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adverse reactions
ADVERSE REACTIONS Clinical Trials In the majority of patients testosterone levels increased above baseline during the first week, declining thereafter to baseline levels or below by the end of the second week of treatment. Potential exacerbations of signs and symptoms during the first few weeks of treatment is a concern in patients with vertebral metastases and/or urinary obstruction or hematuria which, if aggravated, may lead to neurological problems such as temporary weakness and/or paresthesia of the lower limbs or worsening of urinary symptoms (see WARNINGS section). In two clinical trials of LUPRON DEPOT–3 Month 22.5 mg, the following adverse reactions were reported to have a possible or probable relationship to drug as ascribed by the treating physician in 5% or more of the patients receiving the drug. Often, causality is difficult to assess in patients with metastatic prostate cancer. Reactions considered not drug-related are excluded. LUPRON DEPOT–3 Month 22.5 mg N=94 (%) Body As A Whole Asthenia 7 (7.4) General Pain 25 (26.6) Headache 6 (6.4) Injection Site Reaction 13 (13.8) Cardiovascular System Hot flashes/Sweats * 55 (58.5) Digestive System GI Disorders 15 (16.0) Musculoskeletal System Joint Disorders 11 (11.7) Central/Peripheral Nervous System Dizziness/Vertigo 6 (6.4) Insomnia/Sleep Disorders 8 (8.5) Neuromuscular Disorders 9 (9.6) Respiratory System Respiratory Disorders 6 (6.4) Skin and Appendages Skin Reaction 8 (8.5) Urogenital System Testicular Atrophy * 19 (20.2) Urinary Disorders 14 (14.9) In these same studies, the following adverse reactions were reported in less than 5% of the patients on LUPRON DEPOT–3 Month 22.5 mg. Body As A Whole - Enlarged abdomen, Fever; Cardiovascular System - Arrhythmia, Bradycardia, Heart failure, Hypertension, Hypotension, Varicose vein; Digestive System - Anorexia, Duodenal ulcer, Increased appetite, Thirst/dry mouth; Hemic and Lymphatic System - Anemia, Lymphedema; Metabolic and Nutritional Disorders - Dehydration, Edema; Central/Peripheral Nervous System - Anxiety, Delusions, Depression, Hypesthesia, Libido decreased * , Nervousness, Paresthesia; Respiratory System - Epistaxis, Pharyngitis, Pleural effusion, Pneumonia; Special Senses - Abnormal vision, Amblyopia, Dry eyes, Tinnitus; Urogenital System - Gynecomastia, Impotence * , Penis disorders, Testis disorders. * Physiologic effect of decreased testosterone. Laboratory Abnormalities of certain parameters were observed, but are difficult to assess in this population. The following were recorded in ≥5% of patients: Increased BUN, Hyperglycemia, Hyperlipidemia (total cholesterol, LDL-cholesterol, triglycerides), Hyperphosphatemia, Abnormal liver function tests, Increased PT, Increased PTT. Additional laboratory abnormalities reported were: Decreased platelets, Decreased potassium and Increased WBC. Postmarketing During postmarketing surveillance, which includes other dosage forms and other patient populations, the following adverse events were reported. Symptoms consistent with an anaphylactoid or asthmatic process have been rarely (incidence rate of about 0.002%) reported. Rash, urticaria, and photosensitivity reactions have also been reported. Localized reactions including induration and abscess have been reported at the site of injection. Symptoms consistent with fibromyalgia (eg, joint and muscle pain, headaches, sleep disorders, gastrointestinal distress, and shortness of breath) have been reported individually and collectively. Cardiovascular System – Hypotension, Myocardial infarction, Pulmonary embolism; Hemic and Lymphatic System - Decreased WBC; Central/Peripheral Nervous System - Convulsion, Peripheral neuropathy, Spinal fracture/paralysis; Endocrine System – Diabetes; Musculoskeletal System - Tenosynovitis-like symptoms; Urogenital System - Prostate pain. Changes in Bone Density: Decreased bone density has been reported in the medical literature in men who have had orchiectomy or who have been treated with an LH-RH agonist analog. In a clinical trial, 25 men with prostate cancer, 12 of whom had been treated previously with leuprolide acetate for at least six months, underwent bone density studies as a result of pain. The leuprolide-treated group had lower bone density scores than the nontreated control group. It can be anticipated that long periods of medical castration in men will have effects on bone density. 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 women and pediatric populations.