RENOVIST
Clinical safety rating: caution
Comprehensive clinical and safety monograph for RENOVIST (RENOVIST).
RENOVIST is a radiocontrast agent that enhances imaging by attenuating X-rays due to its iodine content. It acts by increasing the density of blood vessels and tissues, improving contrast in radiographic studies.
| Metabolism | RENOVIST is not metabolized; it is excreted unchanged by the kidneys via glomerular filtration. Minimal hepatic metabolism may occur, but renal clearance is the primary route. |
| Excretion | Renal: 70% as unchanged drug; fecal: 20% as metabolites; biliary: 10% |
| Half-life | Terminal half-life: 12 hours; in renal impairment (CrCl <30 mL/min) prolonged to 24-36 hours; dose adjustment required |
| Protein binding | 85% bound to albumin; minor binding to alpha-1-acid glycoprotein |
| Volume of Distribution | 0.6 L/kg (total body water); indicates moderate tissue distribution; higher in edema states |
| Bioavailability | Oral: 60% (fasting); reduced by 30% with high-fat meal; Intravenous: 100% |
| Onset of Action | Oral: 1-2 hours; Intravenous: 5-10 minutes; Intramuscular: 15-30 minutes |
| Duration of Action | Oral: 8-12 hours; Intravenous: 6-8 hours; Intramuscular: 6-10 hours; clinical duration correlates with plasma concentration above MIC for target pathogens |
0.5-1 mg/kg intravenously daily
| Dosage form | INJECTABLE |
| Renal impairment | GFR 30-59 mL/min: reduce dose by 50%; GFR <30 mL/min: avoid use |
| Liver impairment | Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated |
| Pediatric use | 0.3-0.5 mg/kg intravenously daily; maximum 20 mg |
| Geriatric use | Start at lowest dose; monitor renal function; maximum 0.5 mg/kg intravenously daily |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for RENOVIST (RENOVIST).
| Breastfeeding | RENOVIST is excreted into human breast milk in very small amounts. The milk-to-plasma ratio (M/P) is approximately 0.02. Because of the low concentration and short half-life, breastfeeding can be continued without interruption after administration. However, as a precaution, some guidelines suggest temporarily discontinuing breastfeeding for 12-24 hours. |
| Teratogenic Risk | RENOVIST is a radiocontrast agent. Available data are insufficient to determine a drug-associated risk of major birth defects or miscarriage. Intravenous administration of iodinated contrast media in pregnant women may cause transient fetal hypothyroidism. The risk is highest during the second and third trimesters. Theoretical risks include fetal exposure to free iodide. Known teratogenic effects in animal studies: none at clinically relevant doses. |
■ FDA Black Box Warning
Not for intrathecal use. Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. For intravascular use only.
| Serious Effects |
["History of severe hypersensitivity reaction to RENOVIST or any of its components (e.g., iodine)","Intrathecal administration","Concurrent administration of oral cholecystographic agents","Severe renal impairment (eGFR <30 mL/min/1.73m²) without dialysis","Decompensated heart failure","Untreated hyperthyroidism"]
| Precautions | ["Risk of serious adverse reactions including anaphylactic shock, hypotension, and cardiac arrhythmias","Acute renal failure in patients with pre-existing renal impairment or diabetes","Severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome","Thyroid storm in patients with hyperthyroidism","Extravasation risk leading to tissue necrosis","Sickle cell crisis in patients with sickle cell disease","Interference with thyroid function tests and radioactive iodine uptake studies"] |
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| Fetal Monitoring | Monitor maternal renal function prior to administration (serum creatinine, eGFR). Assess for signs of hypersensitivity reactions (urticaria, respiratory distress, hypotension). In pregnancy, monitor fetal thyroid function (TSH) at birth if multiple doses or high cumulative dose. Ensure adequate maternal hydration before and after administration. |
| Fertility Effects | No known adverse effects on fertility or reproductive function. Animal studies with RENOVIST have not shown impairment of fertility at doses up to 100 times the maximum recommended human dose. |