LEUPROLIDE ACETATE

des-Gly10-[D-Leu6]-LH-RH ethylamide; 5-Oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tryosyl-D-leucyl-L- leucyl- L-arginyl-N-ethyl-L-prolinamide monoacetate; Leuprorelin acetate; Lucrin; Lupron; Procrin; Viadur; Eligard; Enantone;

PRODUCT IDENTIFICATION

CAS RN

53714-56-0 (parent), 74381-53-6 (Acetate)

EINECS RN

FORMULA

MOLE WEIGHT

CLASSIFICATION

PHYSICAL AND CHEMICAL PROPERTIES

PHYSICAL STATE

MELTING POINT

BOILING POINT

DENSITY

SOLUBILITY IN WATER

pH

VAPOR DENSITY

REFRACTIVE INDEX

FLASH POINT

INCOMPATIBLE MATERIALS

Strong oxidizing agents.

Carbon monoxide, Carbon dioxide, Nitrogen oxides.

NFPA RATINGS

SAFETY

HAZARD NOTES

EYE

May cause eye irritation.

SKIN

May be harmful if absorbed through skin. May cause skin irritation.

INGESTION

May be harmful if swallowed.

INHALATION

May be harmful if inhaled. May cause respiratory tract irritation.

CHRONIC

TRANSPORT & REGULATORY INFORMATION

UN NO.

HAZARD SYMBOL

RISK PHRASES

SAFETY PHRASES

22-24/25

Leuprolide is FDA approved for the treatment of advanced prostate cancer. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician. Leuprolide is classified as a luteinizing hormone releasing hormone (LHRH) agonist. LHRH is a naturally occurring hormone in the body that is involved in stimulating the production of female and male hormones such as estrogen and testosterone. Leuprolide inhibits the signaling of LHRH so that the production of estrogen or testosterone is reduced. Certain cancers, such as prostate cancer, are stimulated to grow from hormones. The reduction in the production of growth-stimulatory hormones inhibits the growth of cancer cells. (http://www.ufscc.ufl.edu/)

Leuprolide is a luteinizing hormone releasing hormone (LHRH) agonist. It is a synthetic analog of LHRH (also known as gonadotropin releasing hormone [GnRH]).3 LHRH agonists (LHRHa) initially stimulate the release of luteinizing hormone (LH, gonadotropin), resulting in a transient elevation in serum androgen in men and serum estradiol in women. However, chronic administration can cause down-regulation of the LHRH receptors, thus inhibiting the secretion of LH and ultimately the sex hormones (androgen, estradiol). By decreasing the testicular production of androgen in men, LHRHa can inhibit the growth of androgen-dependent prostate cancer. Similarly, LHRHa reduce the ovarian secretion of estradiol and progesterone in women,4 leading to inhibition of estrogen-dependent cancers. In men, LHRHa can reduce serum androgen to castrate level. Similarly, in pre-menopausal women, serum estradiol level is reduced to post-menopausal levels. These decreases occur within two to four weeks after initiation of treatment, and are maintained as long as treatment continues. LHRHa are 50-100 times more potent than LHRH.5 In addition, they have a longer duration of action due to increased receptor affinity and greater biological stability. (http://www.bccancer.bc.ca/)

SALES SPECIFICATION

APPEARANCE

PURITY

98.0% min

RELATED SUBSTANCES

2.0% max (total impurity)

12.0% max

PACKING

PRICE INFORMATION