Iomeprol
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION Intrathecal administration, even if inadvertent, may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. IOMERVU is for intra-arterial or intravenous use only [see Dosage and Administration ( 2.1 ) and Warnings and Precautions ( 5.1 )]. WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION Intrathecal administration, even if inadvertent, may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.
IOMERVU is for intra-arterial or intravenous use only. (2.1, 5.1)
Radiographic Contrast Agent
Dosing in kidney impairment
Renal Impairment Preexisting renal impairment increases the risk for acute kidney injury . Renal impairment reduces the rate of elimination of iomeprol . Iomeprol can be removed by dialysis [see Warnings and Precautions and Clinical Pharmacology].
| 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 mLAortic 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 mLOther 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 mLAortic arch: 20 mL to 25 mLAortography: 15 mL to 40 mLRenal arteries: 6 mL to 16 mLOther major branches of aorta: 10 mL to 40 mLIlio-femoral runoff: 8 mL to 40 mL | 200 mL |
| Coronary arteriography and cardiac ventriculography | 300 | Coronary arteries: 3 mL to 7 mLCardiac ventriculography: 30 mL to 45 mL | 286 mL |
| 350 | 245 mL | ||
| 400 | 215 mL | ||
Preparation and administration
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Important Dosing and Administration Information IOMERVU is for intra-arterial or intravenous use only and must not be administered intrathecally [see Warnings and Precautions] . 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] . 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.
| 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 mLAortic 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 mLOther 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 mLAortic arch: 20 mL to 25 mLAortography: 15 mL to 40 mLRenal arteries: 6 mL to 16 mLOther major branches of aorta: 10 mL to 40 mLIlio-femoral runoff: 8 mL to 40 mL | 200 mL |
| Coronary arteriography and cardiac ventriculography | 300 | Coronary arteries: 3 mL to 7 mLCardiac ventriculography: 30 mL to 45 mL | 286 mL |
| 350 | 245 mL | ||
| 400 | 215 mL | ||
| 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/kgDo 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 | |
| Table 3. Recommended Concentrations, Volumes, and Injection Rates of IOMERVU for Intravenous Procedures in Adults | |||
| Imaging Procedure | Concentration (mg Iodine/mL) | Volume (mL) | Injection Rate3 (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 Angiography1 | 300, 350, or 400 | 80 mL to 130 mL | 4 mL/s to 6 mL/s |
| Coronary CT Angiography1 | 400 | 50 mL to 90 mL | 4 mL/s to 6 mL/s |
| CT Urography2 | 350 | 90 mL to 120 mL | 2.5 mL/s |
Drug interactions
Check iomeprol against a medication listLabel text (4 paragraphs)
7 DRUG INTERACTIONS
7.1 Drug-Drug Interactions Metformin Stop metformin at the time of, or prior to, IOMERVU 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 only after renal function is stable. Metformin can cause lactic acidosis in patients with renal impairment. Iodinated contrast agents appear to increase the risk of metformin-induced lactic acidosis, possibly as a result of worsening renal function.
Radioactive Iodine Avoid thyroid therapy or testing using radioactive iodine for up to 6 weeks post IOMERVU. Administration of IOMERVU may interfere with thyroid uptake of radioactive iodine (I-131 and I-123) and decrease therapeutic and diagnostic efficacy.
7.2 Drug-Laboratory Test Interactions Protein-Bound Iodine Test Do not perform a protein-bound iodine test for at least 16 days following administration of IOMERVU. Iodinated contrast agents, including IOMERVU, will temporarily increase protein-bound iodine in blood. 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.
Contraindications
None. None ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Available data from literature and postmarketing reports on iomeprol use in pregnant women over decades have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, no adverse developmental outcomes were observed with intravenous administration of iomeprol to pregnant rats and rabbits at doses up to 0.45-times the maximum recommended human dose of 86,000 mg iodine. Animal studies show that iomeprol crosses the placenta ( 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 defects, 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 Animal Data Embryo-fetal developmental toxicity studies were performed with intravenous administration of iomeprol in rats at daily doses of 600 mg, 1,500 mg, or 4,000 mg iodine/kg (0.07-, 0.17- or 0.45-fold the human equivalent dose (HED, mg/m 2 ) using the maximum human dose of 86,000 mg iodine per administration) from gestation days (GD) 6 to 15 and in rabbits at daily doses of 300 mg, 800 mg, or 2,000 mg iodine/kg (0.07-, 0.18- or 0.45-fold the HED using the maximum human dose of 86,000 mg iodine per administration) from GD 6 to 18. Iomeprol did not result in fetal harm at the highest doses evaluated, 0.45-times the maximum recommended human dose of 86,000 mg iodine.
A biodistribution study with a single intravenous administration of 1,000 mg iodine/kg (0.11-fold the HED using the maximum human dose of 86,000 mg iodine per administration) of radiolabeled iomeprol to pregnant rats showed that iomeprol crosses the placenta. No accumulation of radioactivity in fetal tissues was observed.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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