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Sutent (Sunitinib Malate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Gastrointestinal Stromal Tumor (GIST)

SUTENT is indicated for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate.

Advanced Renal Cell Carcinoma (RCC)

SUTENT is indicated for the treatment of advanced renal cell carcinoma.

Advanced Pancreatic Neuroendocrine Tumors (pNET)

SUTENT is indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in patients with unresectable locally advanced or metastatic disease.

DOSAGE AND ADMINISTRATION

Recommended Dose for GIST and RCC

The recommended dose of SUTENT for gastrointestinal stromal tumor (GIST) and advanced renal cell carcinoma (RCC) is one 50 mg oral dose taken once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2). SUTENT may be taken with or without food.

Recommended Dose for pNET

The recommended dose of SUTENT for pancreatic neuroendocrine tumors (pNET) is 37.5 mg taken orally once daily continuously without a scheduled off-treatment period. SUTENT may be taken with or without food.

Dose Modification

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 Phase 3 pNET study was 50 mg daily.

Strong CYP3A4 inhibitors such as ketoconazole may increase sunitinib plasma concentrations. Selection of an alternate concomitant medication with no or minimal enzyme inhibition potential is recommended. A dose reduction for SUTENT to a minimum of 37.5 mg (GIST and RCC) or 25 mg (pNET) daily should be considered if SUTENT must be co-administered with a strong CYP3A4 inhibitor [see Drug Interactions and Clinical Pharmacology].

CYP3A4 inducers such as rifampin may decrease sunitinib plasma concentrations. Selection of an alternate concomitant medication with no or minimal enzyme induction potential is recommended. A dose increase for SUTENT to a maximum of 87.5 mg (GIST and RCC) or 62.5 mg (pNET) daily should be considered if SUTENT must be co-administered with a CYP3A4 inducer. If dose is increased, the patient should be monitored carefully for toxicity [see Drug Interactions and Clinical Pharmacology].

DOSAGE FORMS AND STRENGTHS

12.5 mg capsules

Hard gelatin capsule with orange cap and orange body, printed with white ink "Pfizer" on the cap and "STN 12.5 mg" on the body.

25 mg capsules

Hard gelatin capsule with caramel cap and orange body, printed with white ink "Pfizer" on the cap and "STN 25 mg" on the body.

37.5 mg capsules

Hard gelatin capsule with yellow cap and yellow body, printed with black ink "Pfizer" on the cap and "STN 37.5 mg" on the body.

50 mg capsules

Hard gelatin capsule with caramel top and caramel body, printed with white ink "Pfizer" on the cap and "STN 50 mg" on the body.

HOW SUPPLIED/STORAGE AND HANDLING

12.5 mg Capsules

Hard gelatin capsule with orange cap and orange body, printed with white ink "Pfizer" on the cap, "STN 12.5 mg" on the body; available in:

Bottles of 28: NDC 0069-0550-38

25 mg Capsules

Hard gelatin capsule with caramel cap and orange body, printed with white ink "Pfizer" on the cap, "STN 25 mg" on the body; available in:

Bottles of 28: NDC 0069-0770-38

37.5 mg Capsules

Hard gelatin capsule with yellow cap and yellow body, printed with black ink "Pfizer" on the cap, "STN 37.5 mg" on the body; available in:

Bottles of 28: NDC 0069-0830-38

50 mg Capsules

Hard gelatin capsule with caramel cap and caramel body, printed with white ink "Pfizer" on the cap, "STN 50 mg" on the body; available in:

Bottles of 28: NDC 0069-0980-38

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].

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