ISOVUE 250

6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: 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 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 >1%) are pain, hot flashes, burning sensation, nausea, and warmth ( 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. 6.1 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. Adverse Reactions in Adults The safety of ISOVUE was evaluated in 2,246 adult patients receiving ISOVUE by intra-arterial or intravenous route in clinical studies. Table 4 shows the common adverse reactions (>1%). Table 4: Adverse Reactions Reported in >1% of Patients Receiving Intra-arterial or Intravenous Injection of ISOVUE in Clinical Studies Adverse Reaction ISOVUE (N=2,246) % Pain 2.8 Hot flashes 1.5 Burning sensation 1.4 Nausea 1.2 Warmth 1.1 The following adverse reactions occurred in ≤ 1% of patients receiving intra-arterial or intravenous injection of ISOVUE: Cardiovascular disorders: tachycardia, hypotension, hypertension, myocardial ischemia, circulatory collapse, S-T segment depression, bigeminy, extrasystoles, ventricular fibrillation, angina pectoris, bradycardia, transient ischemic attack, thrombophlebitis Gastrointestinal disorders: vomiting, anorexia General disorders: headache, fever, chills, excessive sweating, back spasm Nervous system disorders: vasovagal reaction, tingling in arms, grimace, faintness Renal and urinary disorders: urinary retention Respiratory: throat constriction, dyspnea, pulmonary edema Skin and subcutaneous tissues: rash, urticaria, pruritus, flushing Special senses: taste alterations, nasal congestion, visual disturbances Adverse Reactions in Pediatric Patients In a clinical trial with 76 pediatric patients undergoing angiocardiography, two adverse reactions (2.6%) were reported: worsening cyanosis and worsening peripheral perfusion. 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of ISOVUE. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure. Blood and lymphatic system disorders: thrombocytopenia Cardiovascular disorders: cardiopulmonary arrest, cardiac decompensation, arrhythmias, myocardial infarction, shock, electrocardiographic changes (e.g., increased QTc, increased R-R, increased T- wave amplitude), decreased systolic pressure, deep vein thrombosis, arterial spasms, vasodilation, chest pain, pallor Endocrine disorders: hyperthyroidism, hypothyroidism Eye disorders: lacrimation increased, conjunctivitis, eye pruritus, transient blindness, visual disturbance, photophobia Gastrointestinal disorders: retching, abdominal pain, salivary hypersecretion, salivary gland enlargement General disorders and administration site conditions: injection site pain, malaise Immune system disorders: anaphylaxis characterized by cardiovascular, respiratory, and cutaneous manifestations (e.g., chest tightness, laryngeal edema, periorbital edema, facial edema); delayed hypersensitivity reactions including generalized maculopapular rash, erythema, pruritus, localized blistering, skin peeling Musculoskeletal disorders: compartment syndrome following extravasation, muscle spasm, musculoskeletal pain, muscular weakness Nervous system disorders: coma, seizure, tremors, syncope, depressed level of consciousness or loss of consciousness, encephalopathy Psychiatric disorders: confusional state Respiratory system disorders: respiratory arrest, respiratory failure, acute respiratory distress syndrome, respiratory distress, apnea, asthma, sneezing, choking, laryngeal edema, bronchospasm, rhinitis Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP), erythema multiforme and drug reaction with eosinophilia and systemic symptoms (DRESS), skin necrosis, face edema

4 CONTRAINDICATIONS None. None ( 4 )

11 DESCRIPTION ISOVUE (iopamidol) injection is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5- lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C17H22I3N3O8, and the following structural formula: ISOVUE is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: ISOVUE 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine. ISOVUE 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine. ISOVUE 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine. ISOVUE 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine. The pH of ISOVUE has been adjusted to 6.5 to 7.5 with hydrochloric acid and/or sodium hydroxide. Physicochemical characteristics are shown in Table 5. ISOVUE is hypertonic as compared to plasma and cerebrospinal fluid (approximately 285 and 301 mOsm/kg water, respectively). Table 5: Physicochemical Characteristics of ISOVUE Concentration (mg Iodine/mL) 200 250 300 370 Osmolality @ 37°C (mOsm/kg water) 413 524 616 796 Viscosity (cP) @ 37°C 2.0 3.0 4.7 9.4 Viscosity (cP) @ 20°C 3.3 5.1 8.8 20.9 Specific Gravity @ 37°C 1.227 1.281 1.339 1.405 iopamidol-structure

