Usual Adult Dose for Renal Cell Carcinoma

50 mg orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off

Comment: May be taken with or without food.

Uses:

• For the treatment of advanced renal cell carcinoma (RCC)
• For the treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib.

Usual Adult Dose for Gastrointestinal Stromal Tumor

50 mg orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off

Comment: May be taken with or without food.

Uses:

• For the treatment of advanced renal cell carcinoma (RCC)
• For the treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib.

Usual Adult Dose for Pancreatic Cancer

37.5 mg orally once daily

Comments:

• To be taken continuously without a scheduled off-treatment period; may be taken with or without food.

Use: For the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced or metastatic disease.

Renal Dose Adjustments

• Mild, moderate or severe renal impairment: No dose adjustment is recommended.
• End-stage renal disease (ESRD) on dialysis: No dose adjustment recommended to starting dose, however subsequent doses may be increased gradually up to 2-fold based on safety and tolerability.
• If 24-hour urine protein exceeds 3 grams; interrupt therapy and reduce dose; for recurrences after dose reduction, discontinue therapy.
• Discontinue therapy in patients with nephrotic syndrome.

Liver Dose Adjustments

• Mild to moderate hepatic impairment (Child-Pugh A or B): No dose adjustment is recommended.
• Severe hepatic impairment (Child-Pugh C): No specific guidelines have been suggested as drug has not been studied in these patients.
• If grade 3 or 4 hepatic adverse events develop, interrupt therapy; discontinue therapy if there is no resolution or if subsequent severe changes in liver function tests or other signs and symptoms of hepatic failure occur.

Dose Adjustments

Dose interruption and/or dose modification may be made in 12.5 mg increments or decrements based on individual safety and tolerability.

• The maximum dose administered during the phase 3 pNET study was 50 mg orally once daily.

Concomitant Use With Strong CYP450 3A4 Inhibitors and Inducers:

• Strong CYP450 3A4 inhibitors may increase sunitinib exposure
• Strong CYP450 3A4 inducers may decrease sunitinib exposure

Recommendations:

• Select an alternative concomitant medication with no or minimal CYP450 3A4 inhibition or induction.
• If coadministration with strong CYP450 3A4 inhibitors is necessary, consider reducing sunitinib dosage to a minimum of 37.5 mg in patients with GIST or RCC, or 25 mg once daily for patients with pNET.
• If coadministration with strong CYP450 3A4 inducers is necessary, consider increasing sunitinib dosage to a maximum of 87.5 mg in patients with GIST or RCC, or 62.5 mg once daily for patients with pNET. Monitor closely for toxicity.

Left Ventricular Dysfunction:

• Interrupt therapy and/or reduce dosage in patients without clinical evidence of CHF but with an ejection fraction less than 50% and greater than 20% below baseline.
• For patients with clinical evidence of CHF, treatment discontinuation is recommended.

Precautions

US BOXED WARNING:
Hepatotoxicity

• Hepatotoxicity has been observed in clinical trials and reported postmarketing.
• Cases may be severe; deaths have been reported

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration Advice:

• May be taken with or without food
• Do not open capsules
• If dose is missed, may take as soon as remembered if not too close to next dose. If close to next dose, take next dose at your scheduled time. Do not take more than 1 dose at a time.

General:
Therapy should be initiated by a physician experienced in the administration of anti-cancer agents.

Monitoring:

• Baseline monitoring should include a CBC with platelet count, serum chemistry including phosphate, liver function tests (ALT, AST, bilirubin), assessment of thyroid function, and urinalyses.
• Consider baseline LVEF evaluation in all patients, and an ECG in patients at risk for QT prolongation.
• Repeat CBC, serum chemistry, and liver function tests with each treatment cycle; repeat all other monitoring as clinically indicated.

Patient Advice:

• Advise patient to contact healthcare provider if they experience cardiac symptoms, hypertension, bleeding, skin or mouth reactions including jaw-bone problems, hormone (thyroid or adrenal) problems, or symptoms suggestive of tumor lysis syndrome.
• Advise patient to use effective contraception during therapy; if pregnancy is suspected, patients should seek medical advice and counseling.
• Advise patients with diabetes that it may affect blood glucose levels.

Frequently asked questions

• Does Sutent shrink tumors?
• Is Sutent considered a chemotherapy drug?