OSMOVIST 190
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OSMOVIST 190 (OSMOVIST 190).
Iodinated contrast media with high osmolality, providing radiographic contrast by attenuating X-rays, primarily due to iodine content.
| Metabolism | Not metabolized; excreted unchanged by glomerular filtration. |
| Excretion | Primarily renal (glomerular filtration). Excreted unchanged in urine, with less than 2% biliary/fecal excretion. |
| Half-life | Terminal elimination half-life approximately 110 minutes. In renal impairment, half-life is prolonged, requiring dose adjustment. |
| Protein binding | Negligible protein binding; less than 1% bound to plasma proteins. |
| Volume of Distribution | Approximately 0.28 L/kg, indicating distribution primarily in extracellular fluid. |
| Bioavailability | Intravenous route provides 100% bioavailability; non-IV routes (e.g., oral) not applicable or negligible. |
| Onset of Action | Immediate onset following IV or intra-arterial injection due to reaching contrast enhancement within seconds. |
| Duration of Action | Duration of contrast enhancement is brief, typically minutes, due to rapid distribution and elimination. |
Intravenous administration of 0.1-0.3 mL/kg (0.19-0.57 mg iodine/kg) for adults; may repeat as needed. Maximum total dose 1.5 mL/kg.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR <30 mL/min/1.73 m²: use lowest effective dose, ensure adequate hydration, consider postponing procedure; eGFR <15: generally contraindicated unless necessary. |
| Liver impairment | No specific dose adjustment for Child-Pugh class; use lowest effective dose in severe impairment due to potential for altered contrast clearance. |
| Pediatric use | 0.1-0.2 mL/kg intravenous, not to exceed 1.5 mL/kg total; individualize based on patient size and procedure. |
| Geriatric use | Use lowest effective dose; assess renal function (e.g., eGFR) prior to administration; ensure adequate hydration; increased risk of contrast-induced nephropathy. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OSMOVIST 190 (OSMOVIST 190).
| Breastfeeding | Iodinated contrast is excreted into breast milk in small amounts (M/P ratio <1). The estimated infant dose is <1% of maternal dose, considered clinically insignificant. Breastfeeding can continue without interruption; however, some guidelines recommend discarding milk for 12-24 hours post-procedure. |
| Teratogenic Risk | Iodinated contrast agents cross the placenta. First trimester exposure is associated with a theoretical risk of fetal thyroid suppression, but no definitive teratogenic effects have been established in humans. Second and third trimester exposure may cause transient neonatal hypothyroidism. The risk is low with single exposure. |
■ FDA Black Box Warning
Risk of serious adverse reactions including anaphylaxis, renal failure, and cardiovascular complications, especially in patients with history of allergy, asthma, or renal impairment.
| Serious Effects |
["Absolute: Known hypersensitivity to ioversol or any component, previous life-threatening reaction to iodinated contrast media.","Relative: Severe renal impairment (eGFR <30 mL/min), unstable cardiovascular status, pregnancy, and lactation."]
| Precautions | ["Risk of contrast-induced nephropathy (CIN) in patients with pre-existing renal impairment, diabetes, dehydration, or concurrent nephrotoxic drugs.","Hypersensitivity reactions including anaphylaxis; premedication recommended in high-risk patients.","Severe cardiovascular effects including cardiac arrest, arrhythmias, and hypotension.","Electrolyte disturbances and fluid overload in patients with heart failure."] |
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| Fetal Monitoring | Monitor maternal renal function (serum creatinine), thyroid function (TSH) in neonates after exposure. Assess for signs of allergic reaction or contrast-induced nephropathy. Fetal monitoring not routinely required, but neonatal thyroid screening is recommended if exposure occurred in the third trimester. |
| Fertility Effects | No known effects on human fertility. Animal studies have not shown reproductive toxicity at clinical doses. |