferon alfacon-1 is a wholly synthetic type-I interferon. The 166-amino acid sequence of interferon alfacon-1 was derived by scanning the sequences of several natural interferon alpha subtypes and assigning the most frequently observed amino acid in each corresponding position resulting in a consensus sequence. Four additional amino acid changes were made to facilitate the molecular construction, and a corresponding synthetic DNA sequence was constructed using chemical synthesis methodology. Interferon alfacon-1 differs from interferon alfa-2b at 19/166 amino acids (88% homology), and with Interferon alfa-2a at 18/166 amino acids (88% homology). Comparison with interferon-beta shows identity at over 30% of the amino acid positions. Interferon alfacon-1 is produced in Escherichia coli (E. coli) cells that have been genetically altered by insertion of a synthetically constructed sequence that codes for interferon alfacon-1. Prior to final purification, interferon alfacon-1 is allowed to oxidize to its native state, and its final purity is achieved by sequential passage over a series of chromatography columns. This protein has a molecular weight of 19,434 daltons.
INFERGEN (interferon alfacon-1) is a sterile, clear, colorless, preservative-free liquid formulated with 100 mM sodium chloride and 27 mM sodium phosphate at pH 7.0 ± 0.2. The product is available in single-use vials containing 9 mcg and 15 mcg interferon alfacon-1 at a fill volume of 0.3 mL and 0.5 mL, respectively. INFERGEN vials contain 0.03 mg/mL interferon alfacon-1, sodium chloride (5.9 mg/mL), and sodium phosphate (3.8 mg/mL) in Water for Injection, USP. INFERGEN (interferon alfacon-1) is to be administered undiluted by subcutaneous injection.
Last reviewed on RxList: 7/28/2010
This monograph has been modified to include the generic and brand name in many instances.
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