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adverse reactions
ADVERSE REACTIONS Dementia of the Alzheimer’s T ype Adverse Events Leading to Discontinuation The rate of discontinuation due to adverse events in controlled clinical trials of Exelon ® (rivastigmine tartrate) was 15% for patients receiving 6-12 mg/day compared to 5% for patients on placebo during forced weekly dose titration. While on a maintenance dose, the rates were 6% for patients on Exelon compared to 4% for those on placebo. The most common adverse events leading to discontinuation, defined as those occurring in at least 2% of patients and at twice the incidence seen in placebo patients, are shown in Table 1. Table 1. Most Frequent Adverse Events Leading to Withdrawal from Clinical Trials during Titration and Maintenance in Patients Receiving 6-12 mg/day Exelon ® Using a Forced-Dose Titration Study Phase Titration Maintenance Overall Placebo Exelon ® greater than or equal to 6-12 mg/day Placebo Exelon ® greater than or equal to 6-12 mg/day Placebo Exelon ® greater than or equal to 6-12 mg/day (n=868) (n=1,189) (n=788) (n=987) (n=868) (n=1,189) Event/% Discontinuing Nausea less than 1 8 less than 1 1 1 8 Vomiting less than 1 4 less than 1 1 less than 1 5 Anorexia 0 2 less than 1 1 less than 1 3 Dizziness less than 1 2 less than 1 1 less than 1 2 Most Frequent Adverse Clinical Events Seen in Association with the Use of Exelon The most common adverse events, defined as those occurring at a frequency of at least 5% and twice the placebo rate, are largely predicted by Exelon's cholinergic effects. These include nausea, vomiting, anorexia, dyspepsia, and asthenia. Gastrointestinal Adverse Reactions Exelon use is associated with significant nausea, vomiting, and weight loss (see WARNINGS). Adverse Events Reported in Controlled Trials Table 2 lists treatment-emergent signs and symptoms that were reported in at least 2% of patients in placebo-controlled trials and for which the rate of occurrence was greater for patients treated with Exelon doses of 6-12 mg/day than for those treated with placebo. The prescriber should be aware that these figures cannot be used to predict the frequency of adverse events in the course of usual medical practice when patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescriber with one basis by which to estimate the relative contribution of drug and non-drug factors to the adverse event incidences in the population studied. In general, adverse reactions were less frequent later in the course of treatment. No systematic effect of race or age could be determined from the incidence of adverse events in the controlled studies. Nausea, vomiting and weight loss were more frequent in women than men. Table 2. Adverse Events Reported in Controlled Clinical Trials in at Least 2% of Patients Receiving Exelon ® (6-12 mg/day) and at a Higher Frequency than Placebo-treated Patients Body System/Adverse Event Placebo (n=868) Exelon ® (6-12 mg/day) (n=1,189) Percent of Patients with any Adverse Event 79 92 Autonomic Nervous System Sweating Increased 1 4 Syncope 2 3 Body as a Whole Accidental Trauma 9 10 Fatigue 5 9 Asthenia 2 6 Malaise 2 5 Influenza-like Symptoms 2 3 Weight Decrease less than 1 3 Cardiovascular Disorders, General Hypertension 2 3 Central and Peripheral Nervous System Dizziness 11 21 Headache 12 17 Somnolence 3 5 Tremor 1 4 Gastrointestinal System Nausea 12 47 Vomiting 6 31 Diarrhea 11 19 Anorexia 3 17 Abdominal Pain 6 13 Dyspepsia 4 9 Constipation 4 5 Flatulence 2 4 Eructation 1 2 Psychiatric Disorders Insomnia 7 9 Confusion 7 8 Depression 4 6 Anxiety 3 5 Hallucination 3 4 Aggressive Reaction 2 3 Resistance Mechanism Disorders Urinary Tract Infection 6 7 Respiratory System Rhinitis 3 4 Other adverse events observed at a rate of 2% or more on Exelon 6-12 mg/day but at a greater or equal rate on placebo were chest pain, peripheral edema, vertigo, back pain, arthralgia, pain, bone fracture, agitation, nervousness, delusion, paranoid reaction, upper respiratory tract infection, infection (general), coughing, pharyngitis, bronchitis, rash (general), urinary incontinence. Dementia Associated with Parkinson’s D isease Adverse Events L eading to D iscontinuation The rate of discontinuation due to adverse events in the single controlled trial of Exelon (rivastigmine tartrate) was 18.2% for patients receiving 3-12 mg/day compared to 11.2% for patients on placebo during the 24-week study. The most frequent adverse events that led to discontinuation from this study, defined as those occurring in at least 1% of patients receiving Exelon and more frequent than those receiving placebo, were nausea (3.6% Exelon vs. 0.6% placebo), vomiting (1.9% Exelon vs. 0.6% placebo), and tremor (1.7% Exelon vs. 0.0% placebo). Most Frequent Adverse Clinical Events Seen in Association with the Use of Exelon The most common adverse events, defined as those occurring