LUPRON DEPOT® (leuprolide acetate for depot suspension)
LUPRON DEPOT 3.75 mg and 3-month 11.25 mg are indicated for the management of endometriosis, including pain relief and reduction of endometriotic lesions.
LUPRON DEPOT 7.5 mg for 1-month, 22.5 mg for 3-month, 30 mg for
LUPRON DEPOT-PED® (leuprolide acetate for depot suspension)
General Information: LUPRON DEPOT, including
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.
References: 1. LUPRON DEPOT [package insert]. North Chicago, IL: AbbVie Inc.
2. LUPRON DEPOT-PED [package insert]. North Chicago, IL: AbbVie Inc.