Gemtessa (Vibegron) Dosing in Renal Impairment
No dosage adjustment of Gemtessa is required for patients with mild, moderate, or severe renal impairment (eGFR 15 to <90 mL/min/1.73 m²), but it is not recommended for patients with eGFR <15 mL/min/1.73 m² or those on hemodialysis. 1
Standard Dosing Across Renal Function Levels
For patients with eGFR ≥15 mL/min/1.73 m²: The standard dose of Gemtessa (vibegron) 75 mg once daily can be administered without any adjustment, regardless of whether renal impairment is classified as mild (eGFR 60-89), moderate (eGFR 30-59), or severe (eGFR 15-29). 1
For patients with eGFR <15 mL/min/1.73 m²: Gemtessa has not been studied in this population and is not recommended, including patients requiring hemodialysis. 1
Clinical Rationale
The lack of required dose adjustment across a wide range of renal function (eGFR 15-90 mL/min/1.73 m²) reflects vibegron's pharmacokinetic profile, which does not result in clinically significant drug accumulation even in severe renal impairment. 1
Important Caveats
Do not confuse Gemtessa (vibegron) with gemcitabine: The question asks about "Gemtessa," which is the brand name for vibegron, a beta-3 adrenergic agonist used for overactive bladder. This is completely different from gemcitabine, a chemotherapy agent used in pancreatic cancer. 1, 2, 3, 4
Hepatic impairment considerations: While not part of the renal dosing question, note that no dose adjustment is needed for mild to moderate hepatic impairment (Child-Pugh A and B), but Gemtessa is not recommended for severe hepatic impairment (Child-Pugh C). 1
Monitoring Recommendations
No specific renal function monitoring requirements are mandated by the FDA label for patients with eGFR ≥15 mL/min/1.73 m², though routine clinical assessment remains appropriate. 1