Iomeprol

Iomeprol is a radiographic contrast agent indicated for:

• Intra-arterial procedures
  • Cerebral arteriography, including intra-arterial digital subtraction angiography, in adults and pediatric patients
  • Visceral and peripheral arteriography and aortography, including IA-DSA, in adult and pediatric patients
  • Coronary arteriography and cardiac ventriculography in adults
  • Radiographic evaluation of cardiac chambers and related arteries in pediatric patients
• Intravenous procedures
  • 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

 Iomeprol is available under the following different brand names: Iomervu.

Common side effects of Iomeprol include:

• feeling hot
• headache 
• nausea 
• chest pain 
• back pain 
• vomiting 

Serious side effects of Iomeprol include:

• not available

Rare side effects of Iomeprol include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, solution

Iodine/mL

• 250 mg (100-mL bottle)
• 300 mg (50-mL vial; 100-, 150-, 200-mL bottles)
• 350 mg (50-mL vial; 100-, 150-, 200-mL bottles)
• 400 mg (50-mL vial; 100-, 150-, 200-mL bottles)

Radiologic imaging (intra-arterial procedures)

Adult dosage

• Inject at rates approximately equal to the flow rate of the vessel being injected
• Cerebral arteriography
  • Includes intra-arterial digital subtraction angiography (IA-DSA)
  • Concentration (iodine): 300 mg/mL
  • Carotid, subclavian, and vertebral arteries: 6-12 mL
  • Aortic arch: 30-50 mL
  • Maximum total dose: 200 mL
• Visceral and peripheral arteriography and aortography
  • Includes IA-DSA
  • Concentration (iodine): 300 mg/mL
  • Aortography: 30-70 mL
  • Renal arteries: 10-12 mL
  • Other major branches of aorta: 20-60 mL
  • Maximum total dose: 200 mL
  • IA-DSA
    • Concentration (iodine): 300 mg/mL
    • Carotid, subclavian, and vertebral arteries: 4-12 mL
    • Aortic arch: 20-25 mL
    • Aortography: 15-40 mL
    • Renal arteries: 6-16 mL
    • Other major branches of aorta: 10-40 mL
    • Ilio-femoral runoff: 8-40 mL
    • Maximum total dose: 200 mL

Coronary arteriography and cardiac ventriculography

• Concentration (iodine): 300 mg/mL
  • Coronary arteries: 3-7 mL
  • Cardiac ventriculography: 30-45 mL
  • Maximum total dose: 286 mL
• Concentration (iodine): 350 mg/mL
  • Coronary arteries: 3-7 mL
  • Cardiac ventriculography: 30-45 mL
  • Maximum total dose: 245 mL
• Concentration (iodine): 400 mg/mL
  • Coronary arteries: 3-7 mL
  • Cardiac ventriculography: 30-45 mL
  • Maximum total dose: 215 mL

Pediatric dosage

Cerebral arteriography

• Includes intra-arterial digital subtraction angiography (IA-DSA)
• Concentration (iodine): 300 mg/mL
• 0.5-2 mL/kg
• Maximum total dose: 5 mL/kg; not to exceed 200 mL

Visceral and peripheral arteriography and aortography

• Includes IA-DSA
  • Concentration (iodine): 300 mg/mL
  • 0.5-2 mL/kg
  • Maximum total dose: 5 mL/kg; not to exceed 200 mL
  • IDSA
    • Concentration (iodine): 300 mg/mL
    • 0.3-1 mL/kg
    • Maximum total dose: 5 mL/kg; not to exceed 200 mL
• Radiographic evaluation of cardiac chambers and related arteries
  • Concentration (iodine): 300, 350, or 400 mg/mL
  • 0.5-2 mL/kg
  • Maximum total dose: 5 mL/kg
  • Not to exceed
    • 300 mg/mL: 286 mL
    • 350 mg/mL: 245 mL
    • 400 mg/mL: 215 mL

Radiologic imaging (IV procedures)