at a frequency of at least 5% and twice the placebo rate, are largely predicted by Exelon's cholinergic effects. These include nausea, vomiting, tremor, anorexia, and dizziness. Adverse Events Reported in Controlled Trials Table 3 lists treatment-emergent signs and symptoms that were reported in at least 2% of patients in placebo-controlled trials and for which the rate of occurrence was greater for patients treated with Exelon doses of 3-12 mg/day than for those treated with placebo. The prescriber should be aware that these figures cannot be used to predict the frequency of adverse events in the course of usual medical practice when patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescriber with one basis by which to estimate the relative contribution of drug and non-drug factors to the adverse event incidences in the population studied. In general, adverse reactions were less frequent later in the course of treatment. Table 3. Adverse Events Reported in the Single Controlled Clinical Trial in at Least 2% of Patients Receiving Exelon ® (3-12 mg/day) and at a Higher Frequency than Placebo-treated Patients Body System/Adverse Event Placebo (n=179) Exelon ® (3-12 mg/day) (n=362) Percent of Patients with any Adverse Event 71 84 Gastrointestinal D isorders Nausea 11 29 Vomiting 2 17 Diarrhea 4 7 Upper Abdominal Pain 1 4 General Disorders and A dministrative S ite C onditions Fatigue 3 4 Asthenia 1 2 Metabolism and N utritional D isorders Anorexia 3 6 Dehydration 1 2 Nervous S ystem D isorders Tremor 4 10 Dizziness 1 6 Headache 3 4 Somnolence 3 4 Parkinson’s Disease (worsening) 1 3 Parkinsonism 1 2 Psychiatric Disorders Anxiety 1 4 Insomnia 2 3 Other Adverse Events Observed During Clinical Trials Dementia of the Alzheimer’s T ype Exelon has been administered to over 5,297 individuals during clinical trials worldwide. Of these, 4,326 patients have been treated for at least 3 months, 3,407 patients have been treated for at least 6 months, 2,150 patients have been treated for 1 year, 1,250 patients have been treated for 2 years, and 168 patients have been treated for over 3 years. With regard to exposure to the highest dose, 2,809 patients were exposed to doses of 10-12 mg, 2,615 patients treated for 3 months, 2,328 patients treated for 6 months, 1,378 patients treated for 1 year, 917 patients treated for 2 years, and 129 patients treated for over 3 years. Treatment-emergent signs and symptoms that occurred during 8 controlled clinical trials and 9 open-label trials in North America, Western Europe, Australia, South Africa, and Japan were recorded as adverse events by the clinical investigators using terminology of their own choosing. To provide an overall estimate of the proportion of individuals having similar types of events, the events were grouped into a smaller number of standardized categories using a modified WHO dictionary, and event frequencies were calculated across all studies. These categories are used in the listing below. The frequencies represent the proportion of 5,297 patients from these trials who experienced that event while receiving Exelon. All adverse events occurring in at least 6 patients (approximately 0.1%) are included, except for those already listed elsewhere in labeling, WHO terms too general to be informative, relatively minor events, or events unlikely to be drug-caused. Events are classified by body system and listed using the following definitions: frequent adverse events – those occurring in at least 1/100 patients; infrequent adverse events – those occurring in 1/100 to 1/1,000 patients. These adverse events are not necessarily related to Exelon treatment and in most cases were observed at a similar frequency in placebo-treated patients in the controlled studies. Autonomic Nervous System: Infrequent: Cold clammy skin, dry mouth, flushing, increased saliva. Body as a Whole: Frequent: Accidental trauma, fever, edema, allergy, hot flushes, rigors. Infrequent: Edema periorbital or facial, hypothermia, edema, feeling cold, halitosis. Cardiovascular System: Frequent: Hypotension, postural hypotension, cardiac failure. Central and Peripheral Nervous System: Frequent: Abnormal gait, ataxia, paresthesia, convulsions. Infrequent: Paresis, apraxia, aphasia, dysphonia, hyperkinesia, hyperreflexia, hypertonia, hypoesthesia, hypokinesia, migraine, neuralgia, nystagmus, peripheral neuropathy. Endocrine System: Infrequent: Goiter, hypothyroidism. Gastrointestinal System: Frequent: Fecal incontinence, gastritis. Infrequent: Dysphagia, esophagitis, gastric ulcer, gastroesophageal reflux, GI hemorrhage, hernia, intestinal obstruction, melena, rectal hemorrhage, gastroenteritis, ulcerative stomatitis, duodenal ulcer, hematemesis, gingivitis, tenesmus, pancreatitis, colitis, glossitis. Hearing and Vestibular Disorders: Frequent: Tinnitus. Heart Rate and Rhythm Disorders: Frequent: Atrial fibrillation, bradycardia, palpitation. Infrequent: