Drug Information for INCRELEX™ (mecasermin [rDNA origin] injection) (Tercica, Inc.): DESCRIPTION

INCRELEX™ (mecasermin [rDNA origin] injection) is an aqueous solution for injection containing human insulin-like growth factor-1 (rhIGF-1) produced by recombinant DNA technology. IGF-1 consists of 70 amino acids in a single chain with three intramolecular disulfide bridges and a molecular weight of 7649 daltons. The amino acid sequence of the product is identical to that of endogenous human IGF-1. The rhIGF-1 protein is synthesized in bacteria (E. coli) that have been modified by the addition of the gene for human IGF-1.

Primary Amino Acid Sequence of rhIGF-1

INCRELEX™ is a purified preparation. Biological potency is determined using a bioassay.

INCRELEX™ is a sterile, aqueous, clear and colorless solution intended for subcutaneous injection. Each multi-dose vial of INCRELEX™ contains 10 mg/mL mecasermin, 9 mg/mL benzyl alcohol, 5.84 mg/mL sodium chloride, 2 mg/mL polysorbate 20, and 0.05M acetate at a pH of approximately 5.4.