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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. This transient increase was occasionally associated with a temporary worsening of signs and symptoms, usually manifested by an increase in bone pain (see WARNINGS section). In a few cases a temporary worsening of existing hematuria and urinary tract obstruction occurred during the first week. Temporary weakness and paresthesia of the lower limbs have been reported in a few cases. 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 which, if aggravated, may lead to neurological problems or increase the obstruction. In a comparative trial of LUPRON INJECTION (leuprolide acetate) versus DES, in 5% or more of the patients receiving either drug, the following adverse reactions were reported to have a possible or probable relationship to drug as ascribed by the treating physician. Often, causality is difficult to assess in patients with metastatic prostate cancer. Reactions considered not drug related are excluded. LUPRON (N=98) DES (N=101) Number of Reports Cardiovascular System Congestive heart failure 1 5 ECG changes/ischemia 19 22 High blood pressure 8 5 Murmur 3 8 Peripheral edema 12 30 Phlebitis/thrombosis 2 10 Gastrointestinal System Anorexia 6 5 Constipation 7 9 Nausea/vomiting 5 17 Endocrine System *Decreased testicular size 7 11 *Gynecomastia/breast tenderness or pain 7 63 *Hot flashes 55 12 *Impotence 4 12 Hemic and Lymphatic System Anemia 5 5 Musculoskeletal System Bone pain 5 2 Myalgia 3 9 Central/Peripheral Nervous System Dizziness/lightheadedness 5 7 General pain 13 13 Headache 7 4 Insomnia/sleep disorders 7 5 Respiratory System Dyspnea 2 8 Sinus congestion 5 6 Integumentary System Dermatitis 5 8 Urogenital System Frequency/urgency 6 8 Hematuria 6 4 Urinary tract infection 3 7 Miscellaneous Asthenia 10 10 * Physiologic effect of decreased testosterone. In this same study, the following adverse reactions were reported in less than 5% of the patients on LUPRON. Cardiovascular System —Angina, Cardiac arrhythmias, Myocardial infarction, Pulmonary emboli; Gastrointestinal System —Diarrhea, Dysphagia, Gastrointestinal bleeding, Gastrointestinal disturbance, Peptic ulcer, Rectal polyps; Endocrine System —Libido decrease, Thyroid enlargement; Musculoskeletal System —Joint pain; Central/Peripheral Nervous System —Anxiety, Blurred vision, Lethargy, Memory disorder, Mood swings, Nervousness, Numbness, Paresthesia, Peripheral neuropathy, Syncope/blackouts, Taste disorders; Respiratory System —Cough, Pleural rub, Pneumonia, Pulmonary fibrosis; Integumentary System —Carcinoma of skin/ear, Dry skin, Ecchymosis, Hair loss, Itching, Local skin reactions, Pigmentation, Skin lesions; Urogenital System —Bladder spasms, Dysuria, Incontinence, Testicular pain, Urinary obstruction; Miscellaneous —Depression, Diabetes, Fatigue, Fever/chills, Hypoglycemia, Increased BUN, Increased calcium, Increased creatinine, Infection/inflammation, Ophthalmologic disorders, Swelling (temporal bone). In an additional clinical trial and from long-term observation of both studies, the following additional adverse events (excluding those considered not drug related) were reported for patients receiving LUPRON. Cardiovascular System —Bradycardia, Carotid bruit, Extrasystole, Palpitations, Perivascular cuffing (eyes), Ruptured aortic aneurysm, Stroke, Tachycardia, Transient ischemic attack; Gastrointestinal System —Flatus, Dryness of mouth and throat, Hepatitis, Hepatomegaly, Occult blood (rectal exam), Rectal fistula/erythema; Endocrine System —Libido increase, Thyroid nodule; Musculoskeletal System —Ankylosing spondylosis, Arthritis, Blurred disc margins, Bone fracture, Muscle stiffness, Muscle tenderness, Pelvic fibrosis, Spasms/cramps; Central/Peripheral Nervous System —Auditory hallucinations/tinnitus, Decreased hearing, Decreased reflexes, Euphoria, Hyperreflexia, Loss of smell, Motor deficiency; Respiratory System —Chest tightness, Decreased breathing sounds, Hemoptysis, Pleuritic chest pain, Pulmonary infiltrate, Rales/rhonchi, Rhinitis, Strep throat, Wheezing/bronchitis; Integumentary System —Boil (pubic), Bruises, Hives, Keratosis, Mole, Shingles, Spiders; Urogenital System — Blisters on penis, Inguinal hernia, Penile swelling, Post void residual, Prostatic pain, Pyuria; Miscellaneous —Abdominal distention, Facial swelling/edema, Feet burning, Flu, Eyelid growth, Hypoproteinemia, Accidental injury, Knee effusion, Mass, Pallid, Sallow, Weakness. 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 (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; Endocrine System - Diabetes; Gastrointestinal System - Hepatic dysfunction; Hemic and Lymphatic System - Decreased WBC; Integumentary System - Hair growth; Central/Peripheral Nervous System - Convulsion, Spinal fracture/paralysis, Hearing disorder; Miscellaneous - Hard nodule in throat, Weight gain, Increased uric acid; Musculoskeletal System - Tenosynovitis-like symptoms; Respiratory System - Respiratory disorders. 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 the same and different patient populations.
