Everolimus

Preview FDA label, Hikma Pharmaceuticals USA Inc., oral, effective 2026-08-14. Full label on DailyMed

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using. Not yet reviewed by a ClinDose pharmacist.

Dosing in kidney impairment

Recommended Dosage for Renal Cell Carcinoma (RCC) The recommended dosage of Everolimus is 10 mg orally once daily until disease progression or unacceptable toxicity.

Recommended Dosage for Tuberous Sclerosis Complex (TSC)-Associated Renal Angiomyolipoma The recommended dosage of Everolimus is 10 mg orally once daily until disease progression or unacceptable toxicity.

Mild hepatic impairment (Child-Pugh class A) – 7.5 mg orally once daily; decrease the dose to 5 mg orally once daily if a dose of 7.5 mg once daily is not tolerated.Moderate hepatic impairment (Child-Pugh class B) – 5 mg orally once daily; decrease the dose to 2.5 mg orally once daily if a dose of 5 mg once daily is not tolerated.Severe hepatic impairment (Child-Pugh class C) – 2.5 mg orally once daily if the desired benefit outweighs the risk; do not exceed a dose of 2.5 mg once daily.
IndicationDose Modification for Everolimus
RCC and TSC-Associated Renal Angiomyolipoma
•••
Reduce dose to 2.5 mg once daily.May increase dose to 5 mg once daily if tolerated.Resume dosage administered prior to inhibitor initiation, once the inhibitor is discontinued for 3 days.
IndicationDosage Modification for Everolimus
RCC and TSC-Associated Renal Angiomyolipoma
•••
Reduce dose to 5 mg once daily.May increase dose to 7.5 mg once daily if tolerated.Resume dosage administered prior to cannabidiol oral solution initiation, once cannabidiol oral solution is discontinued for 3 days.
IndicationDosage Modification for Everolimus
RCC and TSC-Associated Renal Angiomyolipoma
•••
Avoid coadministration where alternatives exist.If coadministration cannot be avoided, double the daily dose using increments of 5 mg or less. Multiple increments may be required. Resume the dosage administered prior to inducer initiation, once an inducer is discontinued for 5 days.
IndicationDosage Modification for Everolimus
RCC and TSC-Associated Renal Angiomyolipoma
•••

Dosing in liver impairment

Dosage Modifications for Hepatic Impairment The recommended dosages of Everolimus for patients with hepatic impairment are described in Table 3 [see Use in Specific Populations] : Table 3: Recommended Dosage Modifications for Patients with Hepatic Impairment Indication Dose Modification for Everolimus RCC and TSC-Associated Renal Angiomyolipoma

Mild hepatic impairment (Child-Pugh class A) – 7.5 mg orally once daily; decrease the dose to 5 mg orally once daily if a dose of 7.5 mg once daily is not tolerated.

Moderate hepatic impairment (Child-Pugh class B) – 5 mg orally once daily; decrease the dose to 2.5 mg orally once daily if a dose of 5 mg once daily is not tolerated.

Severe hepatic impairment (Child-Pugh class C) – 2.5 mg orally once daily if the desired benefit outweighs the risk; do not exceed a dose of 2.5 mg once daily. Abbreviations: RCC, Renal Cell Carcinoma; TSC, Tuberous Sclerosis Complex.

Mild hepatic impairment (Child-Pugh class A) – 7.5 mg orally once daily; decrease the dose to 5 mg orally once daily if a dose of 7.5 mg once daily is not tolerated.Moderate hepatic impairment (Child-Pugh class B) – 5 mg orally once daily; decrease the dose to 2.5 mg orally once daily if a dose of 5 mg once daily is not tolerated.Severe hepatic impairment (Child-Pugh class C) – 2.5 mg orally once daily if the desired benefit outweighs the risk; do not exceed a dose of 2.5 mg once daily.
IndicationDose Modification for Everolimus
RCC and TSC-Associated Renal Angiomyolipoma
•••

Preparation and administration

Administration and Preparation

Administer Everolimus at the same time each day.

Administer Everolimus consistently either with or without food [see Clinical Pharmacology] .

If a dose of Everolimus is missed, it can be administered up to 6 hours after the time it is normally administered. After more than 6 hours, the dose should be skipped for that day. The next day, Everolimus should be administered at its usual time. Double doses should not be administered to make up for the dose that was missed.

Everolimus should be swallowed whole with a glass of water. Do not break or crush tablets.

Calculators for everolimus