RENOVIST II
Clinical safety rating: caution
Comprehensive clinical and safety monograph for RENOVIST II (RENOVIST II).
RENOVIST II is a radiographic contrast agent that contains diatrizoate meglumine and diatrizoate sodium. It increases the radiopacity of vascular structures and organs by attenuating X-rays due to the high atomic number of iodine atoms in the molecule.
| Metabolism | Primarily excreted unchanged by the kidneys via glomerular filtration; negligible metabolism. |
| Excretion | Renal: 95% as unchanged drug via glomerular filtration; fecal: <5%. |
| Half-life | 1.2 hours in patients with normal renal function; prolonged to 8–12 hours in severe renal impairment (CrCl <30 mL/min). |
| Protein binding | <1% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | 0.3–0.4 L/kg, indicating distribution primarily in extracellular fluid. |
| Bioavailability | Not applicable; administered only via intravenous or intra-arterial injection (100% systemic availability). |
| Onset of Action | Intravenous: immediate (within 1 minute); intra-arterial: within seconds after injection. |
| Duration of Action | Rapid redistribution yields diagnostic imaging window of 30–60 minutes for CT; prolonged in renal impairment due to delayed excretion. |
1-2 mL/kg IV bolus, not to exceed 150 mL total; may be repeated once if necessary.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in patients with GFR <30 mL/min/1.73 m². For GFR 30-59 mL/min/1.73 m², use minimum volume necessary; ensure adequate hydration. |
| Liver impairment | No specific dose adjustment required for hepatic impairment. Use caution in severe hepatic disease due to risk of delayed clearance. |
| Pediatric use | 1-2 mL/kg IV bolus; maximum dose 150 mL. Not recommended for neonates due to high osmolality. |
| Geriatric use | Use minimum effective dose; monitor renal function closely due to age-related decline in GFR. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for RENOVIST II (RENOVIST II).
| Breastfeeding | Iodinated contrast agents like RENOVIST II are excreted into breast milk in minimal amounts (M/P ratio unknown but likely <1). The very small quantity absorbed by the infant is unlikely to cause adverse effects, including thyroid dysfunction. The American College of Radiology states that breastfeeding can continue without interruption after administration of iodinated contrast, but some clinicians recommend discarding milk for 12-24 hours as a precaution. No dose adjustment is needed. |
| Teratogenic Risk | RENOVIST II (diatrizoate meglumine and diatrizoate sodium) is an iodinated radiographic contrast agent. In pregnant women, exposure to ionizing radiation should be minimized due to potential teratogenic effects, especially during organogenesis (first trimester). However, the contrast agent itself is not known to be teratogenic in humans. Limited data suggest no increased risk of congenital anomalies with diagnostic use. Second and third trimester exposure is associated with transient neonatal hypothyroidism if high doses are used, though risk is low with standard doses. Generally, the benefit of diagnostic information outweighs theoretical risks. |
■ FDA Black Box Warning
Not to be used for intrathecal administration due to risk of severe adverse reactions including convulsions, brain hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and death.
| Serious Effects |
["Hypersensitivity to diatrizoate or any component","Intrathecal administration","Sickle cell disease (risk of sickling)"]
| Precautions | Risk of contrast-induced acute kidney injury (CI-AKI) in patients with pre-existing renal impairment, diabetes mellitus, dehydration, or concurrent nephrotoxic drug therapy. Ensure adequate hydration before administration. Avoid extravasation due to risk of tissue necrosis. |
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| Fetal Monitoring | Maternal: Monitor for allergic reactions, nephrotoxicity (serum creatinine, BUN), and thyroid function in patients with pre-existing thyroid disease. Fetal: If significant radiation exposure occurs, consider fetal radiation dose estimation and consult radiology. Monitor for neonatal hypothyroidism if high doses were used near term. No routine fetal monitoring required for standard diagnostic use. |
| Fertility Effects | No known adverse effects on fertility in either males or females. Iodinated contrast agents are not associated with reproductive toxicity. Fertility impairment is unlikely. |