Can vonaprazan be given to patients with end-stage Chronic Kidney Disease (CKD)?

Vonaprazan Use in End-Stage Chronic Kidney Disease

Vonaprazan can be administered to patients with end-stage chronic kidney disease (CKD), but dose adjustment may be necessary due to increased drug exposure in severe renal impairment. 1

Pharmacokinetics in Renal Impairment

• According to the FDA label, vonaprazan exposure (AUC∞) is 2.4 times greater in patients with severe renal impairment compared to those with normal renal function 1
• In dialysis-dependent patients, AUC∞ estimates were 1.3-fold greater compared to subjects with normal renal function 1
• Vonaprazan is present in dialysate but represents only 0.94% of the administered dose, indicating minimal removal by dialysis 1

Dosing Recommendations

• The FDA label indicates that dose adjustment may be necessary for patients with severe renal impairment or those requiring dialysis 1
• Unlike many medications that require significant dose adjustments in CKD, proton pump inhibitors (PPIs) as a class generally do not require major dose adjustments based on CKD stage or glomerular filtration rate 2
• For patients with end-stage renal disease, individualized dosing decisions should be made based on the patient's specific clinical situation 1

Clinical Considerations

• When prescribing medications to patients with end-stage CKD, it's important to consider potential drug interactions, particularly with medications that have narrow therapeutic windows 2
• PPIs are commonly prescribed to CKD patients, particularly for gastroprotection when using antiplatelet therapy 2
• For CKD patients receiving antiplatelet therapy, PPI co-administration is recommended to reduce gastrointestinal bleeding risk 2

Monitoring Recommendations

• Regular monitoring of renal function is advisable when using medications in patients with end-stage CKD 3
• Be vigilant for potential adverse effects that may be exacerbated by reduced drug clearance in end-stage CKD 3
• Drug dosing errors are common in patients with renal impairment and can cause adverse effects and poor outcomes, so careful attention to dosing is essential 3

Important Caveats

• Protein binding of vonaprazan is not affected by impaired renal function, which is an important consideration in drug dosing for end-stage CKD patients 1
• When prescribing any medication to patients with end-stage CKD, the risk-benefit ratio should be carefully evaluated, as these patients often have multiple comorbidities and complex medication regimens 3
• While vonaprazan can be used in end-stage CKD, it's important to note that the FDA label specifically mentions the increased drug exposure in this population, suggesting caution is warranted 1