IOMERVU Iomeprol Injection 816 mg/mL Injection, Solution — NDC 0270-7018-29 (Billing 00270-7018-29)
This is a package of IOMERVU Iomeprol Injection 816 mg/mL Injection, Solution from BRACCO DIAGNOSTICS INC, marketed since Jan 2026 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 0270-7018-29 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0270 labeler · 7018 product · 29 package
- Package marketed since
- Jan 1, 2026
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 0270701829 7
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
- It is a contrast dye that makes your blood vessels and organs show up clearly on X-ray or CT scans. It does not treat a condition. It helps your doctors see what is going on.
- A trained professional injects it into an artery or a vein during your scan. The amount is chosen for your age, weight and the area being imaged. You should drink fluids as directe...
- The most common are feeling hot, headache, nausea, chest pain, back pain and vomiting. Tell staff right away if you have trouble breathing, swelling, or severe dizziness. Report ra...
- It can be. Metformin may need to be stopped at or before the scan, especially with reduced kidney function, liver problems, alcoholism, heart failure, or an artery injection. Your...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00270-7018-27 0270-7018-27 Main listing | 10 BOTTLE, GLASS in 1 CASE / 100 mL in 1 BOTTLE, GLASS | 2026-01-01 | — | Active |
| 00270-7018-29 You're viewing this | 10 BOTTLE, GLASS in 1 CASE / 200 mL in 1 BOTTLE, GLASS | 2026-01-01 | — | Active |
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of IOMERVU Iomeprol Injection 816 mg/mL Injection, Solution?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Iomervu 816 mg/mLthis 00270-7018-29 | BRACCO | 10 bottles | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Code | What it grants | Expires |
|---|---|---|
| NCE | New Chemical Entity (5-year) | Nov 27, 2029 |
| NCE | New Chemical Entity (5-year) | Nov 27, 2029 |
| NCE | New Chemical Entity (5-year) | Nov 27, 2029 |
| NCE | New Chemical Entity (5-year) | Nov 27, 2029 |
| NCE | New Chemical Entity (5-year) | Nov 27, 2029 |
| NCE | New Chemical Entity (5-year) | Nov 27, 2029 |
| NCE | New Chemical Entity (5-year) | Nov 27, 2029 |
| NCE | New Chemical Entity (5-year) | Nov 27, 2029 |
| NCE | New Chemical Entity (5-year) | Nov 27, 2029 |
| NCE | New Chemical Entity (5-year) | Nov 27, 2029 |
| NCE | New Chemical Entity (5-year) | Nov 27, 2029 |
| NCE | New Chemical Entity (5-year) | Nov 27, 2029 |
| NCE | New Chemical Entity (5-year) | Nov 27, 2029 |
Is there a generic version of this drug?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Iomeprol Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from BRACCO DIAGNOSTICS INC labeler code 00270
- ISOVUE-M IOPAMIDOL 408 mg/mL Injection, Solution NDC 0270-1411-11
- ISOVUE-M IOPAMIDOL 612 mg/mL Injection, Solution NDC 0270-1412-15
- MultiHance gadobenate dimeglumine 529 mg/mL Injection, Solution NDC 0270-5164-12
- MultiHance gadobenate dimeglumine 529 mg/mL Injection, Solution NDC 0270-5264-16
- Vueway Gadopiclenol 485.1 mg/mL Injection NDC 0270-7015-46
- IOMERVU Iomeprol Injection 714 mg/mL Injection, Solution NDC 0270-7017-21
- Vueway Gadopiclenol 485.1 mg/mL Injection NDC 0270-7020-38
- Vueway Gadopiclenol 485.1 mg/mL Injection NDC 0270-7025-40
- Vueway Gadopiclenol 485.1 mg/mL Injection NDC 0270-7030-42
- Vueway Gadopiclenol 485.1 mg/mL Injection NDC 0270-7035-44
- Lumason SULFUR HEXAFLUORIDE 60.7 mg/mg; .19 mg/mg; 1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHO-(1'-RAC-GLYCEROL) .19 mg/mg Injection, Powder, Lyophilized, For Suspension NDC 0270-7097-07
- LumaSon SULFUR HEXAFLUORIDE Kit NDC 0270-7099-16
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 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)
🎯 Indications and Usage ▾
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.
