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adverse reactions
6 ADVERSE REACTIONS The following is discussed in more detail in other sections of the labeling: Tumor Flare [see Warnings and Precautions ( 5.1 )] Metabolic Syndrome [see Warnings and Precautions ( 5.2 )] Cardiovascular Disease [see Warnings and Precautions ( 5.3 )] Effect on QT/QTc Interval [see Warnings and Precautions ( 5.4 )] Convulsions [see Warnings and Precautions ( 5.5 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.6 )] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. LUPRON DEPOT 7.5 mg for 1-month administration: The most common adverse reactions (>10%) were general pain, hot flashes/sweats, GI disorders, edema, respiratory disorder, urinary disorder. ( 6.1 ) LUPRON DEPOT 22.5 mg for 3-month administration: The most common adverse reactions (>10%) were general pain, injection site reaction, hot flashes/sweats, GI disorders, joint disorders, testicular atrophy, urinary disorders. ( 6.2 ) LUPRON DEPOT 30 mg for 4-month administration: The most common adverse reactions (>10%) were asthenia, flu syndrome, general pain, headache, injection site reaction, hot flashes/sweats, GI disorders, edema, skin reaction, urinary disorders. ( 6.3 ) LUPRON DEPOT 45 mg for 6-month administration: The most common adverse reactions (>10%) were hot flush, injection site pain, upper respiratory infection, and fatigue. ( 6.4 ) In postmarketing experience, mood swings, depression, rare reports of suicidal ideation and attempt, rare reports of pituitary apoplexy, and rare reports of serious drug-induced liver injury have been reported. ( 6.5 ) 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 7.5 mg for 1-Month Administration 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 and Precautions ( 5.1 )] . In a clinical trial of LUPRON DEPOT 7.5 mg for 1-month administration, the following adverse reactions were reported in 5% or more of the patients during the initial 24-week treatment period. Table 2. Adverse Reactions Reported in ≥ 5% of Patients LUPRON DEPOT 7.5 mg for 1-Month Administration (N=56) N (%) Body As A Whole General pain 13 (23.2) Infection 3 (5.4) Cardiovascular System Hot flashes/sweats* 32 (57.1) Digestive System GI disorders 8 (14.3) Metabolic and Nutritional Disorders Edema 8 (14.3) Nervous System Libido decreased* 3 (5.4) Respiratory System Respiratory disorder 6 (10.7) Urogenital System Urinary disorder 7 (12.5) Impotence* 3 (5.4) Testicular atrophy* 3 (5.4) * Due to the expected physiologic effect of decreased testosterone levels. In this same study, the following adverse reactions were reported in less than 5% of the patients on LUPRON DEPOT 7.5 mg for 1-month administration. Body As A Whole - asthenia, cellulitis, fever, headache, injection site reaction, neoplasm Cardiovascular System - angina, congestive heart failure Digestive System - anorexia, dysphagia, eructation, peptic ulcer Blood and Lymphatic System - ecchymosis Musculoskeletal System - myalgia Nervous System - agitation, insomnia/sleep disorders, neuromuscular disorders Respiratory System - emphysema, hemoptysis, lung edema, sputum increased Skin and Appendages - hair disorder, skin reaction Urogenital System - balanitis, breast enlargement, urinary tract infection Laboratory Abnormalities Abnormalities of certain parameters were observed, but their relationship to drug treatment are difficult to assess in this population. The following were recorded in ≥5% of patients at final visit: Decreased albumin, decreased hemoglobin/hematocrit, decreased prostatic acid phosphatase, decreased total protein, decreased urine specific gravity, hyperglycemia, hyperuricemia, increased BUN, increased creatinine, increased liver function tests (AST, LDH), increased phosphorus, increased platelets, increased prostatic acid phosphatase, increased total cholesterol, increased urine specific gravity, leukopenia. 6.2 LUPRON DEPOT 22.5 mg for 3-Month Administration In two clinical trials of LUPRON DEPOT 22.5 mg for 3-month administration, 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. Table 3. Adverse Reactions Reported in ≥ 5% of Patients LUPRON DEPOT 22.5 mg for 3-Month Administration Body System/Reaction 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 22.5 mg for 3-month administration. 