INFERGEN- interferon alfacon-1 injection
Valeant Pharmaceuticals, Inc.
Alpha interferons, including 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 Patients with persistently severe or worsening symptoms of these conditions should be withdrawn from therapy.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 ADVERSE REACTIONS.
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-2b at 20/166 amino acids (88% homology), and 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 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, 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.
CLINICAL PHARMACOLOGY
General
Interferons are a family of naturally occurring, small protein molecules with molecular weights of 15,000 to 21,000 daltons that are produced and secreted by cells in response to viral infections or to various synthetic and biological inducers. Two major classes of interferons have been identified (i.e., type-I and type-II). Type-I interferons include a family of more than 25 alpha interferons as well as beta interferon and omega interferon. While all alpha interferons have similar biological effects, not all the activities are shared by each alpha interferon and, in many cases, the extent of activity varies substantially for each interferon subtype.