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adverse reactions
6 ADVERSE REACTIONS The most commonly reported adverse reactions are headache (1.8%) and nausea (1.6%). (6) To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc. at 1-800-257-8151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience 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. Adult In clinical trials, a total of 2982 adult subjects (119 healthy volunteers and 2863 patients) received MultiHance at doses ranging from 0.005 to 0.4 mmol/kg. There were 1724 (58%) men and 1258 (42%) women with a mean age of 55.1 years (range 18 to 92 years). A total of 2644 (89%) subjects were Caucasian, 84 (3%) Black, 162 (5%) Asian, 29 (1%) Hispanic, 18 (1%) in other racial groups, and for 45 (2%) subjects, race was not reported. The most commonly reported adverse reactions in adult subjects who received MultiHance were headache (1.8%) and nausea (1.6%). Most adverse reactions were mild to moderate in intensity. Four subjects experienced serious adverse reactions. One subject with a history of seizures experienced convulsions 17 minutes after the administration of MultiHance. Another subject with a history of recent myocardial infarction (MI) and congestive heart failure (CHF) experienced acute pulmonary edema within 10 minutes after the administration of 30 mL of MultiHance. The third subject developed acute necrotizing pancreatitis. The fourth subject experienced an anaphylactoid reaction with laryngismus and dyspnea [ see Warnings and Precautions (5.1) ]. Adverse reactions that occurred in at least 0.5% of 2982 adult subjects who received MultiHance are listed below (Table 1), in decreasing order of occurrence within each system. TABLE 1: ADVERSE REACTIONS REPORTED IN ≥ 0.5% OF ADULT SUBJECTS WHO RECEIVED MultiHance IN CLINICAL TRIALS Number of subjects dosed 2982 Number of subjects with any adverse reaction 450 (15.1%) Gastrointestinal Disorders Nausea 48 (1.6%) Vomiting 14 (0.5%) General Disorders and Administration Site Disorders Feeling Hot 31 (1.0%) Injection Site Reaction 40 (1.3%) Nervous System Disorders Headache 54 (1.8%) Taste perversion 25 (0.8%) Paresthesia 23 (0.8%) Dizziness 22 (0.7%) Skin and Subcutaneous Tissue Disorders Rash 19 (0.6%) Vascular Disorders Hypertension 16 (0.5%) The following adverse reactions occurred in less than 0.5% of the 2982 adult subjects who received MultiHance: Blood and Lymphatic System Disorders: Basophilia, decreased hemoglobin, hemolysis, leukocytosis, leukopenia; Cardiac Disorders: Arrhythmia, atrial fibrillation, bradycardia, chest discomfort, ECG abnormality (bundle branch block, complete AV block, first-degree AV block, inverted T wave, prolonged PR interval, prolonged QT interval, shortened QT interval), myocardial ischemia, palpitations, supraventricular extrasystoles, tachycardia, ventricular arrhythmia, ventricular extrasystoles; Ear and Labyrinth Disorders: Ear pain, tinnitus; Eye Disorders: Eyelid edema, ocular hyperemia, visual disturbance; Gastrointestinal Disorders: Acute necrotizing pancreatitis, abdominal pain, constipation, diarrhea, dry mouth, dyspepsia, fecal incontinence, increased pruritus in patients with cirrhosis, vomiting; General Disorders and Administration Site Conditions: Asthenia, back pain, chest pain, chills, fever, infection, injection site extravasation, injection site inflammation, injection site pain, malaise, rigors; Immune System Disorders: Anaphylactic and anaphylactoid reactions, anaphylactic shock, hypersensitivity reactions; Investigations: Abnormal laboratory test (includes changes in CPK, creatinine, ferritin, transferrin, total iron binding capacity), bilirubinemia, hyperglycemia, hyperkalemia, hypocalcemia, hypoglycemia, hyponatremia, decreased blood albumin, increased alkaline phosphatase, increased GGT, increased LDH, increased serum iron, increased SGOT, increased SGPT; Musculoskeletal and Connective Tissue Disorders: Muscle spasms, myalgia, myositis; Nervous System Disorders: Aphasia, convulsion, hemiplegia, hypertonia, hypoesthesia, paralysis, parosmia, stupor, syncope, tremor; Renal and Urinary Disorders: Albuminuria, glycosuria, hematuria, proteinuria, urinary frequency, urinary tract infection; Respiratory, Thoracic and Mediastinal Disorders: Acute pulmonary edema, cough, dyspnea, hyperventilation, laryngospasm, nasal congestion, obstructive airway disorder, pulmonary embolus, wheezing; Skin and Subcutaneous Tissue Disorders: Facial edema, hyperhidrosis, pruritus, sweating, urticaria; Vascular Disorders: Hypotension. Pediatric In clinical trials, 217 pediatric subjects received MultiHance at a dose of 0.1 mmol/kg. A total of 112 (52%) subjects were male and the overall mean age was 8.3 years (range 4 days to 17 years). A total of 168 (77%) subjects were Caucasian, 12 (6%) Black, 12 (6%) Asian, 24 (11%), Hispanic, and 1 (<1%) in other racial groups. Adverse reactions were reported for 14 (6.5%) of the subjects. The frequency and the nature of the adverse reactions were similar to those seen in the adult patients. The most commonly reported adverse reactions were vomiting (1.4%), pyrexia (0.9%), and hyperhidrosis (0.9%). No subject died during study participation. A serious adverse reaction of worsening of vomiting was reported for one (0.5%) patient with a brain tumor (glioma) for which a causal relationship to MultiHance could not be excluded. 6.2 Post-marketing Experience The following adverse reactions have been identified during post approval use of MultiHance. 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. Anaphylactic, anaphylactoid and hypersensitivity reactions manifested with various degrees of severity up to anaphylactic shock, loss of consciousness and death. The reactions generally involved signs or symptoms of respiratory, cardiovascular, and/or mucocutaneous abnormalities. Extravasation of MultiHance may lead to injection site reactions, characterized by local pain or burning sensation, swelling, blistering, and necrosis [ see Warnings and Precautions (5.4) ].