From the Guidelines
Sunitinib is administered orally, with the recommended dose being either 37.5 mg once daily without interruption or 50 mg once daily on a schedule of 4 weeks on treatment followed by 2 weeks off. The administration route of Sunitinib (Sutent) is oral, and it can be taken with or without food consistently 1. Patients should swallow the capsules whole with water and not open them.
Key Administration Details
- The standard dosing regimen for most cancers is 50 mg once daily for 4 weeks, followed by a 2-week rest period, creating a complete 6-week treatment cycle, often referred to as the "4/2 schedule" 1.
- Alternative dosing schedules include continuous daily dosing of 37.5 mg without breaks, which may be used in some cases 1.
- Dose adjustments may be necessary based on individual tolerability and side effects, which should be monitored regularly.
Considerations for Administration
- Sunitinib dose modification is recommended in patients who must receive concomitant CYP3A4 inhibitors or inducers 1.
- A dose reduction for sunitinib to a minimum of 37.5 mg daily should be considered if sunitinib must be coadministered with a strong CYP3A4 inhibitor 1.
- A dose increase for sunitinib to a maximum of 87.5 mg daily should be considered if sunitinib must be co-administered with a CYP3A4 inducer 1.
The most recent and highest quality study, from 2022, supports the oral administration of sunitinib, with specific dosing regimens and considerations for concomitant medications 1.
From the FDA Drug Label
Drug Name: sunitinib (PO)
The pharmacokinetics of sunitinib and sunitinib malate have been evaluated in healthy subjects and in patients with solid tumors.
Following oral administration of sunitinib, the time to maximum plasma concentration (T max) ranged from 6 to 12 hours
The administration route of Sunitinib (Sutent) is oral.
- The drug is taken by mouth, as indicated by the "(PO)" in the drug name and the description of oral administration in the pharmacokinetics section.
- The pharmacokinetics of sunitinib support oral administration, with details on absorption and time to maximum plasma concentration provided 2
From the Research
Administration Route of Sunitinib
Dosage Schedules
- Sunitinib can be administered on a 4-weeks-on/2-weeks-off schedule (4/2 schedule) 3, 4, 6, 7.
- An alternative schedule of 2 weeks on/1 week off (2/1 schedule) has also been explored 5, 6, 7.
- The 2/1 schedule has been shown to have a lower toxicity profile and better efficacy with improved progression-free survival (PFS) compared to the 4/2 schedule 6, 7.
Dosing
- The recommended dose of sunitinib is 50 mg orally daily for 4 weeks, followed by 2 weeks off treatment (4/2 schedule) 4.
- A dose of 25 mg/day in a 2-weeks-on/1-week-off regimen has also been used 5.
- The dose can be modulated (between 25 and 50 mg/day) and/or schedules can be adjusted to optimize the benefit-risk profile of sunitinib in individual patients 3.