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 Indications XENICAL acts locally to inhibit GI lipases, blocking the absorption of approximately 30% of dietary fat. 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 of weight regain after prior weight loss. XENICAL is indicated for obese patients with an initial BMI of >30 kg/m2 or >27 kg/m2 in the presence of other risk factors, such as type 2 diabetes, hypertension and dyslipidemia. How XENICAL Works 
How fat blocking works
Back to top Efficacy In clinical trials, XENICAL plus diet:
Year 1: Faster and greater weight loss 57 
In one study, three times as many patients (25% on XENICAL plus diet versus 8% on placebo plus diet, P<0.001) lost>10% of their body weight from randomization (mean: 31 lbs; range: 18 to 67 lbs).18 In five studies:
In one study, almost four times as many patients on XENICAL plus diet maintained a weight loss of >10% of their body weight from randomization versus those on placebo plus diet. In four studies:
Dyslipidemia Sustained weight loss with improvement in cardiovascular risk factors LDL cholesterol: patients with LDL of >130 mg/dL at randomization
Hypertension XENICAL plus diet improved both systolic and diastolic blood pressures versus placebo plus diet. 
The long-term effects of orlistat on morbidity and mortality associated with obesity have not been established. Type 2 Diabetes Efficacy and safety demonstrated in a 1-year study of obese type 2 diabetics on sulfonylureas (n=321) 28 
Significantly more patients on XENICAL plus diet reduced or discontinued sulfonylurea usage versus those on placebo plus diet (43.2% vs. 28.9%, P<0.05), with significantly greater reductions in mean dosage (P<0.05). 
The long-term effects of orlistat on morbidity and mortality associated with obesity have not been established. Back to top Contraindications and Warnings
Back to top Precautions Fat-Soluble Vitamins When taking XENICAL, patients should be advised to take a multivitamin supplement containing fat-soluble vitamins to ensure adequate nutrition, because XENICAL has been shown to reduce the absorption of some fat-soluble vitamins, including beta-carotene, and because the status of obese patients in general and patients on weight-control diets may be low. The supplement should be taken once a day at least 2 hours before or after administration of XENICAL, such as bedtime. Toxicology No evidence of bacterial or mammalian mutagenicity, unscheduled DNA synthesis, chromosome aberrations or mouse micronuclei was seen in bacterial and animal studies. No evidence of carcinogenicity existed in animals with systemic exposure to orlistat many times higher than that used in human studies. Inappropriate Use As with any weight-loss agent, the potential exists for misuse of XENICAL in inappropriate patient populations (e.g., patients with anorexia nervosa or bulimia). See recommended prescribing guidelines for more detail. Pregnancy Category B XENICAL is not recommended for use during pregnancy. Nursing Mothers XENICAL should not be taken by nursing mothers. Back to top Adverse Events Gastrointestinal symptoms are the most commonly observed (incidence of 5% of more, and twice that of placebo) adverse events associated with the use of XENICAL in the double-blind, placebo-controlled clinical trials, and are primarily a manifestation of the mechanism of action. The most common of these adverse events were oily spotting, flatus with discharge, fecal urgency, fatty/oily stool, oily evacuation, increased defecation and fecal incontinence. Back to top Dosage and Administration
Back to top Mechanism of Action Physicians' FAQ Managing Patients with Obesity-Related Comorbidities | |||||||||||||||||||||||||||||||||||||||||||
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