Sutent Dosage/Direction for Use

For GIST and MRCC, the recommended dose of sunitinib is 50 mg taken orally once daily for 4 consecutive weeks, followed by a 2-week off period (Schedule 4/2) to comprise a complete cycle of 6 weeks.
For adjuvant treatment of RCC, the recommended dose of sunitinib is 50 mg taken orally once daily on Schedule 4/2 for nine 6-week cycles (approximately 1 year).
For pNET, the recommended dose of sunitinib is 37.5 mg taken orally once daily without a scheduled rest period.
Sunitinib may be taken with or without food.
If a dose is missed, the patient should not be given an additional dose. The patient should take the usual prescribed dose on the following day.
Dose modifications: Safety and Tolerability: For GIST and MRCC, dose modifications in 12.5 mg increments or decrements may be applied based on individual safety and tolerability up to 75 mg or down to 25 mg.
For adjuvant treatment of RCC, dose modifications in 12.5 mg decrements may be applied, based on individual safety and tolerability, down to 37.5 mg. The maximum dose administered in the Phase 3 adjuvant RCC study was 50 mg daily.
For pNET, dose modification in 12.5 mg increments or decrements may be applied based on individual safety and tolerability. The maximum dose administered in the Phase 3 pNET study was 50 mg daily.
Dose interruptions may be required based on individual safety and tolerability.
CYP3A4 Inhibition/Induction: Co-administration of sunitinib with strong CYP3A4 inducers such as rifampin, should be avoided (see Interactions). If this is not possible, the dose of sunitinib may need to be increased in 12.5 mg increments to a maximum of 87.5 mg (GIST and RCC) or 62.5 mg (pNET) daily, based on careful monitoring of tolerability.
Co-administration of sunitinib with strong CYP3A4 inhibitors, such as ketoconazole, should be avoided (see Interactions). If this is not possible, the dose of sunitinib may need to be reduced in 12.5 mg decrements to a minimum of 37.5 mg (GIST and RCC) or 25 mg (pNET) daily.
Selection of an alternate concomitant medication with no or minimal potential to induce or inhibit CYP3A4 is recommended.
Use in Pediatrics: The safety and efficacy of sunitinib in pediatric patients have not been established.
Use in the Elderly: Dose adjustments are not required in elderly patients. Approximately 34% of the subjects in clinical studies of sunitinib were 65 years of age or over. No significant differences in safety or efficacy were observed between younger and older patients.
Hepatic Insufficiency: No dose adjustment is necessary when administering sunitinib to patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. Sunitinib was not studied in subjects with severe (Child-Pugh Class C) hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Renal Insufficiency: No starting dose adjustment is required when administering sunitinib to patients with renal impairment (mild-severe) or with end-stage renal disease (ESRD) on hemodialysis. Subsequent dose adjustments should be based on individual safety and tolerability.