( 2.2 , 2.3 , 2.4 , 2.5 )
1.1Intra-arterial Procedures † IOMERVU is indicated for: Cerebral arteriography, including intra-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
1.2Intravenous Procedures † IOMERVU is indicated for: 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 of IOMERVU are recommended for each type of imaging procedure [see Dosage and Administration ( 2.2 , 2.3 , 2.4 , 2.5 )] .
⏱️ Dosage and Administration ▾
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 )
2.1Important 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.
2.2Recommended 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
2.3Recommended 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
2.4Recommended Dosage for Intravenous Procedures… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: clear, colorless to pale yellow solution available in the following iodine concentrations and configurations: Concentration (mg Iodine/mL) Package Size Package Type 250 100 mL Single-dose bottles 300 50 mL Single-dose vials 100 mL, 150 mL, and 200 mL Single-dose bottles 350 50 mL Single-dose vials 100 mL, 150 mL, and 200 mL Single-dose bottles 400 50 mL Single-dose vials 100 mL, 150 mL, and 200 mL Single-dose bottles Injection: 250 mg Iodine/mL, 300 mg Iodine/mL, 350 mg Iodine/mL, and 400 mg Iodine/mL in single-dose vials or bottles ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency resuscitation equipment and trained personnel available. ( 5.2 ) Acute Kidney Injury: Acute injury including renal failure can occur.
Minimize dose and maintain adequate hydration to minimize risk. ( 5.3 ) Cardiovascular Adverse Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after administration. ( 5.4 ) Thyroid Dysfunction in Pediatric Patients 0 Years to 3 Years of Age: Individualize thyroid function monitoring based on risk factors such as prematurity.
( 5.8 )
5.1Risks Associated with Inadvertent Intrathecal Administration IOMERVU is for intra-arterial or intravenous use only and must not be administered intrathecally [see Dosage and Administration ( 2.1 )]. 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.
5.2Hypersensitivity Reactions IOMERVU can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock [see Adverse Reactions ( 6.2 )]. Most severe reactions develop shortly after the start of injection (e.g., within 1 to 3 minutes), but delayed reactions can occur.
There is an increased risk in patients 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 of IOMERVU. Monitor all patients for hypersensitivity reactions.
5.3Acute Kidney Injury Acute kidney injury, including renal failure, may occur after IOMERVU administration. Risk factors include pre-existing renal impairment, dehydration, diabetes mellitus, heart failure, advanced vascular disease, advanced age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma or other paraproteinemia, and repetitive or large doses of IOMERVU. Use the lowest necessary dose of IOMERVU in patients with renal impairment.
Adequately hydrate patients prior to and following IOMERVU administration. Do not use laxatives, diuretics, or preparatory dehydration prior to IOMERVU administration.
5.4Cardiovascular Adverse Reactions IOMERVU increases the circulatory osmotic load and may induce acute or delayed hemodynamic disturbances in patients with heart failure, 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 have occurred with the use of IOMERVU. 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. Based upon literature reports, deaths from the administration of iodinated contrast agents range from 6.6 per 1 million (0.00066 percent) to 1 in 10,000 patients (0.01 percent). Use the lowest necessary dose of IOMERVU in patients with heart failure and always have emergency resuscitation equipment and trained personnel available.
Monitor all patients for severe cardiovascular reactions.
5.5Thromboembolic Events Serious, in some cases fatal, thromboembolic events including myocardial infarction and stroke can occur d… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: 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 Years 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 ≥0.5%) are feeling hot, headache, nausea, chest pain, back pain, and vomiting.
( 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.
6.1Clinical 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 Adult Patients The safety of IOMERVU was evaluated in 4,621 adult patients who received 1,500 mg to 86,000 mg iodine doses of IOMERVU intra-arterially or intravenously in clinical trials. The average age was 60 years (range 18 years to 99 years), and 34% were female.
