IOMERVU 816 mg/mL
Iomeprol Injection · INJECTION, SOLUTION · BRACCO DIAGNOSTICS INC
IOMERVU is a injection, solution containing iomeprol injection at 816 mg/mL, taken intra-arterial. Manufactured by BRACCO DIAGNOSTICS INC.
Key Facts
- Brand Name
- IOMERVU
- Generic Name
- Iomeprol Injection
- NDC Code (Product)
0270-7018- Manufacturer
- BRACCO DIAGNOSTICS INC
- Strength
- 816 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRA-ARTERIAL, INTRAVENOUS
- Marketing Status
- Application #
- NDA216016
- Drug Class
- Radiographic Contrast Agent [EPC]
- Marketing Start
- 01/01/2026
Recall History
No Recall HistoryFull Prescribing Information
Indications & 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 ) 1.1 Intra-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 pati…
Dosage & 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 ) 2.1 Important 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 …
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Drug Interactions
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 bl…
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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in …
Frequently Asked Questions
What is IOMERVU used for?
IOMERVU contains Iomeprol Injection. It is a injection, solution taken intra-arterial. Consult your doctor for specific uses.
Is IOMERVU a controlled substance?
IOMERVU is not classified as a controlled substance by the DEA.
What is the generic name for IOMERVU?
The generic name for IOMERVU is Iomeprol Injection. There are 10 other brand versions of Iomeprol Injection.
What is the NDC code for IOMERVU 816 mg/mL?
The NDC (National Drug Code) for IOMERVU 816 mg/mL is 0270-7018, listed by BRACCO DIAGNOSTICS INC.