Levemir (Insulin Detemir Subcutaneous) - Description

DESCRIPTION

LEVEMIR^® (insulin detemir [rDNA origin] injection) is a sterile solution of insulin detemir for use as an injection. Insulin detemir is a long-acting basal insulin analog, with up to 24 hours duration of action, produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical modification.

Insulin detemir differs from human insulin in that the amino acid threonine in position B30 has been omitted, and a C14 fatty acid chain has been attached to the amino acid B29. Insulin detemir has a molecular formula of C₂₆₇H₄₀₂O₇₆N₆₄S₆ and a molecular weight of 5916.9. It has the following structure:

LEVEMIR is a clear, colorless, aqueous, neutral sterile solution. Each milliliter of LEVEMIR contains 100 U (14.2 mg/mL) insulin detemir, 65.4 mcg zinc, 2.06 mg m-cresol, 30.0 mg mannitol, 1.80 mg phenol, 0.89 mg disodium phosphate dihydrate, 1.17 mg sodium chloride, and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. LEVEMIR has a pH of approximately 7.4.