FDA label 1fc00d4f-df26-1fb8-e063-6294a90aaee2

WARNING: RISKS WITH INADVERTENT INTRATHECAL ADMINISTRATION FOR INTRAVENOUS USE ONLY. Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema [see Warnings and Precautions (5.1) ] . WARNING: RISKS WITH INADVERTANT INTRATHECAL ADMINISTRATION See full prescribing information for complete boxed warning. FOR INTRAVENOUS USE ONLY. Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema ( 5.1 ) .

5 WARNINGS AND PRECAUTIONS For intravenous use only. ( 5.1 ) Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency equipment and trained personnel available. ( 5.2 ) Contrast Induced Acute Kidney Injury: Acute injury including renal failure can occur. Minimize dose and maintain adequate hydration to minimize risk. ( 5.3 ) Cardiovascular Adverse Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after administration. ( 5.4 ) Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age: Monitor these patients for thyroid function abnormalities and treat as clinically needed. ( 5.7 ) 5.1 Risks with Inadvertent Intrathecal Administration OMNIPAQUE is for intravenous use only [see Dosage and Administration (2.1) ]. Inadvertent Intrathecal administration can cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema. 5.2 Hypersensitivity Reactions OMNIPAQUE, can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock. Most severe reactions develop shortly after the start of the injection (within 3 minutes), but reactions can occur up to hours later. There is an increased risk in patients with a history of a previous reaction to contrast agent, and known allergies (i.e., bronchial asthma, drug, or food allergies) or other hypersensitivities. Premedication with antihistamines or corticosteroids does not prevent serious life-threatening reactions, but may reduce both their incidence and severity. Obtain a history of allergy, hypersensitivity, or hypersensitivity reactions to iodinated contrast agents and always have emergency resuscitation equipment and trained personnel available prior to OMNIPAQUE administration. Monitor all patients for hypersensitivity reactions. 5.3 Contrast-Induced Acute Kidney Injury Acute kidney injury, including renal failure, may occur after OMNIPAQUE administration. Risk factors include: pre-existing renal impairment, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, elderly age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma/paraproteinaceous diseases, repetitive and/or large doses of an iodinated contrast agent. Use the lowest necessary dose of OMNIPAQUE in patients with renal impairment. Adequately hydrate patients prior to and following OMNIPAQUE administration. Do not use laxatives, diuretics, or preparatory dehydration prior to OMNIPAQUE administration. 5.4 Cardiovascular Adverse Reactions Life-threatening or fatal cardiovascular reactions including hypotension, shock, cardiac arrest have occurred with the use of OMNIPAQUE. Based upon clinical literature, reported deaths from the administration of iodinated contrast agents range from 6.6 per million (0.00066%) to 1 per 10,000 (0.01%). Most deaths occur during injection or 5 to 10 minutes later; the main feature being cardiac arrest with cardiovascular disease as the main aggravating factor. OMNIPAQUE has the potential to transiently increase in the circulatory osmotic load in patients with congestive heart failure. Use the lowest necessary dose of OMNIPAQUE in patients with congestive heart failure and observe these patients for several hours following the procedure to detect delayed hemodynamic disturbances. Monitor all patients for severe cardiovascular reactions always have emergency resuscitation equipment and trained personnel available. 5.5 Extravasation and Injection Site Reactions Extravasation of intravenously administered OMNIPAQUE may cause tissue necrosis and/or compartment syndrome, particularly in patients with severe arterial or venous disease. Ensure intravenous placement of catheters prior to injection. Monitor patients for extravasation and advise patients to seek medical care for progression of symptoms. 5.6 Thyroid Storm in Patients with Hyperthyroidism Thyroid storm has occurred after the intravascular use of iodinated contrast agents in patients with hyperthyroidism, or with an autonomously functioning thyroid nodule. Evaluate the risk in such patients before use of OMNIPAQUE. 5.7 Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age Thyroid dysfunction characterized by hypothyroidism or transient thyroid suppression has been reported after both single exposure and multiple exposures to iodinated contrast media in pediatric patients 0 to 3 years of age. ​ Younger age, very low birth weight, prematurity, underlying medical conditions affecting thyroid function, admission to neonatal or pediatric intensive care units, and congenital cardiac conditions are associated with an increased risk of hypothyroidism after ICM exposure. Pediatric patients with congenital cardiac conditions may be at the greatest risk given that they often require high doses of contrast during invasive cardiac procedures. An underactive thyroid during early life may be harmful for cognitive and neurological development and may require thyroid hormone replacement therapy. After exposure to iodinated contrast media, individualize thyroid function monitoring based on underlying risk factors, especially in term and preterm neonates. 5.8 Hypertensive Crisis in Patients with Pheochromocytoma Hypertensive crisis has occurred after the use of iodinated contrast agents in patients with pheochromocytoma. Monitor patients when administering OMNIPAQUE if pheochromocytoma or catecholamine-secreting paragangliomas are suspected. Inject the minimum amount of contrast necessary, assess the blood pressure throughout the procedure, and have measures for treatment of a hypertensive crisis readily available. 5.9 Sickle Cell Crisis in Patients with Sickle Cell Disease Iodinated contrast agents when administered intravascularly may promote sickling in individuals who are homozygous for sickle cell disease. Hydrate patients prior to and following OMNIPAQUE administration and use OMNIPAQUE only if the necessary imaging information cannot be obtained with alternative imaging modalities. 5.10 Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravascular contrast agent administration. These reactions include Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS). Reaction severity may increase and time to onset may decrease with repeat administration of contrast agents; prophylactic medications may not prevent or mitigate severe cutaneous adverse reactions. Avoid administering OMNIPAQUE to patients with a history of a severe cutaneous adverse reaction to OMNIPAQUE.