2 DOSAGE AND ADMINISTRATION Individualize the volume and concentration according to the specific dosing tables accounting for factors such as age, body weight, size of the vessel, and the rate of blood flow within the vessel. ( 2.2 , 2.3 , 2.4 ) See full prescribing information for important dosage and administration information. ( 2.1 ) 2.1 Important Dosing and Administration Information ISOVUE is for intra-arterial or intravenous use only and must not be administered intrathecally [see Warnings and Precautions ( 5.1 )] . Specific concentrations of ISOVUE are recommended for each type of imaging procedure [see Dosage and Administration ( 2.2 , 2.3 , 2.4 )] . Individualize the volume, concentration, and injection rate of ISOVUE according to the specific dosing tables [see Dosage and Administration ( 2.2 , 2.3 , 2.4 )] . Consider factors such as: age, body weight, blood vessel size and blood flow rate, anticipated pathology and degree and extent of opacification required, structures or area to be examined, concomitant medical conditions, imaging equipment, and technique to be employed. Hydrate patients before and after ISOVUE administration [see Warnings and Precautions ( 5.3 )] . Use aseptic technique for all handling and administration of ISOVUE. ISOVUE 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 ISOVUE for particulate matter or discoloration before administration. Do not administer ISOVUE if particulate matter or discolorations are observed. Do not mix ISOVUE with other drugs or inject in intravenous lines containing other drugs or total nutritional admixtures. ISOVUE single-dose containers are intended for one procedure only. Discard any unused portion. 2.2 Recommended Dosage for Intra-arterial Procedures in Adults The recommended doses for intra-arterial procedures in adults are shown in Table 1. Table 1: Recommended Concentrations and Volumes of ISOVUE for Intra-arterial Procedures in Adults Imaging Procedure Concentration (mg Iodine/mL) Volume to Administer per Single Injection for Selected Injection Sites Maximum Cumulative Total Dose Cerebral Arteriography 300 8 mL to 12 mL by carotid puncture or transfemoral catheterization 90 mL Peripheral Arteriography 300 5 mL to 40 mL into the femoral artery or subclavian artery 25 mL to 50 mL into the aorta for a distal runoff 250 mL Selective Visceral Arteriography and Aortography 370 Up to 10 mL for the renal arteries25 mL to 50 mL into the aorta for a distal runoff Up to 50 mL into the larger vessels such as the aorta or celiac artery 225 mL Coronary Arteriography and Cardiac Ventriculography 370 2 mL to 10 mL for selective coronary artery injection 25 mL to 50 mL for cardiac ventriculography or for nonselective opacification of multiple coronary arteries following injection at the aortic root 200 mL 2.3 Recommended Dosage for Intravenous Procedures in Adults The recommended doses for intra-arterial procedures in adults are shown in Table 2. Table 2: Recommended Concentrations and Volumes of ISOVUE for Intravenous Procedures in Adults Imaging Procedure Concentration (mg Iodine/mL) Volume to Administer Excretory Urography 250 50 mL to 100 mL by rapid injection 300 50 mL by rapid injection 370 40 mL by rapid injection CT of the Head 250 130 mL to 240 mL 300 100 mL to 200 mL CT of the Body 250 130 mL to 240 mL by rapid infusion or bolus injection 300 100 mL to 200 mL by rapid infusion or bolus injection 370 80 mL to 160 mL by rapid infusion or bolus injection Peripheral Venography 200 25 mL to 150 mL per lower extremity; the maximum total dose is 350 mL 2.4 Recommended Dosage in Pediatric Patients The recommended doses in pediatric patients are shown in Table 3. Table 3: Recommended Concentrations and Volumes per Body Weight of ISOVUE for Intra- arterial and Intravenous Procedures in Pediatric Patients Imaging Procedure Concentration (mg Iodine/mL) Volume per Body Weight to Administer Maximum Dose Intra-arterial Procedures Angiocardiography 370 0.5 mL/kg to 2 mL/kg per single injection Maximum Cumulative Dose by Weight Neonates: 5 mL/kg Aged 4 weeks and older: 8 mL/kg Do not exceed maximum cumulative doses by age below. Maximum Cumulative Dose by Age <2 years 40 mL 2 years to 4 years 50 mL 5 years to 9 years 100 mL 10 years to 18 years 125 mL Intravenous Procedures Excretory Urography 250 1.2 mL/kg to 3.6 mL/kg 120 mL 300 1 mL/kg to 3 mL/kg 100 mL CT of the Head and Body 250 1.2 mL/kg to 3.6 mL/kg 120 mL 300 1 mL/kg to 3 mL/kg 100 mL

