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SUTENT® (sunitinib malate) Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage for GIST and Advanced RCC

The recommended dosage of SUTENT 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. SUTENT may be taken with or without food.

2.2 Recommended Dosage for Adjuvant Treatment of RCC

The recommended dosage of SUTENT 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. SUTENT may be taken with or without food.

2.3 Recommended Dosage for pNET

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

2.4 Dosage Modifications for Adverse Reactions

Dose interruption and/or dose modification in 12.5 mg increments or decrements is recommended based on individual safety and tolerability. The maximum dose administered in the pNET study was 50 mg daily. The minimum dose administered in the adjuvant RCC study was 37.5 mg daily.

2.5 Dosage Modification for Drug Interactions

Strong CYP3A4 Inhibitors

Select an alternate concomitant medication with no or minimal enzyme inhibition potential. If coadministration of SUTENT with a strong CYP3A4 inducer cannot be avoided, consider a dose reduction for SUTENT to a minimum dosage as follows [see Drug Interactions (7.1)]:

  • 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 SUTENT with a strong CYP3A4 inducer cannot be avoided, consider a dose increase for SUTENT 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 SUTENT is increased, monitor patients carefully for adverse reactions [see Drug Interactions (7.1)].

2.6 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 [see Clinical Pharmacology (12.3)].

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