Dosage of Everolimus

1. Important Dosage Information

Everolimus Tablets (AFINITOR) and Everolimus Oral Suspension (AFINITOR DISPERZ) are two distinct dosage forms. The recommended dosage form should be selected based on the indication. Everolimus Tablets and Everolimus Oral Suspension must not be mixed to achieve the total dosage.

Dosage adjustment is required for patients with hepatic impairment, or those taking drugs that inhibit or induce P-glycoprotein (P-gp) and CYP3A4 enzymes.

2. Recommended Dosage for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

The recommended dosage of Everolimus Tablets (AFINITOR) is 10 mg orally once daily, continued until disease progression or unacceptable toxicity occurs.

3. Recommended Dosage for Neuroendocrine Tumors (NET)

The recommended dosage of Everolimus Tablets (AFINITOR) is 10 mg orally once daily, continued until disease progression or unacceptable toxicity occurs.

4. Recommended Dosage for Renal Cell Carcinoma (RCC)

The recommended dosage of Everolimus Tablets (AFINITOR) is 10 mg orally once daily, continued until disease progression or unacceptable toxicity occurs.

5. Recommended Dosage for Tuberous Sclerosis Complex (TSC)-Associated Renal Angiomyolipoma

The recommended dosage of Everolimus Tablets (AFINITOR) is 10 mg orally once daily, continued until disease progression or unacceptable toxicity occurs.

6. Recommended Dosage for Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA)

The recommended starting dosage of Everolimus Tablets (AFINITOR)/Everolimus Oral Suspension (AFINITOR DISPERZ) is 4.5 mg/m² (body surface area) orally once daily, continued until disease progression or unacceptable toxicity occurs.

7. Recommended Dosage for Tuberous Sclerosis Complex (TSC)-Associated Partial Seizures

The recommended starting dosage of Everolimus Oral Suspension (AFINITOR DISPERZ) is 5 mg/m² (body surface area) orally once daily, continued until disease progression or unacceptable toxicity occurs.

FDA，2022.02