1 INDICATIONS AND USAGE ISOVUE is a radiographic contrast agent indicated for: Intra-arterial Procedures † ( 1.1 ) Cerebral arteriography in adults Peripheral arteriography in adultas Selective visceral arteriography and aortography in adults Coronary arteriography and ventriculography in adults Angiocardiography in adults and pediatric patients Intravenous Procedures † ( 1.2 ) Excretory urography and CT of the head and body in adults and pediatric patients Computed tomography (CT) of head and body in adults and pediatric patients Peripheral venography in adults † Specific concentrations are recommended for each type of imaging procedure. ( 2.2 , 2.3 , 2.4 ) 1.1 Intra-arterial Procedures † ISOVUE is indicated for: Cerebral arteriography in adults Peripheral arteriography in adults Selective visceral arteriography and aortography in adults Coronary arteriography and cardiac ventriculography in adults Angiocardiography in pediatric patients 1.2 Intravenous Procedures † ISOVUE is indicated for: Excretory urography in adults and pediatric patients Computerized tomography (CT) of the head and body in adults and pediatric patients Peripheral venography in adults † Specific concentrations of ISOVUE are recommended for each type of imaging procedure [see Dosage and Administration ( 2.2 , 2.3 , 2.4 )].

10 OVERDOSAGE The manifestations of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular systems. Treatment of an overdose is directed toward support of all vital functions and the prompt institution of symptomatic therapy. Iopamidol can be removed by dialysis.

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Intravascular injection of iopamidol opacifies those vessels where the contrast agent is present, permitting radiographic visualization through attenuation of photons. In imaging of the body, iodinated contrast agents diffuse from the vascular into the extravascular space. In normal brain with an intact blood-brain barrier, contrast does not diffuse into the extravascular space. In patients with a disrupted blood-brain barrier, contrast agent accumulates in the interstitial space in the region of disruption. 12.2 Pharmacodynamics Following administration of ISOVUE, the degree of enhancement is related to the iodine concentration in the tissue of interest. However, the exposure-response relationships and time course of pharmacodynamic response of iopamidol have not been fully characterized. 12.3 Pharmacokinetics Distribution Plasma concentrations of iodine fall within 5 to 10 minutes due to distribution into the vascular and extracellular fluid compartments. Equilibration with the extracellular compartments is reached in about 10 minutes. The apparent volume of distribution suggests that iopamidol is distributed evenly between blood and extracellular fluid. Iopamidol may be visualized in the renal parenchyma within 30 to 60 seconds following rapid intravenous administration. Iopamidol displays little tendency to bind to serum or plasma proteins. Elimination The plasma half-life is approximately 2 hours; the half-life is not dose dependent. Metabolism Iopamidol does not undergo significant metabolism, deiodination, or biotransformation. Excretion Iopamidol is excreted primarily through the kidneys. In patients with normal renal function, the cumulative urinary excretion for iopamidol, expressed as a percentage of administered intravenous dose, is approximately 35% to 40% at 60 minutes, 80% to 90% at 8 hours, and 90% or greater in the 72- to 96- hour period after administration. In patients with normal renal function, approximately 1% or less of the administered dose appears in cumulative 72- to 96-hour fecal samples.

20241219

18

3 DOSAGE FORMS AND STRENGTHS Injection: Clear, colorless to pale yellow solution available in the following concentrations of iodine: Concentration (mg Iodine/mL) Package Size Package Type 200 200 mL Single-Dose Bottle 250 100 mL Single-Dose Bottle 300 30 mL and 50 mL Single-Dose Vial 100 mL and 150 mL Single-Dose Bottle 370 50 mL Single-Dose Vial 75 mL, 100 mL, 125 mL, and 150 mL Single-Dose Bottle Injection: 200 mg Iodine/mL, 250 mg Iodine/mL, 300 mg Iodine/mL, and 370 mg Iodine/mL in single-dose vials or bottles( 3 )

ISOVUE 300 IOPAMIDOL IOPAMIDOL IOPAMIDOL TROMETHAMINE EDETATE CALCIUM DISODIUM ISOVUE 370 IOPAMIDOL IOPAMIDOL IOPAMIDOL TROMETHAMINE EDETATE CALCIUM DISODIUM ISOVUE 200 IOPAMIDOL IOPAMIDOL IOPAMIDOL TROMETHAMINE EDETATE CALCIUM DISODIUM ISOVUE 250 IOPAMIDOL IOPAMIDOL IOPAMIDOL TROMETHAMINE EDETATE CALCIUM DISODIUM

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed with iopamidol to evaluate carcinogenic potential. No evidence of genetic toxicity was obtained in in vitro tests. In animal reproduction studies performed on rats, intravenously administered iopamidol did not induce adverse effects on fertility or general reproductive performance.

