Iomeprol

IOMERVU is a radiographic contrast agent indicated for: Intra-arterial Procedures †. 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 †. 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.

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.

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. See full prescribing information for complete dosage and administration information.

None. None

Boxed 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. Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency resuscitation equipment and trained personnel available. Acute Kidney Injury: Acute injury including renal failure can occur. Minimize dose and maintain adequate hydration to minimize risk. Cardiovascular Adverse Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after administration.

The following clinically significant adverse reactions are described elsewhere in the labeling: Risks Associated with Intrathecal Administration Hypersensitivity Reactions Acute Kidney Injury Cardiovascular Adverse Reactions Thromboembolic Events Extravasation and Injection Site Reactions Thyroid Dysfunction in Pediatric Patients 0 Years to 3 Years of Age Severe Cutaneous Adverse Reactions Most common adverse reactions (incidence ≥0.5%) are feeling hot, headache, nausea, chest pain, back pain, and vomiting.

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.

Store at 20°C to 25°C (68°F to 77°F). Do not freeze. Keep in original carton with the cover closed to protect from light.