Uterine Leiomyomata (Fibroids)
LUPRON DEPOT® (leuprolide acetate for depot suspension) 3.75 mg for 1-month and 11.25 mg for 3-month administration concomitantly with iron therapy are indicated for the preoperative hematologic improvement of patients with anemia caused by uterine leiomyomata. The clinician may wish to consider a one-month trial period on iron alone inasmuch as some of the patients will respond to iron alone. LUPRON DEPOT may be added if the response to iron alone is considered inadequate. Recommended duration of therapy with LUPRON DEPOT 3.75 mg is up to three months.
The 3-month 11.25 mg dosage form is indicated only for women for whom three months of hormonal suppression is deemed necessary. Experience with LUPRON DEPOT in females has been limited to women 18 years of age and older.
LUPRON DEPOT® (leuprolide acetate for depot suspension) 3.75 mg for 1-month and 11.25 mg for 3-month administration are indicated for the management of endometriosis, including pain relief and reduction of endometriotic lesions. LUPRON DEPOT with daily norethindrone acetate 5 mg is also indicated for initial management of endometriosis and for management of recurrence of symptoms. Duration of initial treatment or retreatment should be limited to 6 months.
Advanced Prostate Cancer
LUPRON DEPOT® (leuprolide acetate for depot suspension) 7.5 mg for 1-month, 22.5 mg for 3-month, 30 mg for 4-month, and 45 mg for 6-month administration are indicated for the palliative treatment of advanced prostatic cancer.
LUPRON DEPOT is a gonadotropin-releasing hormone (GnRH) agonist administered as a single intramuscular injection under the supervision of a physician.
Central Precocious Puberty
LUPRON DEPOT-PED® 7.5 mg, 11.25 mg, and 15 mg for 1-month and 11.25 mg and 30 mg for 3-month administration are indicated in the treatment of children with central precocious puberty (CPP).
CPP is defined as early onset of secondary sexual characteristics (generally earlier than 8 years of age in girls and 9 years of age in boys) associated with pubertal pituitary gonadotropin activation. It may show a significantly advanced bone age that can result in diminished adult height.
Prior to initiation of treatment, confirm diagnosis of CPP by testing luteinizing hormone (LH) and sex steroid levels, and assess bone age versus chronological age. Baseline evaluations should be done to rule out intracranial tumor, steroid secreting tumors, a chorionic gonadotropin secreting tumor, and congenital adrenal hyperplasia.
Important Safety Information1-3
General Information: LUPRON DEPOT, including LUPRON DEPOT-PED, is contraindicated in patients with hypersensitivity to GnRH agonists or any of the excipients in LUPRON DEPOT, and in females who are or may become pregnant, breastfeeding, or women with undiagnosed abnormal vaginal bleeding. LUPRON DEPOT may cause fetal harm when administered to pregnant women. If used during pregnancy, the patient should be apprised of the potential hazard to the fetus, and that spontaneous abortion may occur. Before starting treatment with LUPRON DEPOT, pregnancy must be excluded.
Transient worsening of symptoms or the occurrence of additional signs and symptoms may develop during the first few weeks of LUPRON DEPOT treatment in all indications. Due to the suppression of the pituitary-gonadal system by LUPRON DEPOT, diagnostic tests of pituitary gonadotropic and gonadal functions conducted during treatment, and for up to 6 months after discontinuation, may be affected.
It usually inhibits ovulation and stops menstruation. Females should use non-hormonal methods of contraception. Postmarketing reports of convulsions have been observed in patients on GnRH agonists, including leuprolide acetate, including patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications associated with convulsions, such as bupropion and SSRIs.
Convulsions have also been reported in the absence of any of the conditions mentioned above. LUPRON DEPOT must be administered under the supervision of a physician.
Endometriosis/Uterine Leiomyomata (Fibroids): Patients who have a history of depression should be carefully observed and counseled on the possibility of the development or worsening of depression and the occurrence of memory disorders. Mean changes in cholesterol, LDL, HDL, and the LDL/HDL ratios were observed. Induced hypoestrogenic state resulted in bone loss (average of 3.2% in endometriosis patients and 2.7% in fibroid patients compared with the pretreatment value) over a course of treatment, which may not be reversible.
In patients with major risk factors for decreased bone mineral content, LUPRON DEPOT therapy may pose an additional risk. In endometrial patients, concomitant treatment with daily norethindrone acetate 5 mg should be considered and retreatment beyond an initial 6-month course is not advisable. In patients who are candidates for retreatment with LUPRON DEPOT, bone density should be assessed before retreatment and concomitant treatment with norethindrone acetate is recommended.
Hormonal add-back therapy: Norethindrone acetate is contraindicated in women with a history of thrombophlebitis, thromboembolic disorders, cerebral apoplexy, markedly impaired liver function or liver disease, or known or suspected carcinoma of the breast. Assessment and management of risk factors for cardiovascular disease is recommended prior to initiation of add-back therapy with norethindrone acetate and should be used with caution in women with risk factors, including lipid abnormalities or cigarette smoking. LUPRON DEPOT plus norethindrone acetate treatment should be discontinued if there is a sudden partial or complete loss of vision; if there is sudden onset of proptosis, diplopia, or migraine; or if examination reveals papilledema or retinal vascular lesions.
Advanced Prostate Cancer: Isolated cases of spinal cord compression or ureteral obstruction, which may contribute to paralysis with or without fatal complications, have been reported in patients with vertebral or ureteral metastasis using LUPRON DEPOT. Hyperglycemia and increased risk of developing diabetes, myocardial infarction, sudden cardiac death, and stroke have been reported in men receiving a GnRH agonist. Use of LUPRON DEPOT may prolong the QT/QTc interval. The benefits and risks of therapy should be carefully considered in patients with prior cardiac conditions or electrolyte abnormalities or in those taking drugs known to prolong the QT interval. Monitor patients for hyperglycemia, diabetes, and cardiovascular disease during treatment.
Central Precocious Puberty: Increased clinical signs and symptoms of puberty may occur during the early phase of LUPRON DEPOT-PED therapy. Monitor response and continued adequate suppression following initiation of therapy, dosing change, or as judged clinically appropriate. LUPRON DEPOT-PED in children under 2 years of age is not recommended. Psychiatric events such as emotional lability, crying, irritability, impatience, anger, and aggression have been reported in patients taking GnRH agonists, including LUPRON DEPOT-PED. Monitor for development or worsening of psychiatric symptoms during treatment.