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Sutent (Sunitinib Malate) - Indications and Dosage

 
 



1 INDICATIONS AND USAGE

SUTENT is a multi-kinase inhibitor indicated for

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

1.1 Gastrointestinal Stromal Tumor

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

1.2 Advanced Renal Cell Carcinoma

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

2 DOSAGE AND ADMINISTRATION

  • One 50-mg oral capsule 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. Dose increase or reduction of 12.5-mg increments is recommended based on individual safety and tolerability.

2.1 Recommended Dose

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

2.2 Dose Modification

Dose increase or reduction of 12.5-mg increments is recommended based on individual safety and tolerability.

Strong CYP3A4 inhibitors such as ketoconazole may increase SUTENT plasma concentrations (see 7 DRUG INTERACTIONS). 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 daily should be considered if SUTENT must be co-administered with a strong CYP3A4 inhibitor.

CYP3A4 inducers such as rifampin may decrease SUTENT plasma concentrations (see 7 DRUG INTERACTIONS). 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 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. St. John's Wort may decrease SUTENT plasma concentrations unpredictably. Patients receiving SUTENT should not take St. John's Wort concomitantly.

3 DOSAGE FORMS AND STRENGTHS

12.5-mg capsules

25-mg capsules

50-mg capsules

  • 12.5-mg capsules
  • 25-mg capsules
  • 50-mg capsules

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 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
Bottles of 30:     NDC 0069-0550-30

16.2 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
Bottles of 30:     NDC 0069-0770-30

16.3 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
Bottles of 30:     NDC 0069-0980-30

16.4 Storage

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

17 PATIENT COUNSELING INFORMATION

17.1 Gastrointestinal Disorders

Gastrointestinal disorders such as diarrhea, nausea, stomatitis, dyspepsia, and vomiting were the most commonly reported gastrointestinal events occurring in patients who received SUTENT. Supportive care for gastrointestinal adverse events requiring treatment may include anti-emetic or anti-diarrheal medication.

17.2 Skin Effects

Skin discoloration possibly due to the drug color (yellow) occurred in approximately one third of patients. Patients should be advised that depigmentation of the hair or skin may occur during treatment with SUTENT. Other possible dermatologic effects may include dryness, thickness or cracking of skin, blister or rash on the palms of the hands and soles of the feet.

17.3 Other Common Events

Other commonly reported adverse events included fatigue, high blood pressure, bleeding, swelling, mouth pain/irritation and taste disturbance.

17.4 Concomitant Medications

Patients should be advised to inform their health care providers of all concomitant medications, including over-the-counter medications and dietary supplements (see 7 DRUG INTERACTIONS).

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