RENOGRAFIN-76
Clinical safety rating: caution
Comprehensive clinical and safety monograph for RENOGRAFIN-76 (RENOGRAFIN-76).
Radiopaque contrast agent that attenuates X-rays by absorbing them due to its high iodine content, allowing visualization of vascular structures and organs during radiographic procedures.
| Metabolism | Not metabolized; excreted unchanged via glomerular filtration. |
| Excretion | Renal: >95% unchanged via glomerular filtration; biliary/fecal: negligible (<5%) |
| Half-life | Terminal elimination half-life: 1–2 hours (normal renal function); prolonged to >20 hours in severe renal impairment (CrCl <10 mL/min) |
| Protein binding | Low (<10%), primarily to albumin; negligible binding to other proteins |
| Volume of Distribution | 0.2–0.3 L/kg; confined to extracellular fluid, minimal intracellular penetration |
| Bioavailability | Oral: <1% (due to poor absorption and first-pass effect); Intravenous: 100% |
| Onset of Action | Intravenous: immediate (within seconds) for contrast enhancement; oral: 15–30 minutes for GI opacification |
| Duration of Action | Intravenous: 15–30 minutes for diagnostic imaging; oral: 30–60 minutes for GI studies; duration increases with renal impairment |
Intravenous administration of 50-100 mL (14.1-28.2 g iodine) as a single dose for angiography; dose varies by procedure and patient size.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR <30 mL/min: contraindicated due to risk of contrast-induced nephropathy; eGFR 30-60: use lowest effective dose, ensure hydration; eGFR >60: no adjustment. |
| Liver impairment | No specific adjustments for hepatic impairment; use caution in severe hepatic dysfunction due to potential coagulation abnormalities. |
| Pediatric use | 0.5-2.0 mL/kg (141-564 mg iodine/kg) intravenously, not to exceed adult dose; individualize based on age, weight, and procedure. |
| Geriatric use | Use lowest effective dose; ensure adequate hydration; monitor renal function as age-related decline increases risk of nephrotoxicity. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for RENOGRAFIN-76 (RENOGRAFIN-76).
| Breastfeeding | Excreted into breast milk in small amounts (<1% of maternal dose). M/P ratio not established. Oral bioavailability in infant negligible. American College of Radiology considers contrast administration compatible with breastfeeding; no need to interrupt breastfeeding. Advise discarding milk for 24 hours if mother is concerned. |
| Teratogenic Risk | RENOGRAFIN-76 is an iodinated contrast agent. Teratogenic risk: a) First trimester: No known increased risk of major malformations from clinical data; however, theoretical risk from free iodide causing fetal thyroid suppression with high doses or prolonged exposure. b) Second and third trimesters: Potential fetal hypothyroidism from iodide exposure; risk decreases with gestational age. Neonatal thyroid function screening recommended after in utero exposure. |
■ FDA Black Box Warning
Not for intrathecal use; severe adverse reactions including convulsions and death have occurred following inadvertent intrathecal administration.
| Serious Effects |
["History of severe hypersensitivity reaction to ioxitalamate or any component of the formulation","Intrathecal administration","Anuria or severe renal impairment"]
| Precautions | ["Risk of contrast-induced nephropathy, particularly in patients with pre-existing renal impairment, diabetes mellitus, or dehydration","Anaphylactic and anaphylactoid reactions, including fatal reactions, may occur regardless of history; pretreatment may be considered for high-risk patients","Severe cutaneous adverse reactions such as Stevens-Johnson syndrome have been reported","Thyroid storm may be induced in patients with hyperthyroidism or thyroid nodules","Use with caution in patients with heart failure, coronary artery disease, or pheochromocytoma"] |
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| Fetal Monitoring | Monitor maternal vital signs before, during, and after procedure. Fetal heart rate monitoring during second/third trimester if indicated. Neonatal thyroid function test (TSH, T4) at 1-2 weeks of age if high dose or repeated exposure. Assess maternal renal function as contrast may worsen pregnancy-related renal impairment. |
| Fertility Effects | No known direct effects on fertility. In animal studies, no impairment of fertility at clinically relevant doses. Used only during pregnancy for medical necessity; no evidence of long-term reproductive toxicity. |