The following clinically significant adverse reactions are described elsewhere in the labeling: Risks Associated with Intrathecal Administration [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] Acute Kidney Injury [see Warnings and Precautions ( 5.3 )] Cardiovascular Adverse Reactions [see Warnings and Precautions ( 5.4 )] Thromboembolic Events [see Warnings and Precautions ( 5.5 )] Extravasation and Injection Site Reactions [see Warnings and Precautions ( 5.6 )] Thyroid Dysfunction in Pediatric Patients 0 Years to 3 Years of Age [see Warnings and Precautions ( 5.8 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.11 )] Most common adverse reactions (incidence ≥0.5%) are feeling hot, headache, nausea, chest pain, back pain, and vomiting.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc. at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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. Adverse Reactions in Adult Patients The safety of IOMERVU was evaluated in 4,621 adult patients who received 1,500 mg to 86,000 mg iodine doses of IOMERVU intra-arterially or intravenously in clinical trials.
The average age was 60 years (range 18 years to 99 years), and 34% were female. The racial and ethnic distribution was 83% White, 10% Asian, 1% Black, 1% Hispanic, and 5% patients of other or unspecified groups. Table 5 provides a summary of the adverse reactions reported in ≥0.5% of adult patients. Table 5: Adverse Reactions Reported in ≥0.5% of 4,621 Adult Patients Receiving Intra-arterial or Intravenous Administration of IOMERVU in Clinical Trials Adverse Reaction Incidence (%) Feeling hot 2 Headache
0.5 The following adverse reactions were observed in <0.5% of the adult patients receiving IOMERVU: Blood and lymphatic system disorders: activated partial thromboplastin time prolonged, prothrombin time prolonged Cardiovascular disorders: ventricular fibrillation, hypertensive crisis, coronary arteriospasm, congestive cardiac failure, cardiac flutter, atrioventricular block, right bundle branch block, hypotension, arrhythmia, bradycardia, supraventricular extrasystoles, ventricular extrasystoles, increased blood pressure, flushing Ear and labyrinth disorders : vertigo, ear discomfort Eye disorder: vision blurred, periorbital edema, photopsia Gastrointestinal : esophageal varices hemorrhage, abdominal pain, abdominal distension, alanine aminotransferase (ALT) increased, constipation, diarrhea, dry mouth, salivary hypersecretion, oral paresthesia General disorders: pain, injection site reactions (pain, discomfort, or warmth), peripheral edema, chills, asthenia, malaise Musculoskeletal and connective tissue disorders: arthralgia, pain in jaw Nervous system disorders: cerebrovascular disorder, dysarthria, visual field defect, burning sensation, presyncope, dizziness, dysgeusia, paresthesia Psychiatric disorders : delirium, anxiety, insomnia Renal and urinary disorders: acute kidney injury, increased blood creatinine, urinary urgency Respiratory, thoracic, and mediastinal disorders: respiratory arrest, pulmonary edema, bronchospasm, dyspnea, cough, rhinitis, throat irritation or tightness, sneezing Skin and subcutaneous tissue disorders: urticaria, blister, purpura, ecchymosis, rash, pruritus, erythema Adverse Reactions in Pediatric Patients The safety of IOMERVU was evaluated in 184 pediatric patients who received 1,800 mg to 76,000 mg iodine doses of IOMERVU intra-arterially or intravenously in clinical trials.
The average age was 6 years (range 11 days to 17 years), and 47% were female. The racial distribution was 98% White, 1% Black, and 1% patients of other or unspecified groups. The overall character, quality, and severity of adverse reactions reported in pediatric patients were similar to those reported in adult patients.
6.2Post Marketing Experience
The following adverse reactions have been identified during post-approval use of IOMERVU outside the United States. 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. Blood and lymphatic system disorders: thrombocytopenia, leukopenia, leukocytosis Cardiovascular disorders: cardio-respiratory arrest, circulatory collapse or shock, myocardial infarction, atrial fibrillation, cyanosis, pallor Endocrine disorders: hyperthyroidism, hypothyroidism Eye disorders: transient blindness, conjunctivitis, increased lacrimation Gastrointestinal disorders: salivary gland enlargement, increased aspartate aminotransferase (AST), dysphagia General disorders and administration site conditions: injection site swelling (usually due to extravasation) Immune system disorders: hypersensitivity reactions including fatal anaphylaxis Nervous system disorders: coma, loss of consciousness, encephalopathy, transient ischemic attack, paralysis, convulsion, syncope, amnesia, somnolence Psychiatric disorders : confusional state Respiratory, thoracic, and mediastinal disorders: acute respiratory distress syndrome (ARDS), laryngeal edema, pharyngeal edema, dysphonia Skin and subcutaneous tissue disorders : severe reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS)) and mild reactions (rash, erythema, pruritus, urticaria, and skin discoloration)
