IOMERVU

2 DOSAGE AND ADMINISTRATION Individualize the volume and concentration according to the specific dosing tables accounting for factors such as age, body weight, vessel size, rate of blood flow within the vessel, and structures or areas to be examined. ( 2.2 , 2.3 , 2.4 , 2.5 ) See full prescribing information for complete dosage and administration information. ( 2 ) 2.1 Important Dosing and Administration Information IOMERVU is for intra-arterial or intravenous use only and must not be administered intrathecally [see Warnings and Precautions ( 5.1 )] . Specific concentrations of IOMERVU are recommended for each type of imaging procedure [see Dosage and Administration ( 2.2 , 2.3 , 2.4 , 2.5 )]. Individualize the volume, concentration, and injection rate of IOMERVU within the specified ranges [see Dosage and Administration ( 2.2 , 2.3 , 2.4 , 2.5 )]. Consider factors such as age, body weight, vessel size, rate of blood flow within the vessel, anticipated pathology, degree and extent of opacification required, structures or area to be examined, disease processes affecting the patient, and equipment and technique to be employed. Hydrate patients before and after IOMERVU administration [see Warnings and Precautions ( 5.3 )] . Use aseptic technique for all handling and administration of IOMERVU. IOMERVU may be administered at either body temperature (37°C, 98.6°F) or room temperature (20°C to 25°C, 68°F to 77°F). Visually inspect IOMERVU for particulate matter or discoloration before administration, whenever the solution and container permit. Do not administer IOMERVU if particulate matter or discoloration is observed. Do not mix IOMERVU with, or inject in intravenous lines containing, other drugs or total nutritional admixtures. Each single-dose container of IOMERVU injection is intended for one procedure only. Discard any unused portion. 2.2 Recommended Dosage for Intra-arterial Procedures in Adults Recommended doses of IOMERVU in adults for intra-arterial procedures are shown in Table 1. Inject at rates approximately equal to the flow rate in the vessel being injected. Table 1. Recommended Concentrations and Volumes of IOMERVU to Administer per Single Injection into Selected Arteries for Intra-arterial Procedures in Adults Imaging Procedure Concentration (mg Iodine/mL) Volume (mL) Maximum Total Dose (mL) Cerebral arteriography 300 Carotid, subclavian, and vertebral arteries: 6 mL to 12 mL Aortic arch: 30 mL to 50 mL 200 mL Visceral and peripheral arteriography; aortography 300 Aortography: 30 mL to 70 mL Renal arteries: 10 mL to 12 mL Other major branches of aorta: 20 mL to 60 mL 200 mL Intra-arterial digital subtraction angiography 300 Carotid, subclavian, and vertebral arteries: 4 mL to 12 mL Aortic arch: 20 mL to 25 mL Aortography: 15 mL to 40 mL Renal arteries: 6 mL to 16 mL Other major branches of aorta: 10 mL to 40 mL Ilio-femoral runoff: 8 mL to 40 mL 200 mL Coronary arteriography and cardiac ventriculography 300 Coronary arteries: 3 mL to 7 mL Cardiac ventriculography: 30 mL to 45 mL 286 mL 350 245 mL 400 215 mL 2.3 Recommended Dosage for Intra-arterial Procedures in Pediatric Patients Recommended doses of IOMERVU in pediatric patients for intra-arterial procedures are shown in Table 2. Inject at rates approximately equal to the flow rate in the vessel being injected. Table 2. Recommended Concentrations and Volumes per Body Weight of IOMERVU to Administer per Single Injection for Intra-arterial Procedures in Pediatric Patients Imaging Procedure Concentration (mg Iodine/mL) Volume (mL/kg body weight) Maximum Total Dose (mL/kg) Cerebral arteriography 300 0.5 mL/kg to 2 mL/kg 5 mL/kg Do not exceed adult maximum dose (see Table 1) Visceral and peripheral arteriography; aortography 300 0.5 mL/kg to 2 mL/kg Intra-arterial digital subtraction angiography 300 0.3 mL/kg to 1 mL/kg Radiographic evaluation of cardiac chambers and related arteries 300, 350, or 400 0.5 mL/kg to 2 mL/kg 2.4 Recommended Dosage for Intravenous Procedures in Adults Recommended doses of IOMERVU in adults for intravenous procedures are shown in Table 3. Table 3. Recommended Concentrations, Volumes, and Injection Rates of IOMERVU for Intravenous Procedures in Adults Imaging Procedure Concentration (mg Iodine/mL) Volume (mL) Injection Rate 3 (mL/s) CT of Head and Body 250 or 300 100 mL to 190 mL 2 mL/s to 4 mL/s 350 or 400 75 mL to 150 mL CT Angiography 1 300, 350, or 400 80 mL to 130 mL 4 mL/s to 6 mL/s Coronary CT Angiography 1 400 50 mL to 90 mL 4 mL/s to 6 mL/s CT Urography 2 350 90 mL to 120 mL 2.5 mL/s 1 The IOMERVU volume may be immediately followed by a 40 mL to 50 mL 0.9% sodium chloride injection flush at the same flow rate as the contrast volume. 2 The IOMERVU volume may be administered either as a single bolus, or for dual-phase protocols as divided doses. 3 The injection rate of IOMERVU should be determined according to the clinical indication and the location, size, and type of the intravenous access. 2.5 Recommended Dosage for Intravenous Procedures in Pediatric Patients Recommended doses of IOMERVU in pediatric patients for intravenous procedures are shown in Table 4. Table 4. Recommended Concentrations, Volumes per Body Weight, and Injection Rates of IOMERVU for Intravenous Procedures in Pediatric Patients Imaging Procedure Concentration (mg Iodine/mL) Volume (mL/kg body weight) Injection Rate (mL/s)* CT of Head and Body 250 or 300 1.5 mL/kg to 2.5 mL/kg 1 mL/s to 2 mL/s 350 or 400 1 mL/kg to 2 mL/kg CT Angiography 300, 350, or 400 1 mL/kg to 2 mL/kg 2 mL/s to 3 mL/s Coronary CT Angiography 300 or 400 1 mL/kg to 2 mL/kg 2 mL/s to 3 mL/s CT Urography 300 1 mL/kg to 2 mL/kg 1 mL/s to 2 mL/s * The injection rate of IOMERVU should be determined according to the clinical indication and the location, size, and type of the intravenous access. In neonates and patients <15 kg in whom a 24-gauge angiocatheter is the only option, an injection rate of 1 mL/s is recommended.

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1 INDICATIONS AND USAGE IOMERVU is a radiographic contrast agent indicated for: Intra-arterial Procedures † ( 1.1 ) Cerebral arteriography, includingintra-arterial digital subtraction angiography (IA-DSA), in adults and pediatric patients Visceral and peripheral arteriography and aortography, including IA-DSA, in adults and pediatric patients Coronary arteriography and cardiac ventriculography in adults Radiographic evaluation of cardiac chambers and related arteries in pediatric patients Intravenous Procedures † ( 1.2 ) Computed tomography (CT) of the head and body in adults and pediatric patients CT angiography of intracranial, visceral, and lower extremity arteries in adults and pediatric patients Coronary CT angiography in adults and pediatric patients CT urography in adults and pediatric patients † Specific concentrations are recommended for each type of imaging procedure.