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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