The racial and ethnic distribution was 83% White, 10% Asian, 1% Black, 1% Hispanic, and 5% patients of other or unspecified groups. Table 5 provides a summary of the adverse reactions reported in ≥0.5% of adult patients. Table 5: Adverse Reactions Reported in ≥0.5% of 4,621 Adult Patients Receiving Intra-arterial or Intravenous Administration of IOMERVU in Clinical Trials Adverse Reaction Incidence (%) Feeling hot 2 Headache
1.2 Nausea 1 Chest pain
0.6 Back pain
0.5 Vomiting
0.5The following adverse reactions were observed in <0.5% of the adult patients receiving IOMERVU: Blood and lymphatic system disorders: activated partial thromboplastin time prolonged, prothrombin time prolonged Cardiovascular disorders: ventricular fibrillation, hypertensive crisis, coronary arteriospasm, congestive cardiac failure, cardiac flutter, atrioventricular block, right bundle branch block, hypotension, arrhythmia, bradycardia, supraventricular extrasystoles, ventricular extrasystoles, increased blood pressure, flushing Ear and labyrinth disorders : vertigo, ear discomfort Eye disorder: vision blurred, periorbital edema, photopsia Gastrointestinal : esophageal varices hemorrhage, abdominal pain, abdominal distension, alanine aminotransferase (ALT) increased, constipation, diarrhea, dry mouth, salivary hypersecretion, oral paresthesia General disorders: pain, injection site reactions (pain, discomfort, or warmth), peripheral edema, chills, asthenia, malaise Musculoskeletal and connective tissue disorders: arthralgia, pain in jaw Nervous system disorders: cerebrovascular disorder, dysarthria, visual field defect, burning sensation, presyncope, dizziness, dysgeusia, paresthesia Psychiatric disorders : delirium, anxiety, insomnia Renal and urinary disorders: acute kidney injury, increased blood creatinine, urinary urgency Respiratory, thoracic, and mediastinal disorders: respiratory arrest, pulmonary edema, bronchospasm, dyspnea, cough, rhinitis, throat irritation or tightness, sneezing Skin and subcutaneous tissue disorders: urticaria, blister, purpura, ecchymosis, rash, pruritus, erythema Adverse Reactions in Pediatric Patients The safety of IOMERVU was evaluated in 184 pediatric patients who received 1,800 mg to 76,000 mg iodine doses of IOMERVU intra-arterially or intravenously in clinical trials.
The average age was 6 years (range 11 days to 17 years), and 47% were female. The racial distribution… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1Drug-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.
7.2Drug-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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: A lactating woman may pump and discard breast milk for 10 hours after IOMERVU administration. ( 8.2 )
8.1Pregnancy 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.
8.2Lactation Risk Summary There are no data on the presence of iomeprol in human milk, the effects on the breastfed infant, or the effects on milk production. Iomeprol is present in animal milk (see Data) . When a drug is present in animal milk, it is likely that the drug will be present in human milk.
Iodinated contrast agents are excreted 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 IOMERVU and any potential adverse effects on the breastfed infant from IOMERVU 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 elimination half-lives) after IOMERVU administration to minimize any potential drug exposure to a breastfed infant. Data An animal study with a single intravenous administration of 500 mg iodine/kg (0.06-fold the HED using the maximum human dose of 86,000 mg iodine per administration) of radiolabeled iomeprol to lactating rats showed that iomeprol rapidly distributed into the milk.
8.4Pediatric Use Intra-arterial Use The safety and effectiveness of IOMERVU have been established in pediatric patients for cerebral, visceral, and peripheral arteriography, aortography including intra-arterial digital subtraction angiography, and radiographic evaluation of cardiac chambers and related arteries. Use of IOMERVU is supported by evidence from adequate and well-controlled studies of IOMERVU in adults, pharmacokinetic data in pediatric patients aged 3 years to 17 years, pharmacokinetic… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy 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.
🧒 Pediatric Use ▾
8.4Pediatric Use Intra-arterial Use The safety and effectiveness of IOMERVU have been established in pediatric patients for cerebral, visceral, and peripheral arteriography, aortography including intra-arterial digital subtraction angiography, and radiographic evaluation of cardiac chambers and related arteries. Use of IOMERVU is supported by evidence from adequate and well-controlled studies of IOMERVU in adults, pharmacokinetic data in pediatric patients aged 3 years to 17 years, pharmacokinetic simulation in pediatric patients younger than 3 years of age, and safety data obtained in 44 pediatric patients including 29 who were < 2 years of age, 14 children (2 years to 11 years), and 1 adolescent (12 years to 17 years).
