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Iomeprol (United States: Temporary authorization [not FDA approved]): Drug information

Iomeprol (United States: Temporary authorization [not FDA approved]): Drug information
For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Pharmacologic Category
  • Contrast Agent;
  • Iodinated Contrast Media;
  • Radiological/Contrast Media (Nonionic, Low Osmolality)
Dosing: Adult

Note: Not FDA approved; however, due to current critical shortages of FDA-approved contrast agents for intravascular use, the FDA has temporarily authorized importation of Iomeron (iomeprol) into the US market (Spinazzi 2022). Dosing provided is based on the United Kingdom summary of product characteristics.

Note: General dosing guidelines are presented. Doses should be individualized and the lowest dose needed to obtain adequate visualization should be used. Patients should be well hydrated prior to and after administration.

Intravascular imaging

Intravascular imaging:

Angiography:

Angiocardiography and left ventriculography: Iodine 300 mg/mL, 350 mg/mL, 400 mg/mL (single-dose containers only): Intra-arterial: 30 to 80 mL, up to maximum of 250 mL.

Aortography: Iodine 350 mg/mL, 400 mg/mL (single-dose containers only): Intra-arterial: 50 to 80 mL.

Cerebral arteriography: Iodine 250 mg/mL, 300 mg/mL (single-dose containers only): Intra-arterial: 5 to 12 mL; may repeat as necessary.

Coronary arteriography: 350 mg/mL, 400 mg/mL (single-dose containers only): Intra-arterial: 4 to 10 mL per artery; may repeat as necessary.

Peripheral arteriography: Iodine 300 mg/mL, 350 mg/mL, or 400 mg/mL (single-dose containers only): Intra-arterial: 10 to 90 mL; may repeat as necessary.

Visceral arteriography: Iodine 300 mg/mL, 350 mg/mL, 400 mg/mL (single-dose containers only): Intra-arterial: 5 to 50 mL; may repeat as necessary up to maximum 250 mL.

Computed tomography (CT) :

Brain CT: Single-dose containers (iodine 250 mg/mL, 300 mg/mL, 350 mg/mL) or multi-dose containers (iodine 300 mg/mL, 350 mg/mL): IV: 50 to 150 mL.

Whole Body CT: Single-dose containers (iodine 250 mg/mL, 300 mg/mL, 350 mg/mL, 400 mg/mL) or multi-dose containers (iodine 300 mg/mL, 350 mg/mL, 400 mg/mL): IV: 40 to 150 mL, up to maximum of 250 mL.

Digital subtraction angiography :

Aorta: Iodine 250 mg/mL, 300 mg/mL (single-dose containers only): Intra-arterial: 25 to 50 mL; may repeat as necessary up to maximum of 250 mL.

Intravenous: Iodine 250 mg/mL, 300 mg/mL, 350 mg/mL, 400 mg/mL (single-dose containers only): IV: 30 to 60 mL, may repeat as necessary up to maximum of 250 mL.

Peripheral arteriography: Iodine 250 mg/mL, 300 mg/mL (single-dose containers only): Intra-arterial: 5 to 10 mL per artery; may repeat as necessary up to maximum of 250 mL.

Visceral arteriography: Iodine 250 mg/mL, 300 mg/mL (single-dose containers only): Intra-arterial: 2 to 20 mL per artery; may repeat as necessary up to maximum of 250 mL.

Urography : Iodine 250 mg/mL, 300 mg/mL, 350 mg/mL, 400 mg/mL (single-dose containers only): IV: 50 to 150 mL.

Venography: Iodine 250 mg/mL, 300 mg/mL, or 350 mg/mL (single-dose containers only):

Upper extremities: IV: 10 to 50 mL; may repeat as necessary up to maximum of 250 mL.

Lower extremities: IV: 50 to 100 mL; may repeat as necessary up to maximum of 250 mL.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. Use caution in severe impairment and in patients with combined renal and hepatic disease.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. Use caution in patients with combined hepatic and renal disease.