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Risks Associated with Inadvertent Intrathecal Administration [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Contrast-Induced Kidney Injury [see Warnings and Precautions (5.3) ] Cardiovascular Adverse Reactions [see Warnings and Precautions (5.4) ] Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age [see Warnings and Precautions 5.7 ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.10) ] Most common adverse reactions in adult patients:(incidence ≥ 1%) pain, vision abnormalities (including blurred vision and photomas), headache, taste perversion, arrhythmias including premature ventricular contractions (PVCs) and premature atrial contractions (PACs), angina/chest pain, nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 1-800-654-0118 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. Adults : The following Adverse Reactions are listed in decreasing frequency within each subgroup. Cardiovascular System: arrhythmias including premature ventricular contractions (PVCs) and premature atrial contractions (PACs), angina/chest pain, hypotension, cardiac failure, asystole, bradycardia, tachycardia, and vasovagal reaction Nervous System: pain, vision abnormalities (including blurred vision and photomas), headache, taste perversion, vertigo, dizziness, lightheadedness, anxiety, fever, motor and speech dysfunction, convulsion, paresthesia, somnolence, stiff neck, hemiparesis, syncope, shivering, transient ischemic attack, cerebral infarction, and nystagmus. Respiratory System: dyspnea, rhinitis, coughing, and laryngitis Gastrointestinal System: nausea, vomiting, diarrhea, dyspepsia, cramp, and dry mouth Skin and Appendages: urticaria, purpura, abscess, and pruritus Pediatric Patients: In controlled clinical trials involving pediatric patients for CT head imaging, adverse reactions following the use of OMNIPAQUE (300 mg iodine/mL) were similar in quality and frequency to those seen with adults. 6.2 Post-Marketing Experience The following additional reactions have been identified during post-approval intravascular use of OMNIPAQUE. 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 exposure. Hemodynamic Reactions: vein cramp and thrombophlebitis following intravenous injection Blood and Lymphatic System Disorders: neutropenia Cardiovascular Disorders: cardiac arrest, shock, peripheral vasodilatation hypertension, myocardial infarction, spasm of coronary arteries, reflex tachycardia, cyanosis, pallor, flushing Eye Disorders: transient visual impairment including cortical blindness, eyelid edema, conjunctival symptoms, lacrimation Endocrine Reactions: hyperthyroidism, hypothyroidism Gastrointestinal Disorders: abdominal pain, pancreatitis aggravated, salivary gland enlargement General Disorders and Administration Site Conditions: chills, pyrexia, pain and discomfort, weakness, administration site conditions including extravasation, feeling hot Immune System Disorders: hypersensitivity reactions, anaphylactic or anaphylactoid shock including life-threatening or fatal anaphylaxis Musculoskeletal and Connective Tissue Disorders: back pain Nervous System Disorders: coma, disturbance in consciousness, transient contrast-induced encephalopathy caused by extravasation of contrast media (including amnesia, hallucination, paralysis, paresis, speech disorder, aphasia, dysarthria), restlessness, tremors, hypoesthesia Psychiatric Disorders: confusional state, agitation Renal Disorders: acute kidney injury, nephropathy toxic, transient proteinuria, oliguria or anuria, increased serum creatinine Respiratory; Thoracic, and Mediastinal Disorders: respiratory arrest, pulmonary or laryngeal edema, bronchospasm, sneezing, throat irritation, throat tightness, laryngeal edema, pharyngeal edema, asthmatic attack Skin and Subcutaneous Tissue Disorders: Reactions range from mild (e.g. pleomorphic rashes, drug eruption, erythema, pruritus, urticaria and skin discoloration, hyperhidrosis, angioedema, localized areas of edema) to severe: [e.g., Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS)]