In general, adverse reactions reported in pediatric patients were similar to those in adults [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14.1 )] . Intravenous Use The safety and effectiveness of IOMERVU have been established in pediatric patients for CT of the head and body, CT angiography of intracranial, visceral, and lower extremity arteries, coronary CT angiography, and CT urography. Use of IOMERVU is supported by evidence from adequate and well-controlled studies of IOMERVU in adults, pharmacokinetic data in pediatric patients aged 3 years to 17 years, pharmacokinetic simulation in pediatric patients younger than 3 years of age, and safety data obtained in 140 pediatric patients including 22 who were < 2 years of age, 92 children (2 years to 11 years), and 26 adolescents (12 years to 17 years).
In general, adverse reactions reported in pediatric patients were similar to those in adults [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14.2 )] . Intra-arterial and Intravenous Use Pediatric patients at higher risk of experiencing an adverse reaction during and after administration of any contrast agent may include those with asthma, sensitivity to medication and/or allergens, cyanotic and acyanotic heart disease, heart failure, or serum creatinine greater than 1.5 mg/dL, or those less than 12 months of age.
Pediatric patients with immature renal function or dehydration may be at increased risk for adverse events due to slower elimination of iodinated contrast agents [See Clinical Pharmacology ( 12.3 )]. Thyroid function tests indicative of thyroid dysfunction, characterized by hypothyroidism or transient thyroid suppression have been reported following iodinated contrast agent administration in pediatric patients, including term and preterm neonates. Some patients were treated for hypothyroidism.
After exposure to iodinated contrast agents, 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 Warnings and Precautions (5.8) and Adverse Reactions ( 6.2 )].
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of subjects in clinical studies of IOMERVU, 1,977 (43%) patients were 65 years and older, while 629 (14%) patients were 75 years and older. No overall differences in safety or effectiveness were observed between these patients and younger patients. Iomeprol is excreted by the kidneys, and the risk of adverse reactions to IOMERVU is greater in patients with renal impairment.
Because elderly patients 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 )] .
🆘 Overdosage ▾
10 OVERDOSAGE The adverse effects of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular systems. Treatment of an overdosage is directed toward the support of all vital functions and prompt institution of symptomatic therapy. Iomeprol can be removed by dialysis [see Clinical Pharmacology ( 12.3 )] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Iomeprol is a radiographic iodinated contrast agent that opacifies the vessels and body structures where the contrast agent is present following intravenous or intra-arterial administration, permitting radiographic visualization of the internal structures through attenuation of X-ray photons. In imaging of the body, iodinated contrast agents diffuse from the vessels into the extravascular space. In normal brain with an intact blood-brain barrier, the contrast agent does not diffuse into the extravascular space and contrast enhancement is generally due to the presence of contrast within the vascular space.
In patients with a disrupted blood-brain barrier, the contrast agent accumulates in the extravascular space in the region of disruption.
12.2Pharmacodynamics The degree of radiographic enhancement by iomeprol is related to the iodine concentration in the tissue of interest following the administration of IOMERVU. However, the exposure-response relationships and time course of pharmacodynamic response of iomeprol have not been fully characterized.
12.3Pharmacokinetics The pharmacokinetic parameters of iomeprol are presented as mean (standard deviation, SD) unless otherwise specified. The maximum concentration (C max ) and area under the concentration-time curve (AUC) are dose-proportional across the dose range of 250 mg iodine/kg to 1,250 mg iodine/kg body weight. Distribution The volume of distribution of iomeprol is 0.28 (0.05) L/kg.
Iomeprol does not bind to plasma proteins. Elimination The elimination half-life of iomeprol is 1.8 (0.33) hours and the total body clearance is 0.10 (0.01) L/hr/kg. Metabolism Iomeprol does not undergo significant metabolism.
Excretion Approximately 90% of the iomeprol dose is excreted unchanged in urine within 24 hours. Specific Populations Pediatric Patients No clinically significant differences in the pharmacokinetics of iomeprol were observed in pediatric patients aged 3 years to 17 years compared to adult patients who received IOMERVU. No clinically significant differences in C max and concentration of iomeprol within 5 minutes after IOMERVU administration between pediatric patients younger than 3 years of age and adults are expected based on pharmacokinetic simulations.
