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Everolimus Dosage

Medically reviewed by Drugs.com. Last updated on Apr 15, 2024.

Applies to the following strengths: 0.25 mg; 0.5 mg; 0.75 mg; 2.5 mg; 5 mg; 10 mg; 7.5 mg; 1 mg; 2 mg; 3 mg

Usual Adult Dose for Breast Cancer

10 mg orally once a day
Duration of therapy: Continue until disease progression or unacceptable toxicity occurs.

Comments:


Uses:
1) Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer (Advanced HR+ BC): For postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane, after failure of treatment with letrozole or anastrozole
2) Advanced Neuroendocrine Tumors (NET):
3) Advanced Renal Cell Carcinoma (RCC): For advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib
4) For Renal Angiomyolipoma with Tuberous Sclerosis Complex (TSC): For renal angiomyolipoma and TSC, not requiring immediate surgery

Usual Adult Dose for Renal Cell Carcinoma

10 mg orally once a day
Duration of therapy: Continue until disease progression or unacceptable toxicity occurs.

Comments:


Uses:
1) Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer (Advanced HR+ BC): For postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane, after failure of treatment with letrozole or anastrozole
2) Advanced Neuroendocrine Tumors (NET):
3) Advanced Renal Cell Carcinoma (RCC): For advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib
4) For Renal Angiomyolipoma with Tuberous Sclerosis Complex (TSC): For renal angiomyolipoma and TSC, not requiring immediate surgery

Usual Adult Dose for Pancreatic Cancer

10 mg orally once a day
Duration of therapy: Continue until disease progression or unacceptable toxicity occurs.

Comments:


Uses:
1) Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer (Advanced HR+ BC): For postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane, after failure of treatment with letrozole or anastrozole
2) Advanced Neuroendocrine Tumors (NET):
3) Advanced Renal Cell Carcinoma (RCC): For advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib
4) For Renal Angiomyolipoma with Tuberous Sclerosis Complex (TSC): For renal angiomyolipoma and TSC, not requiring immediate surgery

Usual Adult Dose for Renal Angiomyolipoma

10 mg orally once a day
Duration of therapy: Continue until disease progression or unacceptable toxicity occurs.

Comments:


Uses:
1) Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer (Advanced HR+ BC): For postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane, after failure of treatment with letrozole or anastrozole
2) Advanced Neuroendocrine Tumors (NET):
3) Advanced Renal Cell Carcinoma (RCC): For advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib
4) For Renal Angiomyolipoma with Tuberous Sclerosis Complex (TSC): For renal angiomyolipoma and TSC, not requiring immediate surgery

Usual Adult Dose for Neuroendocrine Carcinoma

10 mg orally once a day
Duration of therapy: Continue until disease progression or unacceptable toxicity occurs.

Comments:


Uses:
1) Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer (Advanced HR+ BC): For postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane, after failure of treatment with letrozole or anastrozole
2) Advanced Neuroendocrine Tumors (NET):
3) Advanced Renal Cell Carcinoma (RCC): For advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib
4) For Renal Angiomyolipoma with Tuberous Sclerosis Complex (TSC): For renal angiomyolipoma and TSC, not requiring immediate surgery

Usual Adult Dose for Brain/Intracranial Tumor

4.5 mg/m2 orally once a day
Duration of therapy: Continue until disease progression or unacceptable toxicity occurs. The optimal duration of therapy is unknown.

Comments:


Use: Subependymal Giant Cell Astrocytoma (SEGA) with Tuberous Sclerosis Complex (TSC): For tuberous sclerosis complex (TSC) for the treatment of SEGA that requires therapeutic intervention but cannot be curatively resected

Usual Adult Dose for Organ Transplant - Rejection Prophylaxis

KIDNEY transplant: 0.75 mg orally twice a day
Comments:


LIVER transplant: 1 mg orally twice a day
Comments:

Uses:

Usual Adult Dose for Seizures

5 mg/m2 orally once a day until disease progression or unacceptable toxicity

Comments:


Use: For adjunctive treatment of TSC-associated partial-onset seizures

Usual Pediatric Dose for Brain/Intracranial Tumor

One year and older:
4.5 mg/m2 orally once a day
Duration of therapy: Continue until disease progression or unacceptable toxicity occurs. The optimal duration of therapy is unknown.

