Dosage of Sunitinib

1 Recommended Dosage for GIST and Advanced RCC

The recommended dosage of Sunitinib for gastrointestinal stromal tumor (GIST) and advanced renal cell  carcinoma (RCC) is 50 mg taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks  off (Schedule 4/2) until disease progression or unacceptable toxicity. Sunitinib may be taken with or without  food.  

2 Recommended Dosage for Adjuvant Treatment of RCC

The recommended dosage of Sunitinib for the adjuvant treatment of RCC is 50 mg taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2), for nine 6-week cycles. Sunitinib  may be taken with or without food.

3 Recommended Dosage for pNET

The recommended dosage of Sunitinib for pancreatic neuroendocrine tumors (pNET) is 37.5 mg taken orally  once daily until disease progression or unacceptable toxicity. Sunitinib may be taken with or without food.  

4 Dosage Modifications for Adverse Reactions

To manage adverse reactions, the recommended dosage modifications are provided in Table 1. Table 2 provides  the recommended dosage reductions of Sunitinib for adverse reactions.

5 Dosage Modification for Drug Interactions

Strong CYP3A4 Inhibitors

Select an alternate concomitant medication with no or minimal enzyme inhibition potential. If coadministration  of Sunitinib with a strong CYP3A4 inhibitor cannot be avoided, consider a dose reduction for Sunitinib to a  minimum dosage as follows:  

• GIST and RCC: 37.5 mg orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks  off (Schedule 4/2)  

• pNET: 25 mg orally once daily

Strong CYP3A4 Inducers

Select an alternate concomitant medication with no or minimal enzyme induction potential. If coadministration  of Sunitinib with a strong CYP3A4 inducer cannot be avoided, consider a dose increase for Sunitinib to a  maximum dosage as follows:  

• GIST and RCC: 87.5 mg orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks  off (Schedule 4/2)  

• pNET: 62.5 mg orally once daily  If the dose of Sunitinib is increased, monitor patients carefully for adverse reactions.  

6 Dosage Modification for End-Stage Renal Disease Patients on Hemodialysis

No starting dose adjustment is required in patients with end-stage renal disease (ESRD) on hemodialysis.  However, given the decreased exposure compared to patients with normal renal function, subsequent doses may  be increased gradually up to 2-fold based on safety and tolerability.

from FDA，2021.08