Patients with Renal Impairment The renal clearance of iomeprol decreased by 28% in patients with mild (GFR 51 − 75 mL/min, estimated by inulin clearance (CL inulin )), 66% with moderate (GFR 26 − 50 mL/min, by CL inulin ), and 84% with severe (GFR ≤ 25 mL/min, by CL inulin ) renal impairment. Similarly, mean half-life increased 1.6-fold in mild, 2.9-fold in moderate, and 6.4-fold in severe renal impairment. Iomeprol is dialyzable.
Iomeprol plasma concentrations decreased by 83% in patients with severe renal impairment who underwent hemodialysis 2 hours after a single administration of a 20,000 mg iodine dose of IOMERVU by intravenous route.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Iomeprol is a radiographic iodinated contrast agent that opacifies the vessels and body structures where the contrast agent is present following intravenous or intra-arterial administration, permitting radiographic visualization of the internal structures through attenuation of X-ray photons. In imaging of the body, iodinated contrast agents diffuse from the vessels into the extravascular space. In normal brain with an intact blood-brain barrier, the contrast agent does not diffuse into the extravascular space and contrast enhancement is generally due to the presence of contrast within the vascular space.
In patients with a disrupted blood-brain barrier, the contrast agent accumulates in the extravascular space in the region of disruption.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied IOMERVU (iomeprol) injection is a clear, colorless to pale yellow solution supplied in clear glass single-dose vials or bottles in the following configurations: Concentration (mg Iodine/mL) Packages Size Package Type Sale Unit NDC 250 100 mL Single-dose bottles Carton of 10 0270-7013-14 300 50 mL Single-dose vials Carton of 10 0270-7016-15 100 mL Single-dose bottles Carton of 10 0270-7016-17 150 mL Carton of 10 0270-7016-18 200 mL Carton of 10 0270-7016-19 350 50 mL Single-dose vials Carton of 10 0270-7017-20 100 mL Single-dose bottles Carton of 10 0270-7017-21 150 mL Carton of 10 0270-7017-24 200 mL Carton of 10 0270-7017-25 400 50 mL Single-dose vials Carton of 10 0270-7018-26 100 mL Single-dose bottles Carton of 10 0270-7018-27 150 mL Carton of 10 0270-7018-28 200 mL Carton of 10 0270-7018-29 Storage and Handling Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
Keep in original carton with the cover closed to protect from light. Do not freeze.
📋 Description ▾
11 DESCRIPTION IOMERVU (iomeprol) injection is a tri-iodinated, non-ionic radiographic contrast agent for intra-arterial or intravenous use. It is provided as a sterile, nonpyrogenic, clear, colorless to pale yellow solution. The chemical name for iomeprol is N,N’-bis(2,3-dihydroxypropyl)-5-[(hydroxyacetyl)-methylamino]-2,4,6-tri-iodo-1,3-benzenedicarboxamide.
Iomeprol has a molecular formula of C 17 H 22 I 3 N 3 O 8 , a molecular weight of 777.09 (iodine content of 49%), and the following structural formula: IOMERVU injection is available in four iodine concentrations: IOMERVU 250 mg Iodine/mL: Each mL contains 510 mg iomeprol (providing 250 mg bound iodine) and 1 mg tromethamine. IOMERVU 300 mg Iodine/mL: Each mL contains 612 mg iomeprol (providing 300 mg bound iodine) and 1 mg tromethamine. IOMERVU 350 mg Iodine/mL: Each mL contains 714 mg iomeprol (providing 350 mg bound iodine) and 1 mg tromethamine.
IOMERVU 400 mg Iodine/mL: Each mL contains 816 mg iomeprol (providing 400 mg bound iodine) and 1 mg tromethamine. The pH of IOMERVU has been adjusted to 6.5 to 7.2 with hydrochloric acid. Physical characteristics are noted in Table 6.
