Thyrogen Description

thyrotropin alfa




Full Prescribing Info
Each vial of THYROGEN contains 1.1 mg thyrotropin alfa, 36 mg Mannitol, 5.1 mg Sodium Phosphate, and 2.4 mg Sodium Chloride.
THYROGEN (thyrotropin alfa for injection) contains recombinant human thyroid stimulating hormone (TSH). Thyrotropin alfa is synthesized in a genetically modified Chinese hamster ovary cell line.
Thyrotropin alfa is a heterodimeric glycoprotein comprised of two non-covalently linked subunits, an alpha subunit of 92 amino acid residues containing two N-linked glycosylation sites and a beta subunit of 118 residues containing one N-linked glycosylation site. The amino acid sequence of thyrotropin alfa is identical to that of human pituitary TSH.
Both thyrotropin alfa and naturally-occurring human pituitary TSH are synthesized as a mixture of glycosylation variants. Unlike pituitary TSH, which is secreted as a mixture of sialylated and sulfated forms, thyrotropin alfa is sialylated but not sulfated. The biological activity of thyrotropin alfa is determined by a cell-based bioassay. In this assay, cells expressing a functional TSH receptor and a cAMP-responsive element coupled to a heterologous reporter gene, luciferase, enable the measurement of thyrotropin alfa activity by measuring the luciferase response. The specific activity of thyrotropin alfa is determined relative to an internal Genzyme reference standard that was calibrated against the World Health Organization (WHO) human TSH reference standard.
THYROGEN (thyrotropin alfa for injection) is supplied as a sterile, non-pyrogenic, lyophilized product. It is available as a two vial kit containing 1.1 mg of THYROGEN.
THYROGEN is for intramuscular injection to the buttock. The lyophilized powder should be reconstituted immediately prior to use with 1.2 mL of Sterile Water for Injection [see Dosage & Administration]. Each vial of THYROGEN is intended for single use.
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