Eligard (leuprolide acetate)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
General Information
Eligard 7.5mg (formerly Leuprogel One-Month Depot) has been
approved by the FDA for the treatment of advanced prostate cancer.
Eligard (for subcutaneous injection) is designed to deliver 7.5 mg
of leuprolide acetate at a controlled rate over a one-month
therapeutic period.
Atrix is developing various leuprolide acetate formulations
based on the company's Atrigel drug delivery system. The
product is injected into the body in a liquid form, where it
solidifies and continuously releases a predetermined dose of
leuprolide acetate. Sustained levels of leuprolide, a luteinizing
hormone-releasing hormone (LHRH) agonist, decrease testosterone to
suppress tumor growth in patients with hormone-responsive prostate
cancer.
Side Effects
Adverse events reported from clinical testing of Eligard include
(but are not limited to) the following:
- Malaise
- Fatigue
- Dizziness
- Hot flashes/sweats
- Gastroenteritis
- Colitis
Mechanism of Action
Leuprolide acetate, an LH-RH agonist, acts as a potent inhibitor
of gonadotropin secretion when given continuously in therapeutic
doses. Animal and human studies indicate that after an initial
stimulation, chronic administration of leuprolide acetate results
in suppression of ovarian and testicular steroidogenesis. This
effect is reversible upon discontinuation of drug therapy.
In humans, administration of leuprolide acetate results in an
initial increase in circulating levels of luteinizing hormone (LH)
and follicle stimulating hormone (FSH), leading to a transient
increase in levels of the gonadal steroids (testosterone and
dihydrotestosterone in males, and estrone and estradiol in
premenopausal females). However, continuous administration of
leuprolide acetate results in decreased levels of LH and FSH. In
males, testosterone is reduced to below castrate threshold. These
decreases occur within two to four weeks after initiation of
treatment. Long-term studies have shown that continuation of
therapy with leuprolide acetate maintains testosterone below the
castrate level for up to seven years. (from Eligard FDA Label)
Additional Information
Sanofi-Synthelabo is Atrix's marketing partner for the
Eligard product line. Atrix is developing two additional Eligard
products that release leuprolide acetate over a period of three and
four months.
For more information on Eligard, please visit
Atrix
Laboratories.