Dosing: Older Adult

Refer to adult dosing. The lowest effective dose should be utilized.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.

>10%: Nervous system: Headache

1% to 10%:

Cardiovascular: Hypertension

Gastrointestinal: Nausea, vomiting

Local: Injection-site reaction (including discomfort at injection site, pain at injection site, swelling at injection site, warm sensation at injection site)

Nervous system: Dizziness, feeling hot

Neuromuscular & skeletal: Back pain, limb pain

<1%:

Cardiovascular: Bradycardia, chest pain, extrasystoles, flushing, hypotension, presyncope, tachycardia

Dermatologic: Erythema of skin, hyperhidrosis, pruritus, skin rash, urticaria

Nervous system: Asthenia, drowsiness, hypoesthesia, loss of consciousness, paresis (paraparesis), paresthesia, rigors

Neuromuscular & skeletal: Muscle rigidity, neck pain

Renal: Increased serum creatinine

Respiratory: Dyspnea

Miscellaneous: Fever

Postmarketing:

Cardiovascular: Acute myocardial infarction, angina pectoris, atrial fibrillation, atrioventricular block, cardiac arrhythmia, circulatory shock, ECG abnormality, heart failure, increased ST segment on ECG, palpitations, shock, syncope, vasodilation, ventricular fibrillation

Dermatologic: Acute generalized exanthematous pustulosis, diaphoresis, erythema multiforme, pallor, Stevens-Johnson syndrome, toxic epidermal necrolysis

Endocrine & metabolic: Hot flash, increased thirst

Gastrointestinal: Abdominal pain, diarrhea, dysgeusia, dysphagia, enlargement of salivary glands, laryngeal discomfort, pancreatitis, sialorrhea

Hematologic & oncologic: Hemolytic anemia, thrombocytopenia

Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction, nonimmune anaphylaxis

Nervous system: Amnesia, anxiety, coma, confusion, dysarthria, fatigue, malaise, paralysis, seizure, sensation of cold, transient ischemic attacks, voice disorder

Neuromuscular & skeletal: Arthralgia

Ophthalmic: Conjunctivitis, increased lacrimation, photopsia, temporary vision loss, visual disturbance

Renal: Renal failure syndrome

Respiratory: Acute respiratory distress syndrome, asthma, bronchospasm, cough, cyanosis, hyperventilation, laryngeal edema, oropharyngeal irritation (discomfort), pharyngeal edema, pulmonary edema, rhinitis

Contraindications

Hypersensitivity to iomeprol or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Allergic reactions: Serious and life-threatening reactions have occurred. Use extreme caution in patients with history of previous reaction to contrast dye, iodine-based contrast media or patients with a known clinical hypersensitivity (eg, bronchial asthma, hay fever, food allergies).

• Contrast-induced acute kidney injury: Acute kidney injury, including renal failure, may occur following administration of iodinated contrast media in patients with preexisting renal disease; other potential risk factors include advanced age, cardiovascular disease, dehydration, diabetes mellitus, diuretic use, hypertension, hyperuricemia, or multiple doses of iodinated contrast media in <24 hours (ACR 2021). Use caution in patients with significant underlying renal impairment and/or, concurrent renal and hepatic impairment, especially when large doses are required. Patients should be well hydrated before and after examination.

• CNS effects: Rare delayed reactions can occur; driving or operating machinery is not recommended for 24 hours following administration.

• Extravasation: May be a vesicant; ensure proper needle or catheter placement prior to and during administration. Monitor infusion site. Avoid infiltration. Extravasation may result in inflammation, tissue necrosis, and/or compartment syndrome.

• Ischemia: Administration via intra-arterial route in coronary or cerebral circulations may induce or aggravate ischemia. Use with caution.

• Seizures: Use with caution in patients with history of epilepsy or at increased risk of seizures (eg, alcohol or drug use disorder, intracranial tumors, or metastasis). There is an increased risk of seizures with intrathecal administration. Antiseizure therapy should be continued.