adverse reactions
ADVERSE REACTIONS Clinical Trials: Potential exacerbation of signs and symptoms during the first few weeks of treatment (see PRECAUTIONS section) is a concern in patients with rapidly advancing central precocious puberty. In two studies of children with central precocious puberty, in 2% or more of the patients receiving the drug, the following adverse reactions were reported to have a possible or probable relationship to drug as ascribed by the treating physician. Reactions considered not drug related are excluded. Number of Patients N = 421 (Percent) Body as a Whole General Pain 12 (3) Headache 11 (3) Injection Site Reactions Including Abscess* 37 (9) Cardiovascular System Vasodilation 9 (2) Integumentary System (Skin and Appendages) Acne/Seborrhea 13 (3) Rash Including Erythema Multiforme 12 (3) Psychiatric System Emotional Lability 19 (5) Urogenital System Vaginitis/Vaginal Bleeding/Vaginal Discharge 13 (3) * Most events were mild or moderate in severity. In those same studies, the following adverse reactions were reported in less than 2% of the patients. Body as a Whole - Aggravation of preexisting tumor and decreased vision, Allergic Reaction, Body Odor, Fever, Flu Syndrome, Hypertrophy, Infection; Cardiovascular System - Bradycardia, Hypertension, Peripheral Vascular Disorder, Syncope; Digestive System - Constipation, Dyspepsia, Dysphagia, Gingivitis, Increased Appetite, Nausea/Vomiting; Endocrine System - Accelerated Sexual Maturity, Feminization, Goiter; Hemic and Lymphatic System - Purpura; Metabolic and Nutritional Disorders - Growth Retarded, Peripheral Edema, Weight Gain; Musculoskeletal System - Arthralgia, Joint Disorder, Myalgia, Myopathy; Nervous System - Hyperkinesia, Somnolence; Psychiatric System - Depression, Nervousness; Respiratory System - Asthma, Epistaxis, Pharyngitis, Rhinitis, Sinusitis; Integumentary System (Skin and Appendages) - Alopecia, Hair Disorder, Hirsutism, Leukoderma, Nail Disorder, Skin Hypertrophy; Urogenital System - Cervix Disorder/Neoplasm, Dysmenorrhea, Gynecomastia/Breast Disorders, Menstrual Disorder, Urinary Incontinence. Laboratory: The following laboratory events were reported as adverse reactions, antinuclear antibody present and increased sedimentation rate. 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 (e.g., joint and muscle pain, headaches, sleep disorders, gastrointestinal distress, and shortness of breath) have been reported individually and collectively. Cardiovascular System – Hypotension, Pulmonary embolism; Gastrointestinal System – Hepatic dysfunction; Hemic and Lymphatic System – Decreased WBC; Integumentary System – Hair growth; Psychiatric adverse events: Emotional lability, such as crying, irritability, impatience, anger, and aggression, has been observed with GnRH agonists, including leuprolide acetate (see WARNINGS ); Depression, including rare reports of suicidal ideation and attempt, has been reported for GnRH agonists, including leuprolide acetate, in children treated for central precocious puberty. Many, but not all, of these patients had a history of psychiatric illness or other comorbidities with an increased risk of depression. Central/Peripheral Nervous System – Peripheral neuropathy, Convulsion, Spinal fracture/paralysis, Hearing disorder; Miscellaneous – Hard nodule in throat, Weight gain, Increased uric acid; Musculoskeletal System – Tenosynovitis-like symptoms; Respiratory System – Respiratory disorders; 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. The effects on bone density in children are unknown. 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 INJECTION and LUPRON DEPOT package inserts for adverse events reported in other patient populations.