Indication

XENICAL is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. XENICAL is also indicated to reduce the risk for weight regain after prior weight loss. XENICAL is indicated for obese patients with an initial body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia).

Important Safety Information

XENICAL is contraindicated in patients:

• who are pregnant. Weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy
• with chronic malabsorption syndrome
• with cholestasis
• with known hypersensitivity to XENICAL or to any component of this product

Warnings and Precautions:

• XENICAL may interact with concomitant drugs including cyclosporine, levothyroxine, warfarin, amiodarone, antiepileptic drugs, and antiretroviral drugs
• XENICAL can decrease cyclosporine exposure. XENICAL and cyclosporine should not be simultaneously co-administered
• Patients should be strongly encouraged to take a multivitamin supplement that contains fat-soluble vitamins to ensure adequate nutrition because XENICAL has been shown to reduce the absorption of some fat-soluble vitamins and beta-carotene
• Rare cases of severe liver injury with hepatocellular necrosis or acute hepatic failure have been reported, with some of these cases resulting in liver transplant or death
• Patients may develop increased levels of urinary oxalate following treatment with XENICAL. Monitor renal function in patients at risk for renal insufficiency.
• Substantial weight loss can increase the risk of cholelithiasis
• Exclude organic causes of obesity (e.g., hypothyroidism) before prescribing XENICAL
• Patients should be advised to adhere to dietary guidelines. Gastrointestinal events may increase when XENICAL is taken with a diet high in fat (>30% total daily calories from fat)

It is not known if XENICAL is present in human milk. Caution should be exercised when XENICAL is administered to a nursing woman.

The most commonly observed adverse events (incidence of ≥5% and twice that of placebo) were oily spotting, flatus with discharge, fecal urgency, fatty/oily stool, oily evacuation, increased defecation and fecal incontinence. In general, the first occurrence of these events was within 3 months of starting therapy.

Overall, approximately 50% of all episodes of GI adverse events associated with XENICAL treatment lasted for less than 1 week, and a majority lasted for no more than 4 weeks. However, GI adverse events may occur in some individuals over a period of 6 months or longer.

Report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
Patients and caregivers may also report side effects to the Safety Call Center at 1-888-236-5445.