NDA018735

ISOVUE 250

IOPAMIDOL

0270-1317

HUMAN PRESCRIPTION DRUG

INTRAVASCULAR

Isovue 200: 200mL vial label NDC 0270-1314-15 Isovue-200 Bottle 200 ml

17 PATIENT COUNSELING INFORMATION Hypersensitivity Reactions Advise the patient concerning the risk of hypersensitivity reactions that can occur both during and after ISOVUE administration. Advise the patient to report any signs or symptoms of hypersensitivity reactions during the procedure and to seek immediate medical attention for any signs or symptoms experienced after discharge [see Warnings and Precautions ( 5.2 )]. Advise patients to inform their physician if they develop a rash after receiving ISOVUE [see Warnings and Precautions ( 5.11 )]. Acute Kidney Injury Advise the patient concerning appropriate hydration to decrease the risk of contrast induced kidney injury [see Warnings and Precautions ( 5.3 )]. Extravasation If extravasation occurs during injection, advise patients to seek medical care for progression of symptoms [see Warnings and Precautions ( 5.6 )]. Thyroid Dysfunction Advise parents/caregivers about the risk of developing thyroid dysfunction after ISOVUE administration. Advise parents/caregivers about when to seek medical care for their child to monitor for thyroid function [see Warnings and Precautions ( 5.8 )]. Lactation Advise a lactating woman that interruption of breastfeeding is not necessary, however, to minimize exposure to a breastfed infant, a lactating woman may consider pumping and discarding breast milk for 10 hours after ISOVUE administration [see Use in Specific Populations ( 8.2 )]. Manufactured for: Bracco Diagnostic Inc. Monroe Township, NJ 08831 Manufactured by: BIPSO GmbH 78224 Singen (Germany) ISOVUE is a registered trademark of Bracco Diagnostics Inc. Revised December 2024

7 DRUG INTERACTIONS 7.1 Drug-Drug Interactions Metformin In patients with renal impairment, metformin can cause lactic acidosis. Iodinated contrast agents appear to increase the risk of metformin-induced lactic acidosis, possibly as a result of worsening renal function. Stop metformin at the time of, or prior to, ISOVUE administration in patients with an eGFR between 30 and 60 mL/min/1.73 m 2 ; in patients with a history of hepatic impairment, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast agents. Re-evaluate eGFR 48 hours after the imaging procedure and reinstitute metformin use only after renal function is stable. Radioactive Iodine Administration of ISOVUE may interfere with thyroid uptake of radioactive iodine (I-131 and I-123) and decrease therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post ISOVUE. 7.2 Drug-Laboratory Test Interactions Protein-Bound Iodine Test Iodinated contrast agents, including ISOVUE, will temporarily increase protein-bound iodine in blood. Avoid protein-bound iodine test for at least 16 days following administration of ISOVUE. However, thyroid function tests that do not depend on iodine estimations, e.g., triiodothyronine (T 3 ) resin uptake and total or free thyroxine (T 4 ) assays are not affected.

8.1 Pregnancy Risk Summary Available data from published literature and postmarketing cases from decades of use with iopamidol during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Iopamidol crosses the placenta and reaches fetal tissues in small amounts ( see Data ). In animal reproduction studies, no adverse developmental outcomes were observed with intravenous administration of iopamidol to pregnant rats and rabbits during organogenesis at doses up to 2.7 and 1.4 times, respectively, the maximum recommended human dose ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Literature reports show that intravenously administered iopamidol crosses the placenta and is visualized in the digestive tract of exposed infants after birth. Animal Data Iopamidol did not affect fetal development and did not induce teratogenic changes in the offspring in either rats or rabbits at the following dose levels tested: 600 mg, 1,500 mg, or 4,000 mg iodine/kg in rats, administered intravenously once a day during days 6 through 15 of pregnancy; 300 mg, 800 mg, or 2,000 mg iodine/kg in rabbits, administered intravenously once a day during days 6 through 18 of pregnancy.

