Product Information
Registration Status: ActiveSIN12507P
LUVERIS FOR INJECTION 75 IU/VIAL (REVISED FORMULA) is approved to be sold in Singapore with effective from 2004-01-30. It is marketed by MERCK PTE LTD, with the registration number of SIN12507P.
This product contains Lutropin Alfa 3.7mcg (82.5IU) (10% overage) in the form of INJECTION, POWDER, FOR SOLUTION. It is approved for SUBCUTANEOUS use.
This product is manufactured by Merck Serono SA in SWITZERLAND.
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.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Lutropin alfa is a recombinant human luteinizing hormone produced in yeast with 2 subunits, alpha = 92 residues, beta = 121 residues. It is a heterodimeric glycoprotein. Each monomeric unit is a glycoprotein molecule. In females, an acute rise of LH ("LH surge") triggers ovulation and the development of the corpus luteum. In males, it stimulates Leydig cell production of testosterone. Lutropin alfa was the first and only recombinant human form of luteinizing hormone (LH) developed for use in the stimulation of follicular development.
Indication
For treatment of infertility in women with hypothalamic or pituitary insufficiency (hypogonadotropic hypogonadism) and profound LH deficiency (LH
Mechanism of Action
Luteinizing hormone binds to a receptor shared with the human chorionic gonadotropin hormone (hCG) on the ovarian theca (and granulosa) cells and testicular Leydig cells. This LH/CG transmembrane receptor is a member of the super-family of G protein-coupled receptors. Adenylate cyclase then activates many other pathways leading to steroid hormone production and other follicle maturation processes.
Pharmacokinetics
- Absorption
- Mean absolute bioavailability is 56%, following sub-Q administration, maximum serum concentrations reached after 4–16 hours. Time to peak, serum: 9 hours
- Distribution
- The steady state volume of distribution is around 10-14 L.
- Metabolism
- Elimination
Clearance
* 2 – 3 L/h [healthy female following subcutaneous administration]
Toxicity
Lutropin alfa is not indicated for people under 16 and over 60, pregnant and lactating women, patients with uncontrolled thyroid and adrenal failure, patients with active, untreated tumours of the hypothalamus and pituitary gland, and in any patient with a condition that makes a normal pregnancy possible such as primary ovarian failure or fibroid tumors of the uterus.
Active Ingredient/Synonyms
ICSH | Insterstiial cell-stimulating hormone | LH | LH-B | LSH- beta | LSH-B | Luteinizing hormone | Luteinizing hormone beta subunit | Lutrophin | Lutropin alpha | Lutropin beta chain precursor | Lutropin 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.