Restriction or avoidance
Renal measure Creatinine clearance (CrCl), mL/min; use the product-specific calculation Renal action or finding CrCl 35-60 mL/min permits the usual renal dose. Below 35, the label recommends against use. Limits and monitoring Use the effervescent preparation instructions. Check the product sodium content for patients with sodium restriction. Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 6, effective 2026-02-06; posted Feb 16, 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 At CrCl 35-60 mL/min, retain the indication-specific dose. Below 35, use is not recommended. Limits and monitoring Confirm the tablet strength and dosing frequency. This is the single-ingredient product. Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 10, effective 2026-03-12; posted Mar 16, 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 No change is specified for CrCl 35-60 mL/min. Use is not recommended below 35. Limits and monitoring Check the combination strength and vitamin D content before using this product. Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 10, effective 2026-02-03; posted Feb 16, 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 Clinical renal category or population named in the cited section Renal action or finding For severe renal impairment start with 6.25 mg. Limit the total to 12.5 mg in 24 hours. Limits and monitoring The selected dosing paragraph uses a severity category. Verify full acute-migraine dosing and contraindications. Review 1 product or source caution
Verify the current prescribing information for this presentation.
DailyMed SPL version 2, effective 2012-10-10; posted Oct 25, 2012 | 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 No renal adjustment is recommended at CrCl 30 to below 90 mL/min. Limits and monitoring The effect of CrCl below 30 on alpelisib exposure is unknown. Keep Piqray distinct from other alpelisib products. Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 14, effective 2026-10-28; posted Nov 05, 2026 | Selected sections checked 2026-11-07. Independent clinical review pending.
Dose or interval change
Renal measure MDRD estimate, mL/min/1.73 m2 Renal action or finding At 60-89, start 137 mg at bedtime and increase after one week to 274 mg. At 30-59, start 68.5 mg at bedtime and, if needed after one week, increase to 137 mg. At 15-29, use 68.5 mg at bedtime. Below 15, use is contraindicated. Limits and monitoring The label uses an MDRD-derived value in mL/min/1.73 m2 although it calls it creatinine clearance. Do not substitute an unindexed Cockcroft-Gault value. Review 2 product or source cautions
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 8, effective 2026-10-05; posted Oct 06, 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 modification is necessary. Limits and monitoring Apply the usual indication-specific regimen. The renal subsection does not provide a dialysis timing instruction. Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 12, effective 2026-03-02; posted Mar 05, 2026 | Selected sections checked 2026-11-07. Independent clinical review pending.
Dose or interval change
Renal measure Clinical renal category or population named in the cited section Renal action or finding In mild or moderate renal impairment, the test dose and starting dose are each 1 mg (0.1 mL of the 10 mg/mL product). Limits and monitoring Give the initial test dose under clinician supervision with supine and standing blood pressure monitoring. Do not transfer the volume to an infusion product. Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 21, effective 2024-10-10; posted Oct 14, 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 Renal impairment does not require lowering the atorvastatin dose. Limits and monitoring Renal impairment increases myopathy/rhabdomyolysis risk. Monitor for muscle symptoms and assess interacting drugs. Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 8, effective 2024-04-15; posted Jul 15, 2026 | Selected sections checked 2026-11-07. Independent clinical review pending.
No adjustment within stated limits
Renal measure Cockcroft-Gault creatinine clearance, mL/min Renal action or finding At CrCl 30-89 mL/min, no renal reduction is recommended. No dose has been established at CrCl 15-29 or below 15. Limits and monitoring Confirm the indication-specific starting dose. Neither severe impairment nor ESRD has an established renal regimen here. Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 16, effective 2026-10-20; posted Oct 26, 2026 | 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 Mild to severe pre-existing renal impairment does not require a lower starting dose. Use caution below CrCl 15 mL/min. Limits and monitoring The recommendation is based on population pharmacokinetics. On-treatment toxicities may require dose changes. Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 12, effective 2026-03-12; posted Mar 16, 2026 | Selected sections checked 2026-11-07. Independent clinical review pending.
Dose or interval change
Renal measure Indexed GFR/eGFR, mL/min/1.73 m2 Renal action or finding At GFR <30 mL/min/1.73 m2, the adult starting dose is 5 mg once daily. Titrate against blood pressure to a maximum of 40 mg/day. Limits and monitoring Check serum potassium and renal function. This adult starting dose cannot be used as a pediatric regimen. Review 1 product or source caution
Apply only to the stated formulation, indication and renal population.
DailyMed SPL version 10, effective 2025-09-30; posted Oct 02, 2025 | Selected sections checked 2026-11-07. Independent clinical review pending.
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