From the FDA Drug Label
Severe Renal Impairment Avoid use in patients with severe renal impairment, GFR <30 mL/minute. Increased plasma concentration of duloxetine delayed-release capsules, and especially of its metabolites, occurred in patients with end-stage renal disease (requiring dialysis) Limited data are available on the effects of duloxetine delayed-release capsules in patients with end-stage renal disease (ESRD). After a single 60 mg dose of duloxetine delayed-release capsules, C max and AUC values were approximately 100% greater in patients with ESRD receiving chronic intermittent hemodialysis than in subjects with normal renal function
Duloxetine is not recommended for use in patients with severe renal impairment, including those requiring dialysis, due to increased plasma concentrations and potential adverse effects 1 1.
From the Research
Duloxetine should be used with caution in dialysis patients, and generally is not recommended for those with severe renal impairment (creatinine clearance <30 mL/min) or end-stage renal disease. The medication is not significantly removed by hemodialysis, which means it can accumulate in the body of dialysis patients, potentially leading to increased side effects 2. If duloxetine must be used in a dialysis patient, a reduced dose should be considered, typically starting at 30 mg once daily rather than the usual 60 mg daily dose, with careful monitoring for adverse effects such as nausea, dizziness, somnolence, and increased blood pressure.
Some key points to consider when using duloxetine in dialysis patients include:
- The concern with duloxetine in renal impairment stems from altered drug metabolism and elimination, as approximately 70% of duloxetine is normally excreted in urine as metabolites 2.
- Alternative antidepressants with less renal elimination, such as sertraline or mirtazapine, may be safer options for dialysis patients requiring treatment for depression or neuropathic pain 3, 4.
- The use of sertraline in hemodialysis patients has been studied, and it appears to be relatively safe and efficient in this population, although careful consideration of benefits and possible side effects is necessary 4.
- A systematic review of antidepressants in patients with CKD3-5 found that dose reduction is necessary for several antidepressants, including selegiline, amitriptylinoxide, venlafaxine, desvenlafaxine, milnacipran, bupropion, reboxetine, and tianeptine 5.
Overall, the use of duloxetine in dialysis patients requires careful consideration of the potential risks and benefits, and alternative treatments may be preferred in many cases.