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 Blood 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 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. 6.3 LUPRON DEPOT 30 mg for 4-Month Administration The 4-month formulation of LUPRON DEPOT 30 mg was utilized in clinical trials that studied the drug in 49 nonorchiectomized prostate cancer patients for 32 weeks or longer and in 24 orchiectomized prostate cancer patients for 20 weeks. In the above described clinical trials, the following adverse reactions were reported in ≥ 5% of the patients during the treatment period. Table 4. Adverse Reactions Reported in ≥ 5% of Patients LUPRON DEPOT 30 mg for 4-Month Administration Body System/Events Nonorchiectomized Orchiectomized Study 013 Study 012 N=49 (%) N=24 (%) Body As A Whole Asthenia 6 (12.2) 1 (4.2) Flu syndrome 6 (12.2) 0 (0.0) General pain 16 (32.7) 1 (4.2) Headache 5 (10.2) 1 (4.2) Injection site reaction 4 (8.2) 9 (37.5) Cardiovascular System Hot flashes/sweats 23 (46.9) 2 (8.3) Digestive System GI disorders 5 (10.2) 3 (12.5) Metabolic and Nutritional Disorders Dehydration 4 (8.2) 0 (0.0) Edema 4 (8.2) 5 (20.8) Musculoskeletal System Joint disorder 8 (16.3) 1 (4.2) Myalgia 4 (8.2) 0 (0.0) Nervous System Dizziness/vertigo 3 (6.1) 2 (8.3) Neuromuscular disorders 3 (6.1) 1 (4.2) Paresthesia 4 (8.2) 1 (4.2) Respiratory System Respiratory disorder 4 (8.2) 1 (4.2) Skin and Appendages Skin reaction 6 (12.2) 0 (0.0) Urogenital System Urinary disorders 5 (10.2) 4 (16.7) In these same studies, the following adverse reactions were reported in less than 5% of the patients on LUPRON DEPOT 30 mg for 4-month administration. Body As A Whole - abscess, accidental injury, allergic reaction, cyst, fever, generalized edema, hernia, neck pain, neoplasm Cardiovascular System - atrial fibrillation, deep thrombophlebitis, hypertension Digestive System - anorexia, eructation, gastrointestinal hemorrhage, gingivitis, gum hemorrhage, hepatomegaly, increased appetite, intestinal obstruction, periodontal abscess Blood and Lymphatic System - lymphadenopathy Metabolic and Nutritional Disorders - healing abnormal, hypoxia, weight loss Musculoskeletal System - leg cramps, pathological fracture, ptosis Nervous System - abnormal thinking, amnesia, confusion, convulsion, dementia, depression, insomnia/sleep disorders, libido decreased*, neuropathy, paralysis Respiratory System - asthma, bronchitis, hiccup, lung disorder, sinusitis, voice alteration Skin and Appendages - herpes zoster, melanosis Urogenital System - bladder carcinoma, epididymitis, impotence*, prostate disorder, testicular atrophy*, urinary incontinence, urinary tract infection. * Physiologic effect of decreased testosterone. Laboratory Abnormalities Abnormalities of certain parameters were observed, but their relationship to drug treatment is difficult to assess in this population. The following were recorded in ≥ 5% of patients: decreased bicarbonate, decreased hemoglobin/hematocrit/RBC, hyperlipidemia (total cholesterol, LDL-cholesterol, triglycerides), decreased HDL-cholesterol, eosinophilia, increased glucose, increased liver function tests (ALT, AST, GGTP, LDH), increased phosphorus. Additional laboratory abnormalities were reported: increased BUN and PT, leukopenia, thrombocytopenia, uricaciduria. 6.4 LUPRON DEPOT 45 mg for 6-Month Administration One open label, multicenter study was conducted with LUPRON DEPOT 45 mg for 6-month administration in 151 prostate cancer patients. Patients were treated for 48 weeks, with 139/151 receiving two injections 24 weeks apart. In the above described clinical trial, the following adverse reactions were reported in ≥ 5% of the patients during the treatment period. The Table 5 includes all adverse reactions reported in ≥ 5% of patients as well as the incidences of these adverse reactions that were considered, by the treating physician, to have a definite or possible relationship to LUPRON