Advanced Renal Cell Carcinoma, Advanced Progressive Neuroendocrine Tumors, Advanced Neuroendocrine Tumors, Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer, and Renal Angiomyolipoma with Tuberous Sclerosis Complex (Afinitor)

• PO (Adults ): 10 mg once daily until disease progression or unacceptable toxicity; Concurrent use of P-glycoprotein (P-gp) inhibitor and moderate CYP3A4 inhibitor: 2.5 mg once daily until disease progression or unacceptable toxicity; Concurrent use of P-gp inducer and strong CYP3A4 inducer:↑ dose in 5 mg increments up to 20 mg once daily; continue until disease progression or unacceptable toxicity.

Hepatic Impairment

• PO (Adults ): Mild hepatic impairment: 7.5 mg once daily until disease progression or unacceptable toxicity; may ↓ to 5 mg once daily if not well tolerated; Moderate hepatic impairment: 5 mg once daily until disease progression or unacceptable toxicity; may ↓ to 2.5 mg once daily if not well tolerated; Severe hepatic impairment: 2.5 mg once daily until disease progression or unacceptable toxicity.

Subependymal Giant Cell Astrocytoma with Tuberous Sclerosis Complex (Afinitor)

• PO (Adults and Children ≥1 yr): 4.5 mg/m² once daily. Titrate, as needed, at 2-wk intervals to achieve recommended whole blood trough concentration. Continue until disease progression or unacceptable toxicity; Concurrent use of P-gp inhibitor and moderate CYP3A4 inhibitor: 2.25 mg/m² once daily. Titrate, as needed, at 2-wk intervals to achieve recommended whole blood trough concentration. Continue until disease progression or unacceptable toxicity; Concurrent use of P-gp inducer and strong CYP3A4 inducer: 9 mg/m² once daily. Titrate, as needed, at 2-wk intervals to achieve recommended whole blood trough concentration. Continue until disease progression or unacceptable toxicity.

Hepatic Impairment

• PO (Adults and Children ≥1 yr): Severe hepatic impairment: 2.5 mg/m² once daily. Titrate, as needed, at 2-wk intervals to achieve recommended whole blood trough concentration. Continue until disease progression or unacceptable toxicity.

Tuberous Sclerosis Complex-Associated Partial-Onset Seizures (Afinitor)

• PO (Adults and Children ≥2 yr): 5 mg/m² once daily. Titrate, as needed, at 2-wk intervals to achieve recommended whole blood trough concentration. Continue until disease progression or unacceptable toxicity; Concurrent use of P-gp inhibitor and moderate CYP3A4 inhibitor: 2.5 mg/m² once daily. Titrate, as needed, at 2-wk intervals to achieve recommended whole blood trough concentration. Continue until disease progression or unacceptable toxicity; Concurrent use of P-gp inducer and strong CYP3A4 inducer: 10 mg/m² once daily. Titrate, as needed, at 2-wk intervals to achieve recommended whole blood trough concentration. Continue until disease progression or unacceptable toxicity.

Hepatic Impairment

• PO (Adults and Children ≥2 yr): Severe hepatic impairment: 2.5 mg/m² once daily. Titrate, as needed, at 2-wk intervals to achieve recommended whole blood trough concentration. Continue until disease progression or unacceptable toxicity.

Kidney Transplantation (Zortress)

• PO (Adults ): 0.75 mg twice daily (with reduced-dose cyclosporine); titrate to achieve recommended whole blood trough concentration.

Hepatic Impairment

• PO (Adults ): Mild hepatic impairment :↓ daily dose by 33%; Moderate or severe hepatic impairment:↓ daily dose by 50%.

Liver Transplantation (Zortress)

• PO (Adults ): 1 mg twice daily (with reduced-dose tacrolimus) (start ≥30 days post-transplant); titrate to achieve recommended whole blood trough concentration.

Hepatic Impairment

• PO (Adults ): Mild hepatic impairment :↓ daily dose by 33%; Moderate or severe hepatic impairment:↓ daily dose by 50%.