Dose or interval change
Renal measure Intravascular volume or salt depletion; no numerical renal cutoff for this starting dose Renal action or finding When intravascular volume or salt is depleted, including in some patients on hemodialysis or receiving intensive diuresis, start at 75 mg once daily. Limits and monitoring Assess volume status and blood pressure first. This lower starting dose addresses depletion; it is not a dose to repeat after every dialysis session. Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 22, effective 2026-08-24; posted Aug 31, 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 No renal dose change is required in mild through severe impairment or ESRD. Limits and monitoring Hemodialysis does not remove isavuconazole. Confirm whether an order expresses drug quantity as prodrug or active moiety. Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 21, effective 2025-04-25; posted May 05, 2025 | 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 Use of this fixed combination is not recommended at CrCl <50 mL/min or in ESRD requiring hemodialysis. Limits and monitoring Review a complete HIV regimen when individual components need adjustment. Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 5, effective 2021-02-15; posted Feb 10, 2025 | 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 CrCl 50 mL/min, use of the fixed combination is not recommended. Use individual products if either component needs reduction. Limits and monitoring Do not apply this cutoff to unrelated lamivudine combinations. Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 22, effective 2023-08-22; posted Oct 03, 2024 | Selected sections checked 2026-11-07. Independent clinical review pending.
Restriction or avoidance
Renal measure Indexed GFR/eGFR, mL/min/1.73 m2 Renal action or finding Avoid starting at eGFR 30-45. Reassess benefit and risk if eGFR subsequently falls below 45; discontinue below 30, where use is contraindicated. Limits and monitoring Check renal function before therapy and periodically. Verify immediate-release dosing frequency and contrast precautions. Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 46, effective 2026-08-19; posted Aug 26, 2026 | Selected sections checked 2026-11-07. Independent clinical review pending.
Restriction or avoidance
Renal measure Indexed GFR/eGFR, mL/min/1.73 m2 Renal action or finding Initiation at eGFR 30-45 is not recommended. During treatment, reassess if eGFR drops below 45. Stop below 30; the product is contraindicated in that range. Limits and monitoring Check renal function at baseline and periodically. Confirm the XR presentation and contrast instructions. Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 10, effective 2026-08-19; posted Aug 27, 2026 | Selected sections checked 2026-11-07. Independent clinical review pending.
Insufficient evidence
Renal measure Clinical renal category or population named in the cited section Renal action or finding The label describes use in patients with pre-existing impairment, but the effect of renal impairment on drug disposition has not been studied. Limits and monitoring Check kidney function and electrolytes, including potassium and magnesium. Confirm the liposomal formulation before use. Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 14, effective 2026-10-02; posted Oct 05, 2026 | Selected sections checked 2026-11-07. Independent clinical review pending.
Monitoring or toxicity
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 In mild or moderate impairment, no dose reduction is required; monitor renal function and adverse effects. Severe impairment (eGFR 15 to <30) has very limited experience and requires close monitoring. Use is not recommended in ESRD. Limits and monitoring GI adverse effects can produce dehydration and worsen kidney function. Verify the single-ingredient pen and the dated source. Review 1 product or source caution
Verify the current prescribing information for this presentation.
Prescribing information revised 9/2023 | 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 alone does not require dose reduction. With intravascular depletion, start the adult hypertension regimen at 25 mg daily. Limits and monitoring Monitor renal function in susceptible patients. Consider withholding therapy for a clinically significant decline. Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 9, effective 2026-01-20; posted Jan 21, 2026 | Selected sections checked 2026-11-07. Independent clinical review pending.
Insufficient evidence
Renal measure Creatinine clearance (CrCl), mL/min; use the product-specific calculation Renal action or finding Safety and effectiveness have not been established in severe renal impairment, defined as CrCl <30 mL/min. Limits and monitoring Monitor renal function and potassium. Reassess the combination if renal function declines significantly. Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 10, effective 2025-11-26; posted Nov 28, 2025 | Selected sections checked 2026-11-07. Independent clinical review pending.
Dose or interval change
Renal measure Creatinine clearance (CrCl), mL/min; use the product-specific calculation Renal action or finding At CrCl below 50 mL/min, start at 20 mg daily and limit the dose to 80 mg daily. Limits and monitoring This includes both CrCl 30 to below 50 and CrCl below 30. Check interacting CYP3A4 drugs before titration. Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 37, effective 2025-01-31; posted Jan 14, 2026 | 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 Start with the usual dose for the infection. CrCl >50: usual dose every 8 hours. At 26-50: usual dose every 12 hours. At 10-25: half the usual dose every 12 hours. Below 10: half the usual dose every 24 hours. Limits and monitoring The FDA label has insufficient information for hemodialysis or peritoneal dialysis. Separate institutional regimens carry their own assumptions. Review 1 product or source caution
Verify the current prescribing information for this presentation.
Prescribing information revised 12/2024 | Selected sections checked 2026-11-07. Independent clinical review pending.
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