8 USE IN SPECIFIC POPULATIONS Lactation: A lactating woman may pump and discard breast milk for 10 hours after ISOVUE administration. ( 8.2) 8.1 Pregnancy Risk Summary Available data from published literature and postmarketing cases from decades of use with iopamidol during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Iopamidol crosses the placenta and reaches fetal tissues in small amounts ( see Data ). In animal reproduction studies, no adverse developmental outcomes were observed with intravenous administration of iopamidol to pregnant rats and rabbits during organogenesis at doses up to 2.7 and 1.4 times, respectively, the maximum recommended human dose ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Literature reports show that intravenously administered iopamidol crosses the placenta and is visualized in the digestive tract of exposed infants after birth. Animal Data Iopamidol did not affect fetal development and did not induce teratogenic changes in the offspring in either rats or rabbits at the following dose levels tested: 600 mg, 1,500 mg, or 4,000 mg iodine/kg in rats, administered intravenously once a day during days 6 through 15 of pregnancy; 300 mg, 800 mg, or 2,000 mg iodine/kg in rabbits, administered intravenously once a day during days 6 through 18 of pregnancy. 8.2 Lactation Risk Summary There are no data on the presence of iopamidol in human milk, the effects on the breastfed infant, or the effects on milk production. Iodinated contrast agents are present unchanged in human milk in very low amounts, with poor absorption from the gastrointestinal tract of a breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ISOVUE and any potential adverse effects on the breastfed infant from ISOVUE or from the underlying maternal condition. Clinical Considerations Interruption of breastfeeding after exposure to iodinated contrast agents is not necessary because the potential exposure of the breastfed infant to iodine is small. However, a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 10 hours (approximately 5 half- lives) after ISOVUE administration in order to minimize drug exposure to a breastfed infant. 8.4 Pediatric Use The safety and effectiveness of ISOVUE have been established in pediatric patients for angiocardiography, excretory urography, and contrast computed tomography (head and body). Pediatric patients at higher risk of experiencing adverse reactions during and after contrast medium administration may include those having asthma, sensitivity to medication or allergens, cyanotic heart disease, congestive heart failure, or serum creatinine greater than 1.5 mg/dL, or those less than 12 months of age. Thyroid function tests indicative of thyroid dysfunction, characterized by hypothyroidism or transient thyroid suppression have been reported following iodinated contrast media administration in pediatric patients, including term and preterm neonates; some patients were treated for hypothyroidism. After exposure to iodinated contrast media, individualize thyroid function monitoring in pediatric patients 0 years to 3 years of age based on underlying risk factors, especially in term and preterm neonates [see Warning and Precautions ( 5.8 ) and Adverse Reactions ( 6.2 )]. The safety and effectiveness of ISOVUE for cerebral, peripheral, and selective visceral arteriography, aortography, coronary arteriography, cardiac ventriculography, and peripheral venography have not been established in pediatric patients. 8.5 Geriatric Use Iopamidol is excreted by the kidney, and the risk of adverse reactions to ISOVUE may be greater in patients with renal impairment. Because patients 65 years of age and older are more likely to have renal impairment, care should be taken in dose selection, and it may be useful to monitor renal function [see Warnings and Precautions ( 5.3 ) and Use in Specific Populations [ 8.6 ]). 8.6 Renal Impairment The clearance of iopamidol decreases with increasing degree of renal impairment and results in delayed opacification of the urinary system. In addition, preexisting renal impairment increases the risk for acute kidney injury [see Warnings and Precautions ( 5.3 )] . Iopamidol can be removed by dialysis.

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ISOVUE (iopamidol) injection is a clear, colorless to pale yellow solution available in the following presentations: Concentration (mg Iodine/mL) Package Size Package Type Sale Unit NDC 200 200 mL Single-Dose Bottle Carton of 10 0270-1314-15 250 100 mL Single-Dose Bottle Carton of 10 0270-1317-02 300 30 mL Single-Dose Vial Carton of 10 0270-1315-25 50 mL Single-Dose Vial Carton of 10 0270-1315-30 100 mL Single-Dose Bottle Carton of 10 0270-1315-35 150 mL Single-Dose Bottle Carton of 10 0270-1315-50 370 50 mL Single-Dose Vial Carton of 10 0270-1316-30 75 mL Single-Dose Bottle Carton of 10 0270-1316-52 100 mL Single-Dose Bottle Carton of 10 0270-1316-35 125 mL Single-Dose Bottle Carton of 10 0270-1316-04 150 mL Single-Dose Bottle Carton of 10 0270-1316-37 Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature]. Protect from light.

WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION Intrathecal administration, even if inadvertent, can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema [see Warnings and Precautions ( 5.1 )]. ISOVUE is for intra-arterial or intravenous use only [see Dosage and Administration ( 2.1 )]. . WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION Intrathecal administration, even if inadvertent, can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. ISOVUE is for intra-arterial or intravenous use only. ( 5.1 )