Olanzapine oral tablets (single agent) - selected U.S. label sections
- Product / population
- Selected U.S. single-agent olanzapine oral tablet label. Not LYBALVI or a long-acting injectable.
- Renal measure
- Qualitative degree of renal impairment in PK section
Selected renal sections only, not a complete monograph. Exact product, indication, patient population, renal method and all other contraindications/interactions remain controlling.
Second independent renal reference and clinician adjudication remain pending; no all-indication, dialysis or pediatric dose may be inferred from an omitted field.
Renal and dialysis comments
Renal dysfunction alone does not require olanzapine dose adjustment. Pharmacokinetics were similar in severe impairment and normal renal function. Olanzapine is not removed by dialysis; renal effects on metabolite elimination have not been studied.
Combination-product distinction
Do not apply this single-agent statement to olanzapine/samidorphan; that combination has a separate ESRD restriction.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e8626e68-088d-47ff-bf06-489a778815aa