Product Information
Registration Status: ActiveTHYROGEN 0.9mg POWDER FOR SOLUTION FOR INJECTION is approved to be sold in Singapore with effective from 2005-12-27. It is marketed by SANOFI-AVENTIS SINGAPORE PTE LTD, with the registration number of SIN13164P.
This product contains Thyrotropin Alfa 1.1mg in the form of INJECTION, POWDER, FOR SOLUTION. It is approved for INTRAMUSCULAR use.
This product is manufactured by Genzyme Corporation in UNITED STATES, andHospira Inc. in IRELAND.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
Thyrotropin alfa is a recombinant form of thyroid stimulating hormone used in performing certain tests in patients who have or have had thyroid cancer. It is also used along with a radioactive agent to destroy remaining thyroid tissue in certain patients who have had their thyroid gland removed because of thyroid cancer. It 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 112 residues containing one N-linked glycosylation site. The alpha subunit is nearly identical to that of human chorionic gonadotropin (hCG), luteinizing hormone (LH), and follicle-stimulating hormone (FSH). The alpha subunit is thought to be the effector region responsible for stimulation of adenylate cyclase (involved the generation of cAMP). The beta subunit (TSHB) is unique to TSH, and therefore determines its receptor specificity. The amino acid sequence of thyrotropin alfa is identical to that of human pituitary thyroid stimulating hormone.
Indication
For detection of residueal or recurrent thyroid cancer
Mechanism of Action
Thyrotropin Alfa binds to the thyrotropin receptors found on any residual thyroid cells or tissues. This stimulates radioactive iodine uptake for better radiodiagnostic imaging.
Pharmacokinetics
- Absorption
- Time to peak: Median: 10 hours (range: 3-24 hours) After a single intramuscular injection of 0.9 mg of thyrotropin alfa: Cmax= 116+38mU/L, Tmax=22+8.5 hours. AUC=5088+1728 mU·hr/L.
- Distribution
- Metabolism
- Elimination
Toxicity
No difference in efficacy and toxicity between adult and geriatric patients. No studies in lactating women, pregnant women and pediatrics. Cautionary administration is advised.
Active Ingredient/Synonyms
rTSH | Thyroid stimulating hormone | Thyrotrophin-alfa | Thyrotrophin-alpha | Thyrotropin | Thyrotropin-a | Thyrotropin-alpha | Thytrophin | TSH | Thyrotropin Alfa |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.