Uses
Prostate Cancer
Palliative treatment of advanced prostate cancer.
First-line therapy alone or in combination with an antiandrogen (e.g., flutamide, bicalutamide, nilutamide) for prostate cancer.
Treatment of locally confined (stage B2 or C) and metastatic (stage D2) prostate cancer; generally used in conjunction with an antiandrogen.
Endometriosis
Palliative treatment of endometriosis (e.g., pain relief, reduction in endometriotic lesions). Experience with leuprolide has been limited to women ≥18 years of age.
Used alone or in conjunction with norethindrone acetate (5 mg daily) for initial management of endometriosis.
Used in conjunction with norethindrone acetate (5 mg daily) if symptoms recur after the initial course of therapy (retreatment). Retreatment with leuprolide alone is not recommended. (See Endometriosis under Dosage and Administration and Musculoskeletal Effects under Cautions.)
Uterine Leiomyomata
Correction of anemia associated with uterine leiomyomata (uterine fibroids) prior to surgery; used in conjunction with iron therapy. Experience with leuprolide has been limited to women ≥18 years of age.
Precocious Puberty
Treatment of central (via activation of the hypothalamic-pituitary-gonadal axis) precocious puberty (true precocious puberty, GnRH-dependent sexual precocity, complete isosexual precocity) in children (designated an orphan drug by FDA for this use).
Treatment with a GnRH analog is indicated for children (girls <8 or boys <9 years of age) who have a clinical diagnosis (confirmed by pubertal response to a GnRH stimulation test) of central idiopathic or neurogenic precocious puberty with onset of secondary sexual characteristics and subsequent rapid advancement of height, height velocity, and/or bone age (e.g., ≥1 year more advanced than their chronologic age).
Some clinicians also state that GnRH analog therapy is indicated in boys <8 years of age with a serum testosterone concentration >100 ng/dL and in girls with onset of menarche and recurrent menses at <9 years of age.
GnRH analogs are considered the therapy of choice for this condition and generally have supplanted medroxyprogesterone in this form of precocity.
GnRH analogs are ineffective as primary therapy in the treatment of GnRH-independent† (peripheral; gonadal steroid secretion is independent of gonadotropin secretion) precocious puberty, including familial male precocious puberty (testotoxicosis), congenital virilizing adrenal hyperplasia (e.g., secondary to steroid 21-hydroxylase, 11β-hydroxylase, or 3β-hydroxysteroid dehydrogenase deficiency), and McCune-Albright syndrome.
Breast Cancer
Has been used in the treatment of breast cancer† in premenopausal and postmenopausal women.
The role of GnRH analogs in the treatment of breast cancer† remains to be elucidated but currently is being studied.
Pending further accumulation of data, many clinicians currently recommend that leuprolide be limited to use in premenopausal women with breast cancer†.