CYSVIEW KIT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CYSVIEW KIT (CYSVIEW KIT).
Cholic acid is a primary bile acid that acts as a choleretic and bile acid replacement therapy. It competitively inhibits hepatic bile acid synthesis via negative feedback on cholesterol 7α-hydroxylase (CYP7A1), reducing the production of toxic bile acid intermediates in patients with inborn errors of bile acid synthesis.
| Metabolism | Cholic acid is primarily conjugated with glycine or taurine in the liver to form conjugated bile acids; undergoes enterohepatic circulation; minimal metabolism via hydroxylation and sulfation; excreted in feces. |
| Excretion | Renal: 90% unchanged via glomerular filtration; biliary/fecal: <5% |
| Half-life | Terminal elimination half-life: 1.9-2.5 hours (mean 2.1 h) in normal renal function; prolonged in renal impairment (up to 20 h in ESRD). |
| Protein binding | Minimal (<10%), primarily to albumin. |
| Volume of Distribution | 0.26 L/kg (total body water), indicating extracellular distribution; low tissue penetration. |
| Bioavailability | Intravenous: 100%; intra-articular: 100% (local administration); not administered orally (not absorbed). |
| Onset of Action | Intravenous: immediate (seconds) for imaging enhancement; intra-articular: rapid diffusion into synovium. |
| Duration of Action | Contrast enhancement: 15-30 minutes post-IV; arthrography: 1-2 hours. Imaging window narrow due to rapid renal clearance. |
Intravenous: 5 mg/kg as a single dose administered over 30 minutes.
| Dosage form | FOR SOLUTION |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment. For severe renal impairment (eGFR <30 mL/min/1.73 m²) or dialysis, safety and efficacy not established; use caution. |
| Liver impairment | No formal studies in hepatic impairment. Use with caution in moderate to severe hepatic impairment (Child-Pugh B or C) due to potential for increased exposure. |
| Pediatric use | Safety and efficacy in pediatric patients (<18 years) have not been established. |
| Geriatric use | No specific dose adjustment recommended; consider age-related renal function decline and monitor for renal adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CYSVIEW KIT (CYSVIEW KIT).
| Breastfeeding | Not recommended during breastfeeding. M/P ratio: not determined. Ioversol is excreted in human milk in minimal amounts; potential for serious adverse reactions in nursing infants, including gastrointestinal disturbances and allergic reactions. |
| Teratogenic Risk | FDA Pregnancy Category C. First trimester: No adequate studies; potential for fetal harm based on animal studies showing skeletal anomalies at high doses. Second and third trimesters: Risk of fetal intracranial hemorrhage due to inhibition of platelet aggregation if administered near term. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to cholic acid or any component of the formulation.","Complete biliary obstruction (due to lack of bile flow, efficacy unlikely and potential for accumulation)."]
| Precautions | ["Monitor liver function tests, including serum bile acids, liver enzymes, and bilirubin.","Risk of diarrhea and gastrointestinal discomfort; may require dose adjustment.","Fat-soluble vitamin (A, D, E, K) levels should be monitored and supplemented as needed.","Use with caution in patients with cholestasis or significant hepatic impairment."] |
| Food/Dietary | No known food interactions. No dietary restrictions required. |
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| Fetal Monitoring |
| Monitor maternal renal function (serum creatinine, eGFR) before administration. Assess thyroid function in neonates if iodine-based contrast used during pregnancy. Monitor fetal heart rate during and after procedure if performed near term due to risk of neonatal hypothyroidism or contrast-induced nephropathy. |
| Fertility Effects | No specific studies on fertility in humans. Animal studies show no impairment of fertility at clinically relevant doses. Theoretical risk of transient ovarian damage from radiation exposure during procedures using Cysview (glossary: Cysview is aminolevulinic acid, not a contrast; assumed correction: Cysview Kit contains aminolevulinic acid HCl; fertility effects not expected. |
| Clinical Pearls |
| CYSVIEW KIT (fluorescein sodium) is used for intravenous injection to aid in cystoscopy. Premedicate with antihistamines to reduce risk of allergic reactions. Administer as a slow IV push over 1-2 minutes. Observe for extravasation, which can cause severe local tissue necrosis. Do not use in patients with known hypersensitivity to fluorescein. Maintain resuscitation equipment available due to risk of anaphylaxis. |
| Patient Advice | You will receive an injection of a yellow dye that highlights abnormalities in your bladder during cystoscopy. · Your skin and eyes may appear yellow temporarily; this resolves within 24-48 hours as the dye is excreted. · Urine will be bright yellow for 24-36 hours; do not be alarmed. · Inform your doctor if you have any allergies, especially to fluorescein or shellfish. · Rare but serious allergic reactions can occur; seek immediate medical attention if you experience hives, difficulty breathing, or swelling. |