Pharmacokinetics only
Renal measure Indexed creatinine clearance, mL/min/1.73 m2 Renal action or finding A small PK comparison found similar donepezil clearance in 11 patients with CrCl <18 mL/min/1.73 m2 and 11 matched controls. Limits and monitoring This finding does not establish a hemodialysis dose or timing rule.
Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 33, effective 2021-12-30; posted Jun 30, 2026 | Selected sections checked 2026-11-07. Independent clinical review pending.
No adjustment within stated limits
Renal measure Clinical renal category or population named in the cited section Renal action or finding Mild, moderate and severe renal impairment require no dose change. Limits and monitoring ESRD was inadequately studied and dialysis patients were not studied. This guidance applies to single-ingredient doravirine.
Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 21, effective 2026-07-08; posted Jul 13, 2026 | Selected sections checked 2026-11-07. Independent clinical review pending.
Restriction or avoidance
Renal measure Creatinine clearance (CrCl), mL/min; use the product-specific calculation Renal action or finding Below estimated CrCl 50 mL/min, the fixed-dose tablet is not recommended because the lamivudine and TDF doses cannot be lowered individually. Limits and monitoring Verify all three ingredients. Doravirine alone has different renal guidance.
Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 24, effective 2026-07-08; posted Jul 13, 2026 | Selected sections checked 2026-11-07. Independent clinical review pending.
Restriction or avoidance
This summary uses the identified dated label. Verify the current label for this presentation before applying the regimen.
Renal measure GFR, mL/min as printed in the dosage instruction Renal action or finding Avoid use when GFR is below 30 mL/min. Limits and monitoring Exposure rises in ESRD. The GFR threshold is printed in mL/min in the dosage instruction.
Review 1 product or source caution
Verify the current prescribing information for this presentation.
DailyMed SPL version 3, effective 2016-08-06; posted Aug 08, 2016 | Selected sections checked 2026-11-07. Independent clinical review pending.
Restriction or avoidance
This summary uses the identified dated label. Verify the current label for this presentation before applying the regimen.
Renal measure Creatinine clearance (CrCl), mL/min; use the product-specific calculation Renal action or finding Below CrCl 50 mL/min, the fixed combination is not recommended. Its components cannot be adjusted individually in this tablet. Limits and monitoring Check all three agents. The renal rules for tenofovir alafenamide products differ.
Review 1 product or source caution
Verify the current prescribing information for this presentation.
DailyMed SPL version 3, effective 2013-05-03; posted May 06, 2013 | Selected sections checked 2026-11-07. Independent clinical review pending.
No adjustment within stated limits
Renal measure Creatinine clearance (CrCl), mL/min; use the product-specific calculation Renal action or finding At CrCl 30 to below 90 mL/min, retain the indicated dose. Below 30, a dose has not been established. Limits and monitoring Review the companion oncology agents individually.
Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 23, effective 2026-02-26; posted Mar 02, 2026 | Selected sections checked 2026-11-07. Independent clinical review pending.
Pharmacokinetics only
Renal measure Indexed GFR/eGFR, mL/min/1.73 m2 Renal action or finding At eGFR 30-89 mL/min/1.73 m2, the label reports no clinically meaningful difference in exposure. Limits and monitoring Data in severe impairment are limited; PK during dialysis is unknown. These findings do not define a dialysis dose.
Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 14, effective 2025-10-24; posted Nov 17, 2025 | Selected sections checked 2026-11-07. Independent clinical review pending.
Restriction or avoidance
This summary uses the identified dated label. Verify the current label for this presentation before applying the regimen.
Renal measure Indexed GFR/eGFR, mL/min/1.73 m2 Renal action or finding Use is not recommended below eGFR 45 or in end-stage renal disease. Monitor patients with mild impairment for effects that can cause hypovolemia. Limits and monitoring Verify the presentation and source date. In renal transplant recipients, monitor closely for adverse effects that deplete volume.
Review 1 product or source caution
This presentation has a 2024 FDA label. The 2018 FDA document for the product used different renal wording. Check the product presentation and label date.
Prescribing information revised 11/2024 | Selected sections checked 2026-11-07. Independent clinical review pending.
No adjustment within stated limits
Renal measure Clinical renal category or population named in the cited section Renal action or finding No renal dose adjustment is needed for ezetimibe. Limits and monitoring If used with another lipid-lowering drug, verify that drug's dose and renal precautions separately.
Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 8, effective 2025-11-25; posted Nov 26, 2025 | Selected sections checked 2026-11-07. Independent clinical review pending.
Dose or interval change
This summary uses the identified dated label. Verify the current label for this presentation before applying the regimen.
Renal measure Cockcroft-Gault creatinine clearance, mL/min Renal action or finding For adult intermittent hemodialysis (HD), induction must not exceed 1.25 mg/kg IV after HD three times weekly. Maintenance must not exceed 0.625 mg/kg IV after HD three times weekly. At CrCl 50-69, induction is 2.5 mg/kg every 12 hours and maintenance 2.5 mg/kg daily; at 25-49, use 2.5 and 1.25 mg/kg daily, respectively; at 10-24, use 1.25 and 0.625 mg/kg daily. Limits and monitoring Infuse over one hour. Check CrCl and blood counts. The label's nondialysis table separates induction from maintenance; dosing below CrCl 10 without HD is not supplied by the HD row.
Review 1 product or source caution
Verify the current prescribing information for this presentation.
Prescribing information revised 07/2017 | Selected sections checked 2026-11-07. Independent clinical review pending.
No adjustment within stated limits
Renal measure Clinical renal category or population named in the cited section Renal action or finding Renal impairment requires no dose adjustment, including in dialysis patients. Limits and monitoring Treatment duration depends on HCV and transplant history. Check hepatic eligibility and interactions separately.
Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 201, effective 2025-06-25; posted Aug 07, 2026 | Selected sections checked 2026-11-07. Independent clinical review pending.
Restriction or avoidance
This summary uses the identified dated label. Verify the current label for this presentation before applying the regimen.
Renal measure Creatinine clearance (CrCl), mL/min; use the product-specific calculation Renal action or finding Do not administer IV Boniva when CrCl is below 30 mL/min. At or above 30, renal impairment does not require a dose change. Limits and monitoring Measure serum creatinine before every injection. Verify the current injection label before use of this dated FDA source.
Review 3 product or source cautions
Verify the current prescribing information for this presentation.
Prescribing information revised 04/2015 | Selected sections checked 2026-11-07. Independent clinical review pending.
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