• Thromboembolic events: Serious, rarely fatal, procedure-related thromboembolic events have been reported during angiographic procedures with both ionic and nonionic contrast media. Clotting may occur when blood remains in contact with syringes containing nonionic contrast media. Use meticulous intravascular administration techniques during angiographic procedures, minimize contact time of blood and contrast media in syringe, and flush catheter frequently to decrease risk.

Disease-related concerns:

• Asthma: Use with caution in patients with asthma; administration of contrast agents may increase risk of bronchospasm.

• Cardiovascular disease: Use with caution in patients with cardiovascular disease or heart failure. Older adults and patients with preexisting heart disease are at increased risk of adverse reactions. Administration of intravascular contrast media injection and fluids during hydration may precipitate worsening pulmonary edema in patients with heart failure. Patients with severe and chronic hypertension are at increased risk of renal damage following administration.

• Cerebrovascular disease: Use caution in patients with a history of cerebrovascular disease (eg, recent stroke, frequent transient ischemic attacks, acute intracranial hemorrhage, brain edema, or acute demyelination). Intravascular injection of contrast media may precipitate cerebral ischemia and increase risk of transient neurological complications. Neurologic symptoms from cerebrovascular pathologies may be exacerbated.

• Electrolyte imbalance: Correct electrolyte imbalances and dehydration prior to administration, especially in patients with multiple myeloma, diabetes mellitus, polyuria, oliguria, hyperuricemia, and in older adults.

• Hepatic impairment: Use with caution in patients with severe hepatic impairment.

• Hyperthyroidism: Reports of delayed hyperthyroidism following administration of iodinated contrast media have occurred in patients with hyperthyroidism or other thyroid disease (ACR 2021). Iodine-binding capacity of thyroid tissue may be reduced for up to 2 weeks following administration of contrast media for diagnosis of thyroid disease; may affect diagnostic tests using iodine-containing isotopes. Use with caution in patients with hyperthyroidism.

• Hypothyroidism: Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been reported; some patients were treated for hypothyroidism.

• Multiple myeloma: Use with caution in patients with multiple myeloma; use of intravascular contrast agents may lead to renal impairment, especially in patients with myelomatosis or paraproteinemias.

• Myasthenia gravis: Use may worsen myasthenia gravis (MG); use with caution and monitor for worsening MG (AAN [Narayanaswami 2021]).

• Pheochromocytoma: Use with extreme caution in patients with pheochromocytoma due to increased risk of hypertensive crisis. Therapy to manage hypertensive crisis should be readily available.

• Renal impairment: Use with caution in patients with renal impairment; may be associated with increased risk of acute renal impairment following administration. Patients should be adequately hydrated prior to and following contrast administration. Additional contrast administration should be delayed, if possible, until renal function returns to preexamination levels.

• Sickle cell disease: Use with caution in patients with homozygous sickle cell disease; administration of contrast media may result in disease exacerbation.

Special populations:

• Older adult: Older adults may be at increased risk of adverse reactions, including myocardial ischemia, arrhythmias, and acute renal insufficiency.

Product Availability

Not FDA approved; however, due to current critical shortages of FDA-approved contrast agents for intravascular use, the FDA has temporary authorized importation of Iomeron (iomeprol) into the US market.

Administration: Adult

Hydrate well prior to and following administration.

Intravascular: Solution should be at body temperature prior to administration. Draw solution from single-dose container into syringe immediately prior to administration. Multi-dose containers (500 mL) may only be used with an automatic injector that is approved for multi-patient use. The bottle stopper should only be pierced one time, and once pierced the multi-dose container must be used within 10 hours. Also refer to automatic injector manufacturer’s instructions.

For angiographic procedures, patient should be lying down and remain supine for at least 30 minutes after the procedure; do not allow media to remain in contact with blood in syringe and use meticulous intravascular administration technique to minimize thrombotic events (including use of plastic syringes and frequent catheter flushing).