DEPOT. Table 5. Adverse Reactions in ≥ 5% of Patients LUPRON DEPOT 45 mg for 6-Month Administration Treatment Emergent Treatment Related Adverse Event N = 151 (%) N = 151 (%) Hot flush/flushing 89 58.9 88 58.3 Injection site pain/discomfort 29 19.2 16 10.6 Upper respiratory tract infection/influenza-like illness 1 32 21.2 0 0 Fatigue/lethargy 20 13.2 18 11.9 Constipation 15 9.9 5 3.3 Arthralgia 14 9.3 2 1.3 Insomnia/sleep disorder 13 8.6 5 3.3 Headache/sinus headache 12 7.9 3 2.0 Musculoskeletal pain/ myalgia 12 7.9 3 2.0 Second primary neoplasm 2 11 7.3 0 0 Cough 10 6.6 2 1.3 Hematuria/hemorrhagic cystitis 10 6.6 0 0 Hypertension/BP increased 10 6.6 3 2.0 Rash 9 6.0 3 2.0 Dysuria 9 6.0 1 0.7 Urinary tract infection/cystitis 9 6.0 0 0 Anemia/hemoglobin decreased 10 6.6 2 1.3 Back pain 8 5.3 0 0 COPD 8 5.3 0 0 Dizziness 8 5.3 3 2.0 Dyspnea/dyspnea on exertion 8 5.3 2 1.3 Nocturia 8 5.3 2 1.3 Peripheral/pitting edema 8 5.3 2 1.3 Coronary artery disease/angina 8 5.3 1 0.7 1 Includes influenza, nasal congestion, nasopharyngitis, rhinorrhea, upper respiratory tract infection, and viral upper respiratory tract infection 2 Includes basal cell carcinoma, bladder transitional cell carcinoma, lung neoplasm, malignant melanoma, non-Hodgkin’s lymphoma, and squamous cell carcinoma The following adverse reactions led to discontinuation; fatigue, hot flush, second primary neoplasm, asthenia, coronary artery disease, constipation, hyperkalemia, and sleep disorder. Serious adverse reactions in ≥ 2% of patients, regardless of causality, included chronic obstructive pulmonary disease, coronary artery disease/angina, cerebrovascular accident/transient ischemic attack, pneumonia, and second primary neoplasms. Laboratory Abnormalities At baseline, 13.9% of patients had a CTCAE v4.0 grade 1 or 2 decreased hemoglobin. During the study, 42.4% of subjects had grade 1 decreased hemoglobin (10 - <12-5 g/dL), 2.0% had grade 2 ( 8 - <10 g/dL) and 1.3% of subjects had grade 3 or 4 (<8 g/dL). Likewise, 28.5% of patients had a grade 1 or 2 increased cholesterol at baseline while 55.0% had grade 1 increased cholesterol (>199- 300 mg/dL), 3.3% had a grade 2 increase (>300-400 mg/dL), and 0.7% of subjects had grade 3 (>400 mg/dL) during the study. 6.5 Postmarketing The following adverse reactions have been identified during post-approval use of LUPRON DEPOT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. During postmarketing surveillance, which includes other dosage forms and other patient populations, the following adverse reactions were reported. Mood swings, including depression, have been reported. There have been very rare reports of suicidal ideation and attempt. Many, but not all, of these patients had a history of depression or other psychiatric illness. Patients should be counseled on the possibility of development or worsening of depression during treatment with LUPRON DEPOT. Symptoms consistent with an anaphylactoid or asthmatic process have occurred (incidence rate of about 0.002%). 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 a GnRH 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 A poplexy - 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. Symptoms consistent with fibromyalgia (e.g., 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 Respiratory, T horacic and M ediastinal disorder - interstitial lung disease Hepato-biliary disorder - serious drug-induced liver injury, non-alcoholic fatty liver disease Skin reactions - rash, urticaria, photosensitivity, erythema multiforme, bullous dermatitis, dermatitis exfoliative, DRESS, SJS/ TEN, and AGEP Blood and Lymphatic System - decreased WBC Central/Peripheral Nervous System - convulsion, peripheral neuropathy, spinal fracture/paralysis Endocrine System - diabetes mellitus Musculoskeletal System - tenosynovitis-like symptoms Urogenital System - prostate pain General disorders and administration site conditions – injection site reactions including induration, abscess, and necrosis See other LUPRON DEPOT and LUPRON Injection prescribing information for other reactions reported in women and pediatric populations.