Adult dosage

• Volume may be immediately followed by 40-50 mL 0.9% NaCl injection flush at the same flow rate as the contrast volume
• Volume may be administered either as a single bolus or for dual-phase protocols as divided doses
• Computed tomography (CT) of the head and body
  • Concentration (iodine): 250 or 300 mg/mL
    • 100-190 mL
    • IV rate: 2-4 mL/sec
  • Concentration (iodine): 350 or 400 mg/mL
    • 75-150 mL
    • IV rate: 2-4 mL/sec
• CT angiography of intracranial, visceral, and lower extremity arteries
  • Concentration (iodine): 350, 350, or 400 mg/mL
    • 80-130 mL
    • IV rate: 4-6 mL sec
• Coronary CT angiography
  • Concentration (iodine): 400 mg/mL
    • 50-90 mL
    • IV rate: 4-6 mL sec
• CT urography
  • Concentration (iodine): 350 mg/mL
    • 90-120 mL
    • IV rate: 2.5 mL/sec

Pediatric dosage

• Computed tomography (CT) of the head and body
  • Concentration (iodine): 250 or 300 mg/mL: 1.5-2.5 mL/k
  • Concentration (iodine): 350 or 400 mg/mL: 1-2 mL/kg
  • IV rate: 1-2 mL sec
• CT angiography of intracranial, visceral, and lower extremity arteries
  • Concentration (iodine): 300, 350, or 400 mg/mL
    • 1-2 mL/kg
    • IV rate: 2-3 mL/sec
• Coronary CT angiography
  • Concentration (iodine): 300 or 400 mg/mL
    • 1-2 mL/kg
    • IV rate: 2-3 mL/sec
• CT urography
  • Concentration (iodine): 300 mg/mL
    • 1-2 mL/kg
    • IV rate: 1-2 mL/sec

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Iomeprol has severe interactions with no other drugs
• Iomeprol has serious interactions with no other drugs
• Iomeprol has moderate interactions with the following drugs:
  • iobenguane I 123
  • iobenguane I 131
  • ioflupane I 123
  • metformin
  • sodium iodide I-131
• Iomeprol has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Iomeprol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Iomeprol?”