May be a vesicant; ensure proper needle or catheter placement prior to and during infusion; avoid infiltration.

Extravasation management: If extravasation occurs, stop infusion immediately and disconnect; remove needle/cannula; elevate extremity. Aspiration of extravasated contrast media is not recommended (ACR 2023). Information conflicts regarding the use of hyaluronidase; the American College of Radiology (ACR) Manual on Contrast Media does not recommend hyaluronidase in the management of contrast media extravasation (ACR 2023); other sources suggest its utility in extravasation management for inoperable cases with compartment syndrome (Stefanos 2023).

If using hyaluronidase: Intradermal or SUBQ: Dose varies based on the size of infiltration; inject a total of 5 to 250 units (~100 mL contrast reabsorbed per 15 units of hyaluronidase) around the site of extravasation (Stefanos 2023).

Use: Labeled Indications

Note: Not FDA approved; however, due to current critical shortages of FDA-approved contrast agents for intravascular use, the FDA has temporarily authorized importation of Iomeron (iomeprol) into the US market (Spinazzi 2022).

Diagnostic imaging: Contrast agent for diagnostic imaging procedures

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Agents With Seizure Threshold Lowering Potential: May enhance the adverse/toxic effect of Iomeprol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iomeprol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic antiseizure drugs. Risk D: Consider therapy modification

Aldesleukin: May enhance the potential for allergic or hypersensitivity reactions to Iodinated Contrast Agents. Risk C: Monitor therapy

Loop Diuretics: May enhance the nephrotoxic effect of Iodinated Contrast Agents. Risk C: Monitor therapy

MetFORMIN: Iodinated Contrast Agents may enhance the adverse/toxic effect of MetFORMIN. Renal dysfunction that may be caused by iodinated contrast agents may lead to metformin-associated lactic acidosis. Management: Management advice varies. Refer to the full drug interaction monograph content for details. Risk D: Consider therapy modification

Sodium Iodide I131: Iodinated Contrast Agents may diminish the therapeutic effect of Sodium Iodide I131. Management: Discontinue iodinated contrast agents before sodium iodide I-131 administration, and avoid concurrent use. Stop water soluble agents 2 months before, and stop lipophilic agents 6 months before, sodium iodide I-131 administration. Risk X: Avoid combination

Reproductive Considerations

Routine pregnancy testing is not required prior to iodinated contrast media use; however, screening may be required based on the procedure (ACR 2021).

Pregnancy Considerations

Iodinated contrast media agents may cross the placenta.

Due to the theoretical concerns that exposure to the free iodide may adversely affect the fetus, use should be avoided unless absolutely required to obtain diagnostic information that will influence the care of the mother or fetus during pregnancy (ACOG 2017; ACR 2021).

Breastfeeding Considerations

Iodinated contrast media may be present in breast milk (ACOG 2017; ACR 2021).

Because of the low expected excretion of iodinated contrast agents into breast milk and the low absorption from an infant’s GI tract, breastfeeding may be continued without interruption after use (ACOG 2017; ACR 2021). Theoretically, the taste of milk could be altered if it contains contrast media. Patients who prefer to temporarily withhold breastfeeding may express and discard from both breasts during a period of 12 to 24 hours after the administration of contrast media. They can pump and store milk prior to the procedure then bottle feed using the stored milk during this time (ACR 2021).

Monitoring Parameters

Monitor renal function, serum electrolytes (prior to procedure); assess thyroid function if transient hypothyroidism is noted. Monitor BP, heart rate, and ECG (when clinically appropriate). Monitor for signs/symptoms of hypersensitivity. Monitor for extravasation during infusion.

Mechanism of Action

Iomeprol is a radiocontrast agent; opacifies vessels in the path of the flow of the contrast medium, permitting radiographic visualization of the internal structures of the body (Pasternak 2014).

Pharmacokinetics (Adult Data Unless Noted)

Half-life elimination: Healthy subjects: IV: 1.9 hours.

