From the FDA Drug Label
8.6 Renal Impairment Clinical experience with quetiapine in patients with renal impairment is limited [see Clinical Pharmacology (12.3)]. The FDA drug label does not answer the question.
From the Research
Quetiapine (quetiapine fumarate) generally does not require dose adjustment in patients with renal impairment. The standard dosing regimen can be used in patients with reduced kidney function, including those with severe renal impairment. This is because quetiapine is primarily metabolized by the liver, with approximately 73% of the drug eliminated through hepatic metabolism, as noted in the study by 1. Only about 20% of quetiapine and its metabolites are excreted by the kidneys, which explains why renal function has minimal impact on the drug's clearance.
Key Points to Consider
- Quetiapine's pharmacokinetics are not significantly altered by renal impairment, as shown in the study by 2.
- The primary route of elimination is through hepatic metabolism, with a mean terminal half-life of approximately 7 hours, as reported in the study by 1.
- While formal dose adjustments are not required for patients with renal impairment, it is still advisable to monitor these patients more closely for side effects, especially elderly patients who may have age-related decreases in both renal and hepatic function.
- Some clinicians may consider starting at lower doses and titrating more gradually in patients with severe renal impairment as a precautionary measure, though this is not mandated in official prescribing information, as discussed in the study by 3.
- The primary clinical concern with quetiapine dosing should be directed toward hepatic impairment, where dose adjustments are specifically recommended, as noted in the study by 2.
Clinical Implications
- The study by 4 highlights the importance of considering the risk of acute kidney injury and other adverse outcomes in older adults taking atypical antipsychotic drugs, including quetiapine.
- The study by 5 provides a comprehensive review of the metabolic and excretory pathways of atypical antipsychotics, including quetiapine, and emphasizes the importance of understanding these pathways in special populations, such as those with comorbid conditions or pharmacogenetic variability.
- The most recent study by 3 emphasizes the need for individualized dosing of antipsychotics, including quetiapine, and highlights the importance of monitoring plasma levels in clinical practice.