Cautions

• Not for intrathecal (IT) administration
  • For intra-arterial or IV use only and must not be administered IT
• Hypersensitivity reactions
  • 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 starting injection (e.g., within 1-3 minutes), but delayed reactions can occur
  • Risk increased with a history of a previous reaction to contrast agents, and known allergic disorders (i.e., bronchial asthma, drug, or food allergies) or other hypersensitivities
  • Premedication with antihistamines or corticosteroids to minimize possible allergic reactions does not prevent serious life-threatening reactions but may reduce their incidence and severity
  • Obtain a history of allergy, hypersensitivity, and hypersensitivity reactions to iodinated contrast agents
  • Always have emergency resuscitation equipment and trained personnel available before use
  • Monitor all patients for hypersensitivity reactions
• Acute kidney injury
  • Acute kidney injury, including renal failure, may occur
  • Risk factors include pre-existing renal impairment, dehydration, diabetes mellitus, heart failure (HF), advanced vascular disease, advanced age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma or other paraproteinemia, and repetitive or large contrast doses
  • Use the lowest necessary dose in patients with renal impairment
  • Adequately hydrate patients before and following administration
  • Do not use laxatives, diuretics, or preparatory dehydration before administration
• Cardiovascular adverse reactions
  • Iomeprol increases circulatory osmotic load and may induce acute or delayed hemodynamic disturbances in patients with HF, severely impaired renal function, combined renal and hepatic disease, or combined renal and cardiac disease, particularly when repetitive or large doses are administered
  • Life-threatening or fatal cardiovascular reactions including hypotension, shock, and cardiac arrest reported
  • Most deaths occur within 10 minutes of injection, with cardiovascular disease as the main underlying factor
  • Cardiac decompensation, serious arrhythmias, and myocardial ischemia or infarction can occur during coronary arteriography and ventriculography
  • Literature reports deaths range from 6.6 per 1 million to 1 in 10,000 patients
  • Use the lowest necessary dose in patients with heart failure and always have emergency resuscitation equipment and trained personnel available
  • Monitor all patients for severe cardiovascular reactions
• Thromboembolic events
  • Serious, in some cases fatal, thromboembolic events including myocardial infarction and stroke can occur during angiographic procedures with iodinated contrast agents
  • During these procedures, increased thrombosis and complement system activation can occur
  • Risk factors include length of procedure, catheter and syringe material, underlying disease state, and concomitant medications
  • Reduce risk by using meticulous angiographic techniques and minimizing procedure duration
  • Avoid blood remaining in contact with syringes containing contrast, which increases clotting risk
  • Avoid angiocardiography in patients with homocystinuria owing to the risk of inducing thrombosis and embolism
• Extravasation and injection site reactions
  • Extravasation can occur, particularly in patients with severe arterial or venous disease
  • Inflammation, blistering, skin necrosis, and compartment syndrome reported following extravasation
  • Additionally, injection site reactions (e.g., pain and swelling at the injection site) can also occur
  • Ensure intravascular catheter placement before injection
  • Monitor for extravasation and advise patients to seek medical care for symptom progression
• Thyroid storm in patients with hyperthyroidism
  • Thyroid storm reported after intravascular use of iodinated contrast agents in patients with hyperthyroidism or with an autonomously functioning thyroid nodule
  • Evaluate risk in such patients before use
  • Thyroid dysfunction in pediatric patients (aged below 3 years)
  • Thyroid dysfunction characterized by hypothyroidism or transient thyroid suppression reported after both single exposure and multiple exposures to iodinated contrast agents in pediatric patients aged birth to 3 years
  • 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 iodinated contrast agent exposure
  • Pediatric patients with congenital cardiac conditions may be at greatest risk as they often require high doses of contrast during invasive cardiac procedures
  • An underactive thyroid during early life may be harmful to cognitive and neurological development and may require thyroid hormone replacement therapy
  • After exposure, individualize thyroid function monitoring based on underlying risk factors, especially in term and preterm neonates
• Hypertensive crisis in patients with pheochromocytoma
  • Hypertensive reported after using iodinated contrast agents in patients with pheochromocytoma
  • Closely monitor if pheochromocytoma or catecholamine-secreting paragangliomas are suspected
  • Inject the minimum amount necessary, assess blood pressure throughout the procedure, and have measures for the treatment of a hypertensive crisis readily available
• Sickle cell crisis
  • When administered intravascularly, iodinated contrast agents may promote sickling in individuals who are homozygous for sickle cell disease
  • Hydrate patients before and following administration and use contrast only if necessary, imaging information cannot be obtained with alternative imaging modalities
• Severe cutaneous adverse reactions
  • Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravascular contrast agent administration, including 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 to patients with a history of SCAR
• Drug interaction overview
  • Metformin
  • Modify metformin administration
  • Stop metformin at the time of, or before, Iomeprol administration with eGFR 30-60 mL/min/1.73 m2, in patients with a history of hepatic impairment, alcoholism, or HF; or in those who will be administered intra-arterial iodinated contrast agents
  • Reevaluate eGFR 48 hr after imaging procedure
  • Reinstitute metformin only after renal function is stable
  • Metformin can cause lactic acidosis with renal impairment
  • Iodinated contrast agents appear to increase the risk of metformin-induced lactic acidosis, possibly owing to worsening renal function
• Radioactive iodine
  • Avoid
    • Avoid thyroid therapy or testing using radioactive iodine for up to 6 weeks post-Iomeprol
    • Iomeprol may interfere with thyroid uptake of radioactive iodine (I-131 and I-123) and decrease therapeutic and diagnostic efficacy
• Protein-bound iodine test
  • Avoid
    • Do not perform protein-bound iodine tests for at least 16 days following Iomeprol administration
    • Iodinated contrast agents temporarily increase protein-bound iodine in the blood
    • However, thyroid function tests that do not depend on iodine estimations (e.g., triiodothyronine [T3] resin uptake and total or free thyroxine [T4] assays) are not affected

Pregnancy and Lactation

• 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
• Lactation
  • Data are unavailable regarding the presence of iomeprol in human milk, its effects on breastfed infants, or its effects on milk production
  • Iomeprol is present in animal milk; when a drug is present in animal milk, it will likely be present in human milk
  • Iodinated contrast agents are excreted unchanged in human milk in very low amounts, with poor GI absorption
  • Interruption of breastfeeding after exposure to iodinated contrast agents is not necessary since the potential exposure of breastfed infants to iodine is small
  • However, a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 10 hours (approximately 5 elimination half-lives) after iomeprol administration to minimize any potential drug exposure