Excretion: Urine (unchanged).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Iomeron;
  • (CO) Colombia: Iomeron;
  • (ES) Spain: Iomeron;
  • (GB) United Kingdom: Iomeron;
  • (GR) Greece: Iomeron;
  • (HK) Hong Kong: Iomeron;
  • (IT) Italy: Iomeron;
  • (JP) Japan: Iomeron;
  • (KR) Korea, Republic of: Iomeron;
  • (NL) Netherlands: Iomeron;
  • (NO) Norway: Iomeron;
  • (NZ) New Zealand: Iomeron;
  • (PL) Poland: Iomeron;
  • (TR) Turkey: Iomeron
  1. American College of Obstetricians and Gynecologists (ACOG). Committee opinion no. 723: guidelines for diagnostic imaging during pregnancy and lactation. Obstet Gynecol. 2017;130(4):e210-e216. doi:10.1097/AOG.0000000000002355 [PubMed 30134410]
  2. American College of Radiology (ACR) Committee on Drugs and Contrast Media. ACR manual on contrast media. Version 2021. https://www.acr.org/-/media/ACR/files/clinical-resources/contrast_media.pdf. Published January 2021. Accessed August 19, 2021.
  3. American College of Radiology (ACR) Committee on Drugs and Contrast Media. ACR manual on contrast media. https://www.acr.org/-/media/ACR/Files/Clinical-Resources/Contrast_Media.pdf. Published 2023. Accessed May 17, 2023.
  4. Bellin MF, Jakobsen JA, Tomassin I, et al; Contrast Media Safety Committee Of The European Society Of Urogenital Radiology. Contrast medium extravasation injury: guidelines for prevention and management. Eur Radiol. 2002;12(11):2807-2812. doi:10.1007/s00330-002-1630-9 [PubMed 12386778]
  5. Iomeron 250 (iomeprol) injection [MHRA summary of product characteristics]. Oxford, United Kingdom: Bracco UK Ltd; January 2022.
  6. Iomeron 300 (iomeprol) injection [MHRA summary of product characteristics]. Oxford, United Kingdom: Bracco UK Ltd; January 2022.
  7. Iomeron 300 (iomeprol) injection, multi-dose container [MHRA summary of product characteristics]. Oxford, United Kingdom: Bracco UK Ltd; November 2021.
  8. Iomeron 350 (iomeprol) injection [MHRA summary of product characteristics]. Oxford, United Kingdom: Bracco UK Ltd; January 2022.
  9. Iomeron 400 (iomeprol) injection [MHRA summary of product characteristics]. Oxford, United Kingdom: Bracco UK Ltd; January 2022.
  10. Iomeron 400 (iomeprol) injection, multi-dose container [MHRA summary of product characteristics]. Oxford, United Kingdom: Bracco UK Ltd; November 2021.
  11. Narayanaswami P, Sanders DB, Wolfe G, et al. International consensus guidance for management of myasthenia gravis: 2020 update. Neurology. 2021;96(3):114-122. doi:10.1212/WNL.0000000000011124 [PubMed 33144515]
  12. Pasternak JJ, Williamson EE. Clinical pharmacology, uses, and adverse reactions of iodinated contrast agents: a primer for the non-radiologist. Mayo Clin Proc. 2012;87(4):390-402. doi:10.1016/j.mayocp.2012.01.012 [PubMed 22469351]
  13. Spinazzi A. Dear healthcare provider letter: Temporary importation of Iomeron (iomeprol injection) to address drug shortage issues. Bracco Diagnostics Inc; July 2022.
  14. Stefanos SS, Kiser TH, MacLaren R, Mueller SW, Reynolds PM. Management of noncytotoxic extravasation injuries: a focused update on medications, treatment strategies, and peripheral administration of vasopressors and hypertonic saline. Pharmacotherapy. 2023;43(4):321-337. doi:10.1002/phar.2794 [PubMed 36938775]
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