Drug Interactions between Urin D/S and voclosporin

MONITOR CLOSELY: The following interaction applies only to products containing sodium biphosphate that are used for bowel cleansing. It does not apply to products containing sodium biphosphate that are used for other, non-laxative related purposes.

Coadministration with agents that affect renal function or perfusion such as diuretics, ACE inhibitors, angiotensin receptor blockers, and nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of acute phosphate nephropathy associated with the use of bowel-cleansing phosphate solutions. The risk and/or severity of fluid and electrolyte disturbances may also be increased, which can lead to serious adverse events including cardiac arrhythmias, seizures, and renal impairment. Acute phosphate nephropathy is a rare adverse event that presents as acute renal failure with minimal proteinuria and a bland urine sediment. Renal biopsy findings are consistent with nephrocalcinosis and include acute and/or chronic renal tubular injury, calcium-phosphate crystal deposition in the distal tubules and collecting ducts, and no other pattern of histological injury. The risk of acute phosphate nephropathy stems from the large phosphate load, fluid shifts, and decreased intravascular volume, which can be exacerbated in the presence of medications that affect renal perfusion or function. In reported cases, acute renal failure was typically diagnosed within two to five months of colonoscopy. These cases often resulted in permanent impairment of renal function, some requiring long-term dialysis.

MANAGEMENT: Caution is advised when bowel-cleansing phosphate preparations are prescribed in patients treated with agents that affect renal function or perfusion, particularly if they are frail or elderly. Bowel-cleansing phosphate preparations should not be used in patients who have impaired renal function or perfusion, dehydration, or uncorrected electrolyte abnormalities. In patients at risk for acute phosphate nephropathy, baseline and postprocedure labs including serum electrolytes, calcium, phosphate, BUN, and creatinine should be performed. Patients should be advised not to exceed the recommended dosage of their bowel-cleansing preparation and to drink sufficient quantities of clear fluids during before, during, and after bowel cleansing. Limited data suggest that administration of an electrolyte rehydration solution may attenuate the electrolyte abnormalities and hypovolemia. Hospitalization and intravenous fluid hydration may be appropriate for frail or elderly patients who may be unable to drink an adequate volume of fluid.

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MONITOR: The following interaction applies only to products containing sodium biphosphate that are used for bowel cleansing. It does not apply to products containing sodium biphosphate that are used for other, non-laxative related purposes.

The use of bowel cleansing preparations may increase the risk of ventricular arrhythmia, particularly torsade de pointes, in patients treated with drugs that prolong the QT interval. Severe and potentially fatal cases of electrolyte disorders and arrhythmias have been reported in elderly patients using bowel cleansing products. Electrolyte disturbances including hypokalemia and hypomagnesemia are known risk factors for torsade de pointes associated with QT interval prolongation.

MANAGEMENT: Caution is advised when bowel cleansing preparations are prescribed in patients treated with drugs that prolong the QT interval. Monitoring of baseline and posttreatment serum electrolyte levels is recommended, particularly in the elderly. Patients should be instructed to drink plenty of clear liquids before, during, and after the bowel preparation process. Consideration should be given to consumption of 36 to 48 fluid ounces of a carbohydrate-electrolyte solution in the six hours before the first dose. Patients should be advised to seek prompt medical attention if they experience symptoms that could indicate the occurrence of torsade de pointes such as dizziness, lightheadedness, fainting, palpitation, irregular heart rhythm, shortness of breath, or syncope.

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MONITOR: Coadministration of the calcineurin inhibitor voclosporin with other nephrotoxic agents may increase the risk of acute and/or chronic nephrotoxicity due to additive effects on the kidney. Decreased glomerular filtration rate was the most commonly reported adverse effect in the phase 2 and 3 clinical studies in patients with lupus nephritis, reported in 70 patients treated with voclosporin 23.7 mg twice daily and 27 patients treated with 39.5 mg twice daily, compared to 25 patients in the placebo group. Of the patients with reduced rates in the voclosporin 23.7 mg twice daily group, reductions primarily occurred within the first 3 months of treatment (71%) and the majority resolved or improved with dose modification (78%). However, permanent voclosporin treatment discontinuation was required in 14% (10/70) of the patients in the 23.7 mg twice daily group, with glomerular filtration rate recovering in 40% (4/10) of these patients within 3 months of treatment discontinuation. Serious renal adverse reactions were reported in 13 patients and 9 patients in the voclosporin 23.7 mg twice daily and placebo groups, respectively. The most commonly reported serious renal adverse reactions were acute kidney injury and renal impairment. The risk of nephrotoxicity may increase with increased plasma levels of voclosporin, treatment duration beyond one year, or concomitant use with other drugs associated with nephrotoxicity.

MANAGEMENT: Caution is advised if voclosporin is used in patients who have recently received or are receiving treatment with potentially nephrotoxic drugs. Estimated glomerular filtration rate (eGFR) should be monitored every two weeks for the first month and at least every 4 weeks thereafter, with the dose adjusted as per the manufacturer's product labeling. Persistent reduction in eGFR should be evaluated for chronic calcineurin inhibitor-related nephrotoxicity. Due to the increased risk of acute and/or chronic nephrotoxicity, voclosporin should not be administered to patients whose baseline eGFR is below 45 mL/min/min/1.73 m2 unless the benefit exceeds the risk.

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