Infergen
INFERGEN® (InterMune)
(Interferon alfacon-1)
WARNING
Alpha interferons, including lnterferon 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 Patients with persistently severe or worsening symptoms of these conditions should be withdrawn from therapy.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 ADVERSE REACTIONS.
DRUG DESCRIPTION
Interferon alfacon-1 is a recombinant non-naturally occurring 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.1 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-2 at 20/166 amino acids (88% homology), and comparison with interferon-beta shows identity at over 30% of the amino acid positions, a greater similarity than any natural interferon alpha subtype. 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® is the Amgen Inc. trademark for Interferon alfacon-1.
Infergen is a sterile, clear, colorless, preservative-free liquid formulated with 100 mM sodium chloride and 25 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 of Interferon alfacon-1, 5.9 mg/mL sodium chloride, and 3.8 mg/mL sodium phosphate in Water for Injection, USP. Infergen is to be administered undiluted by subcutaneous (SC) injection.
Generic Name: Interferon Alfacon-1
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