AV block, bundle branch block, sick sinus syndrome, cardiac arrest, supraventricular tachycardia, extrasystoles, tachycardia. Liver and Biliary System Disorders: Infrequent: Abnormal hepatic function, cholecystitis. Metabolic and Nutritional Disorders: Frequent: Dehydration, hypokalemia. Infrequent: Diabetes mellitus, gout, hypercholesterolemia, hyperlipemia, hypoglycemia, cachexia, thirst, hyperglycemia, hyponatremia. Musculoskeletal Disorders: Frequent: Arthritis, leg cramps, myalgia. Infrequent: Cramps, hernia, muscle weakness. Myo-, Endo-, Pericardial and Valve Disorders: Frequent: Angina pectoris, myocardial infarction. Platelet, Bleeding, and Clotting Disorders: Frequent: Epistaxis. I nfrequent: Hematoma, thrombocytopenia, purpura. Psychiatric Disorders: Frequent: Paranoid reaction, confusion. Infrequent: Abnormal dreaming, amnesia, apathy, delirium, dementia, depersonalization, emotional lability, impaired concentration, decreased libido, personality disorder, suicide attempt, increased libido, neurosis, suicidal ideation, psychosis. Red Blood Cell Disorders: Frequent: Anemia. Infrequent: Hypochromic anemia. Reproductive Disorders (Female and Male): Infrequent: Breast pain, impotence, atrophic vaginitis. Resistance Mechanism Disorders: Infrequent: Cellulitis, cystitis, herpes simplex, otitis media. Respiratory System: Infrequent: Bronchospasm, laryngitis, apnea. Skin and Appendages: Frequent: Rashes of various kinds (maculopapular, eczema, bullous, exfoliative, psoriaform, erythematous). Infrequent: Alopecia, skin ulceration, urticaria, contact dermatitis. Special Senses: Infrequent: Perversion of taste, loss of taste. Urinary System Disorders: Frequent: Hematuria. Infrequent: Albuminuria, oliguria, acute renal failure, dysuria, micturition urgency, nocturia, polyuria, renal calculus, urinary retention. Vascular (extracardiac) Disorders: Infrequent: Hemorrhoids, peripheral ischemia, pulmonary embolism, thrombosis, deep thrombophlebitis, aneurysm, intracranial hemorrhage. Vision Disorders: Frequent: Cataract. Infrequent: Conjunctival hemorrhage, blepharitis, diplopia, eye pain, glaucoma. White Cell and Resistance Disorders: Infrequent: Lymphadenopathy, leukocytosis. Dementia Associated with Parkinson’s D isease Exelon has been administered to 485 individuals during clinical trials worldwide. Of these, 413 patients have been treated for at least 3 months, 253 patients have been treated for at least 6 months, and 113 patients have been treated for 1 year. Additional treatment-emergent adverse events in patients with Parkinson’s disease dementia occurring in at least 1 patient (approximately 0.3%) are listed below, excluding events that are already listed above for the dementia of the Alzheimer’s type or elsewhere in labeling, WHO terms too general to be informative, relatively minor events, or events unlikely to be drug-caused. Events are classified by body system and listed using the following definitions: frequent adverse events – those occurring in at least 1/100 patients; infrequent adverse events – those occurring in 1/100 to 1/1,000 patients. These adverse events are not necessarily related to Exelon treatment and in most cases were observed at a similar frequency in placebo-treated patients in the controlled studies. Cardiovascular System: Frequent: Chest pain. Infrequent: Sudden cardiac death. Central and Peripheral Nervous System: Frequent: Dyskinesia, bradykinesia, restlessness, transient ischemic attack. Infrequent: Dystonia, hemiparesis, epilepsy, restless leg syndrome. Endocrine System: Infrequent: Elevated prolactin level. Gastrointestinal System: Frequent: Dyspepsia. Infrequent: Fecaloma, dysphagia, diverticulitis, peritonitis. Hearing and Vestibular Disorders: Frequent: Vertigo. Infrequent: Meniere’s disease. Heart Rate and Rhythm Disorders: Infrequent: Adam-Stokes syndrome. Liver and Biliary System Disorders: Infrequent: Elevated alkaline phosphatase level, elevated gamma-glutamyltransferase level. Musculoskeletal Disorders: Frequent: Back pain. Infrequent: Muscle stiffness, myoclonus, freezing phenomenon. Psychiatric Disorders: Frequent: Agitation, depression. Infrequent: Delusion, insomnia. Reproductive Disorders (Female and Male): Infrequent: endometrial hypertrophy, mastitis, prostatic adenoma. Respiratory System: Frequent: Dyspnea. Infrequent: Cough. Urinary System Disorders: Infrequent: Urinary incontinence, neurogenic bladder. Vascular (extracardiac) Disorders: Infrequent: Vasovagal syncope, vasculitis. Vision Disorders: Infrequent: Blurred vision, blepharospasm, conjunctivitis, retinopathy. Post-Introduction Reports Voluntary reports of adverse events temporally associated with Exelon that have been received since market introduction that are not listed above, and that may or may not be causally related to the drug include the following: Skin and Appendages: Stevens-Johnson syndrome.