Comments:


Use: Subependymal Giant Cell Astrocytoma (SEGA) with Tuberous Sclerosis Complex (TSC): For tuberous sclerosis complex (TSC) for the treatment of SEGA that requires therapeutic intervention but cannot be curatively resected in pediatric patients 1 year and older

Usual Pediatric Dose for Seizures

5 mg/m2 orally once a day until disease progression or unacceptable toxicity

Comments:


Use: For adjunctive treatment of pediatric patients 2 years and older with TSC-associated partial-onset seizures

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

DOSE MODIFICATIONS IN BREAST CANCER, NET, RCC, AND TSC-ASSOCIATED RENAL ANGIOMYOLIPOMA:


DOSE MODIFICATIONS IN TSC-ASSOCIATED SEGA AND TSC-ASSOCIATED PARTIAL-ONSET SEIZURES:

DOSE MODIFICATIONS FOR ORGAN TRANSPLANT-REJECTION PROPHYLAXIS:

Dose Adjustments

THERAPEUTIC DRUG MONITORING AND DOSE TITRATION FOR TUBEROUS SCLEROSIS COMPLEX (TSC)-ASSOCIATED SUBEPENDYMAL GIANT CELL ASTROCYTOMA (SEGA) AND TSC-ASSOCIATED PARTIAL-ONSET SEIZURES:

MANUFACTURER RECOMMENDED TIME POINTS:

DOSE MODIFICATIONS IN BREAST CANCER, NET, RCC, AND TSC-ASSOCIATED RENAL ANGIOMYOLIPOMA:
---NON-INFECTIOUS PNEUMONITIS---
----STOMATITIS----
----METABOLIC EVENTS (e.g., HYPERGLYCEMIA, DYSLIPIDEMIA)----
----OTHER NONHEMATOLOGIC TOXICITIES----
Grade 3: Interrupt therapy until recovery to Grade 0 or 1; consider resuming at 50% of previous dose; change to every other day dosing if the reduced dose is lower than the lowest available strength; if toxicity recurs at Grade 3, permanently discontinue therapy
Grade 4: Permanently discontinue therapy
----THROMBOCYTOPENIA----
----NEUTROPENIA----
----FEBRILE NEUTROPENIA----
----CYP450 3A4/P-GLYCOPROTEIN (PGP) INHIBITORS----

DOSAGE MODIFICATIONS FOR P-GP AND CYP450 3A4 INHIBITORS:
MANUFACTURER RECOMMENDED DOSAGE MODIFICATIONS FOR CONCURRENT USE OF THIS DRUG WITH A PGP AND MODERATE CYP450 3A4 INHIBITOR IN BREAST CANCER, NET, RCC, AND TSC-ASSOCIATED RENAL ANGIOMYOLIPOMA:
MANUFACTURER RECOMMENDED DOSAGE MODIFICATIONS FOR CONCURRENT USE OF THIS DRUG WITH A PGP AND MODERATE CYP450 3A4 INHIBITOR IN TSC-ASSOCIATED SEGA AMD TSC-ASSOCIATED PARTIAL-ONSET SEIZURES:

DOSAGE MODIFICATIONS FOR P-GP AND CYP450 3A4 INDUCERS:
MANUFACTURER RECOMMENDED DOSAGE MODIFICATIONS FOR CONCURRENT USE OF THIS DRUG WITH PGP AND CYP450 3A4 INDUCERS IN BREAST CANCER, NET, RCC, AND TSC-ASSOCIATED RENAL ANGIOMYOLIPOMA:
MANUFACTURER RECOMMENDED DOSAGE MODIFICATIONS FOR TSC-
ASSOCIATED SEGA AND TSC-ASSOCIATED PARTIAL-ONSET SEIZURES:

DOSE MODIFICATIONS IN KIDNEY OR LIVER TRANSPLANT:
Patients may require dose adjustments based on everolimus blood concentrations achieved, tolerability, individual response, change in concomitant medications and the clinical situation. Dose adjustments should be based on trough concentrations taken 4 or 5 days after a previous dosing change. Dose adjustment is required if the trough concentration is below 3 ng/mL. The total daily dose should be doubled using the available tablet strengths (0.25 mg, 0.5 mg or 0.75 mg). Dose adjustment is also required if the trough concentration is greater than 8 ng/mL on 2 consecutive measures; the dose should be decreased by 0.25 mg twice daily.

Precautions

US BOXED WARNINGS:
Zortress (R):


CONTRAINDICATIONS:

Afinitor (R): Safety and efficacy have not been established in patients younger than 1 year.
Zortress (R): Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:


General:

Storage requirements:

Reconstitution/preparation techniques:
Afinitor Disperz(R):

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.