IOMERVU has osmolalities approximately 1.5 to 2.5 times that of plasma (285 mOsm/kg water) as shown in the table below and are hypertonic under conditions of use. Table 6. Physical Characteristics of IOMERVU Concentration (mg Iodine/mL) Density (d 20 4 ± 0.0002) Osmolality (mOsmol/kg) Viscosity (mPa·s) 37°C 20°C 37°C 250 1.278 435 4.9 2.9 300 1.334 521 8.1 4.5 350 1.390 618 14.5 7.5 400 1.446 726 27.5
12.6 Iomeprol-Structural-Formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Hypersensitivity Reactions Advise the patient concerning the risk of hypersensitivity reactions that can occur both during and after IOMERVU 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 IOMERVU [see Warnings and Precautions ( 5.11 )].
Acute Kidney Injury Advise the patient concerning appropriate hydration to decrease the risk of 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 or caregivers about the risk of developing thyroid dysfunction after IOMERVU administration.
Advise parents or caregivers about when to seek medical care for their child to monitor for thyroid dysfunction [see Warnings and Precautions ( 5.8 )] . Lactation Advise a lactating woman that interruption of breastfeeding is not necessary, however, to avoid any exposure a lactating woman may consider pumping and discarding breast milk for 10 hours after IOMERVU administration [see Use in Specific Populations ( 8.2 )]. Manufactured for Bracco Diagnostic Inc.
Princeton, NJ 08540 Manufactured by BIPSO GmbH 78224 Singen (Germany)
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics The pharmacokinetic parameters of iomeprol are presented as mean (standard deviation, SD) unless otherwise specified. The maximum concentration (C max ) and area under the concentration-time curve (AUC) are dose-proportional across the dose range of 250 mg iodine/kg to 1,250 mg iodine/kg body weight. Distribution The volume of distribution of iomeprol is 0.28 (0.05) L/kg.
Iomeprol does not bind to plasma proteins. Elimination The elimination half-life of iomeprol is 1.8 (0.33) hours and the total body clearance is 0.10 (0.01) L/hr/kg. Metabolism Iomeprol does not undergo significant metabolism.
Excretion Approximately 90% of the iomeprol dose is excreted unchanged in urine within 24 hours. Specific Populations Pediatric Patients No clinically significant differences in the pharmacokinetics of iomeprol were observed in pediatric patients aged 3 years to 17 years compared to adult patients who received IOMERVU. No clinically significant differences in C max and concentration of iomeprol within 5 minutes after IOMERVU administration between pediatric patients younger than 3 years of age and adults are expected based on pharmacokinetic simulations.
Patients with Renal Impairment The renal clearance of iomeprol decreased by 28% in patients with mild (GFR 51 − 75 mL/min, estimated by inulin clearance (CL inulin )), 66% with moderate (GFR 26 − 50 mL/min, by CL inulin ), and 84% with severe (GFR ≤ 25 mL/min, by CL inulin ) renal impairment. Similarly, mean half-life increased 1.6-fold in mild, 2.9-fold in moderate, and 6.4-fold in severe renal impairment. Iomeprol is dialyzable.
Iomeprol plasma concentrations decreased by 83% in patients with severe renal impairment who underwent hemodialysis 2 hours after a single administration of a 20,000 mg iodine dose of IOMERVU by intravenous route.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics The degree of radiographic enhancement by iomeprol is related to the iodine concentration in the tissue of interest following the administration of IOMERVU. However, the exposure-response relationships and time course of pharmacodynamic response of iomeprol have not been fully characterized.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Intra-arterial Studies Cerebral arteriography was evaluated in one blinded read study incorporating two prospective, randomized, double-blind, multi-center clinical studies of 61 adult patients (35 male, 26 female) who were administered IOMERVU 300 mg Iodine/mL by intra-arterial route. The mean age was 52 years (range 17 years to 86 years), and 23% of patients were ≥65 years old. The mean total iodine dose administered was 29,000 mg.
The racial and ethnic representations were 62% White, 15% Black, 20% Hispanic, and 3% Asian. Visualization was independently assessed as adequate or inadequate by three blinded readers. Visualization was rated as adequate in 100% of patients.
Visceral and peripheral arteriography were evaluated in one blinded read study incorporating two prospective, randomized, double-blind, multi-center clinical studies of 60 adult patients (36 male, 24 female) who were administered IOMERVU 300 mg Iodine/mL by intra-arterial route. The mean age was 67 years (range 29 years to 95 years) and 62% of patients were ≥65 years old. The mean total iodine dose administered was 48,000 mg.
