RENOVUE-65
Clinical safety rating: caution
Comprehensive clinical and safety monograph for RENOVUE-65 (RENOVUE-65).
Iothalamate meglumine is an ionic, high-osmolality iodinated contrast agent that attenuates X-rays, enhancing vascular and tissue contrast. It acts by increasing the radiopacity of blood vessels and organs during imaging.
| Metabolism | Not metabolized; excreted unchanged via glomerular filtration in the kidneys. |
| Excretion | Renal: 100% as unchanged drug; no biliary or fecal elimination. |
| Half-life | Terminal elimination half-life: 2.0 hours in patients with normal renal function; prolonged to >24 hours in severe renal impairment (CrCl <10 mL/min). |
| Protein binding | Minimal (<5%); primarily binds to serum albumin. |
| Volume of Distribution | 0.3 L/kg; distributes primarily in extracellular fluid, does not cross intact blood-brain barrier. |
| Bioavailability | Not applicable for intravenous use; oral bioavailability is negligible as the drug is not administered orally. |
| Onset of Action | Intravenous: immediate (within seconds); intra-arterial: within 1-2 minutes. |
| Duration of Action | Radiographic effect persists for 10-30 minutes post-injection; contrast enhancement declines rapidly due to renal excretion. |
Intravenous injection, 10 mL (6.48 g iobitridol) as a single dose. Repeat dosing: up to 3 additional doses within 30 minutes, maximum 40 mL per procedure.
| Dosage form | INJECTABLE |
| Renal impairment | GFR 30–59 mL/min: reduce to 50% of standard dose. GFR <30 mL/min: contraindicated or use extreme caution with minimal dose (e.g., 5 mL). |
| Liver impairment | Child-Pugh Class B: reduce dose by 25%. Child-Pugh Class C: contraindicated (risk of nephrotoxicity and hypersensitivity). |
| Pediatric use | Weight-based: 2 mL/kg (1.3 g iobitridol/kg) IV, maximum 10 mL per dose. May repeat once if needed. |
| Geriatric use | Reduce dose by 25% due to age-related renal impairment; consider GFR-based adjustment; monitor for adverse reactions. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for RENOVUE-65 (RENOVUE-65).
| Breastfeeding | Contraindicated due to risk of infant renal toxicity; M/P ratio not available as drug is not recommended during breastfeeding. |
| Teratogenic Risk | First trimester: Renal agenesis and dysgenesis reported based on animal studies; second and third trimesters: Oligohydramnios, fetal renal impairment, skull ossification defects, and neonatal anuria/hypotension. |
| Fetal Monitoring |
■ FDA Black Box Warning
Risk of fatal hypersensitivity reactions, anaphylaxis, and contrast-induced nephropathy. Serious adverse events including cardiopulmonary arrest and death have been reported.
| Serious Effects |
Known hypersensitivity to iothalamate or any component, anuria, severe oliguria, and concurrent administration of biguanides (metformin) without renal function monitoring.
| Precautions | Risk of hypersensitivity reactions; premedicate high-risk patients. Caution in renal impairment, diabetes, multiple myeloma, and dehydration. Monitor renal function post-procedure. Avoid extravasation; can cause tissue necrosis. |
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| Serial fetal ultrasound for renal function and amniotic fluid volume; maternal blood pressure and renal function monitoring. |
| Fertility Effects | No human data; animal studies show reduced fertility at high doses due to renal toxicity. |