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warnings and cautions
5 WARNINGS AND PRECAUTIONS An increase in clinical signs and symptoms of puberty may be observed during the first 2-4 weeks of therapy since gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug before being suppressed. (5.1) Convulsions have been observed in patients with or without a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications that have been associated with convulsions. (5.2) 5.1 Initial Rise of Gonadotropins and Sex Steroid Levels During the early phase of therapy, gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug. Therefore, an increase in clinical signs and symptoms of puberty may be observed [see Clinical Pharmacology (12.3) ] . 5.2 Convulsions Postmarketing reports of convulsions have been observed in patients on leuprolide acetate therapy. These included patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs. Convulsions have also been reported in patients in the absence of any of the conditions mentioned above. 5.3 Monitoring and Laboratory Tests Response to LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration should be monitored with a GnRHa stimulation test, basal LH or serum concentration of sex steroid levels at months 2-3, month 6 and further as judged clinically appropriate, to ensure adequate suppression. Additionally, height (for calculation of growth rate) and bone age should be assessed every 6-12 months. Once a therapeutic dose has been established, gonadotropin and/or sex steroid levels will decline to prepubertal levels. Gonadotropins and/or sex steroids may increase or rise above prepubertal levels if the dose is inadequate. Noncompliance with drug regimen or inadequate dosing may result in inadequate control of the pubertal process with gonadotropins and/or sex steroids increasing above prepubertal levels [see Clinical Studies (14) and Adverse Reactions (6) ] .
6 ADVERSE REACTIONS The most common adverse reactions with GnRH agonists including LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration are injection site reactions/pain including abscess, general pain, headache, emotional lability and hot flushes/sweating. During the early phase of therapy, gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug (hormonal flare effect). Therefore, an increase in clinical signs and symptoms of puberty may be observed [see Warnings and Precautions (5.1) ] . In clinical studies for LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration, the most frequent (≥2 patients) adverse reactions were: injection site pain, weight increased, headache, mood altered, and injection site swelling. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-Month Administration - Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Table 1. Percentage of Patients with Treatment-Emergent Adverse Reactions Occurring in ≥2 Pediatric Patients Receiving LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-Month Administration. 11.25 mg every 3 Months N=42 30 mg every 3 Months N=42 Overall N = 84 N % N % N % Injection site pain 8 (19) 9 (21) 17 (20) Weight increased 3 (7) 3 (7) 6 (7) Headache 1 (2) 3 (7) 4 (5) Mood altered 2 (5) 2 (5) 4 (5) Injection site swelling 1 (2) 1 (2) 2 (2) Less Common Adverse Reactions The following treatment-emergent adverse reactions were reported in one patient and are listed below by system organ class: Gastrointestinal Disorders – abdominal pain, nausea; General Disorders and Administration Site Conditions – asthenia, gait disturbance, injection site abscess sterile, injection site hematoma, injection site induration, injection site warmth, irritability; Metabolic and Nutritional Disorders – decreased appetite, obesity; Musculoskeletal and Connective Tissue Disorders - musculoskeletal pain, pain in extremity; Nervous System Disorders – crying, dizziness; Psychiatric Disorders – tearfulness; Respiratory, Thoracic and Mediastinal Disorders – cough; Skin and Subcutaneous Tissue Disorders – hyperhidrosis; Vascular Disorders – pallor. 6.2 Postmarketing The following adverse events have been observed with this or other formulations of leuprolide acetate injection. As leuprolide has multiple indications, and therefore patient populations, some of these adverse events may not be applicable to every patient. Allergic reactions (anaphylactic, rash, urticaria, and photosensitivity reactions) have also been reported. Gastrointestinal Disorders : nausea, abdominal pain, vomiting; General Disorders and Administration Site Conditions : chest pain, injection site reactions including induration and abscess have been reported; Investigations : decreased WBC, weight increased; Metabolism and Nutrition Disorders : diabetes mellitus; Musculoskeletal and Connective Tissue Disorders : tenosynovitis-like symptoms; Nervous System Disorders : neuropathy peripheral, convulsion, spinal fracture/paralysis; Skin and Subcutaneous Tissue Disorders : hot flush, flushing, hyperhidrosis; Reproductive System and Breast Disorders : prostate pain; Vascular Disorders : hypertension, hypotension. Pituitary apoplexy: During post-marketing surveillance, rare cases of pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) have been reported after the administration of gonadotropin-releasing hormone agonists. In a majority of these cases, a pituitary adenoma was diagnosed, with a majority of pituitary apoplexy cases occurring within 2 weeks of the first dose, and some within the first hour. In these cases, pituitary apoplexy has presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention has been required. See other LUPRON DEPOT and LUPRON Injection package inserts for other events reported in different patient populations.