The racial and ethnic representations were 92% White, 7% Black, and 1% Hispanic. Visualization was independently assessed as adequate or inadequate by three blinded readers. Visualization was rated as adequate in 98% of patients.
Similar cerebral arteriography, visceral arteriography, and peripheral arteriography studies with digital subtraction angiography (DSA) were completed with comparable findings. Coronary arteriography and cardiac ventriculography were evaluated in one blinded read study incorporating four prospective, randomized, double-blind, multi-center clinical studies of 59 adult patients (41 male, 18 female) who were administered IOMERVU 400 mg Iodine/mL, and 59 adult patients (43 male, 16 female) who were administered IOMERVU 300 mg Iodine/mL by intra-arterial route.
The mean age was 60 years (range 22 years to 85 years), and 42% of patients were ≥65 years old. The mean total iodine dose administered was 45,000 mg. The racial and ethnic representations were 75% White, 15% Black, 6% Hispanic, 1% Asian, and 3% other racial or ethnic groups.
Visualization was independently assessed as adequate or inadequate by three blinded readers. Visualization was rated as adequate in 93% - 100% of patients for both concentrations.
14.2Intravenous Studies CT of the head and body was evaluated in one blinded read study incorporating four prospective, randomized, double-blind, multi-center clinical studies of 59 adult patients (22 male, 37 female) who were administered IOMERVU 400 mg Iodine/mL and 59 adult patients (26 male, 33 female) who were administered IOMERVU 250 mg Iodine/mL by intravenous route. The mean age was 55 years (range 19 years to 80 years), and 30% of patients were ≥65 years old. The mean total iodine dose administered was 41,000 mg.
The racial and ethnic representations were 78% White, 16% Black, 4% Hispanic, 1% Asian, and 1% other racial or ethnic groups. Visualization was independently assessed as adequate or inadequate by three blinded readers. Visualization was rated as adequate in 98% - 100% of patients for both concentrations.
CT angiography was evaluated in two prospective, single-center clinical studies enrolling a total of 262 adult patients (202 male, 60 female) with suspected or known peripheral arterial disease who were administered IOMERVU 400 mg Iodine/mL by intravenous route. The mean age was 62 years (range 36 years to 88 years). Both studies assessed the diagnostic performance for detection of significant stenosis at the arterial segment level using digital subtraction angiography as the reference standard.
In the first study, 212 patients (7,392 segments, 42% positive by reference standard) were independently evaluated by three blinded readers. The reported segment-level sensitivity and specificity (95% confidence interval) for the detection of ≥70% stenosis were 99% (98%, 99%) a… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No carcinogenicity studies of iomeprol have been conducted. Mutagenesis Iomeprol did not demonstrate mutagenic or clastogenic potential in an in vitro bacterial reverse mutation assay (Ames test) or in an in vivo rat bone marrow micronucleus assay. Impairment of Fertility Iomeprol did not impair the fertility of male or female rats when intravenously administered at doses up to 0.45-times the maximum recommended human dose.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No carcinogenicity studies of iomeprol have been conducted. Mutagenesis Iomeprol did not demonstrate mutagenic or clastogenic potential in an in vitro bacterial reverse mutation assay (Ames test) or in an in vivo rat bone marrow micronucleus assay. Impairment of Fertility Iomeprol did not impair the fertility of male or female rats when intravenously administered at doses up to 0.45-times the maximum recommended human dose.
📄 Package Label / Principal Display Panel ▾
Iomervu Labels iomervu-ia-iv-350-200ml-internal iomervu-ia-iv-350-150ml-internal iomervu-ia-iv-350-100ml-internal iomervu-ia-iv-350-50ml-internal iomervu-ia-iv-350-10X200ml-external iomervu-ia-iv-350-10X150ml-external iomervu-ia-iv-350-10X100ml-external iomervu-ia-iv-350-10X50ml-external iomervu-ia-iv-400-200ml-internal iomervu-ia-iv-400-150ml-internal iomervu-ia-iv-400-100ml-internal iomervu-ia-iv-400-50ml-internal iomervu-ia-iv-400-10X200ml-external iomervu-ia-iv-400-10X150ml-external iomervu-ia-iv-400-10X100ml-external iomervu-ia-iv-400-10X50ml-external
Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |