Some people on alli™ will experience GI side effects, which is expected since alli works by inhibiting about 25% of dietary fat. alli is half the strength of prescription Xenical® (orlistat 120 mg), and, as a result, has fewer GI events overall than Xenical®. In clinical trials, subjects on 120 mg withdrew due to GI adverse events at a rate of 5.4%-and at 60 mg it was only 3.2%.

The main treatment effect occurs when an individual eats a meal with too much fat while taking alli. Treatment effects may include:

• Loose or more frequent stools that may be hard to control
• An urgent need to go to the bathroom
• Gas with oily spotting
• While excess fat that is excreted is not harmful, patients could be distressed by the experience. Treatment effects can be lessened if an individual sticks with reduced-calorie, low-fat meals that average 15 grams of fat per meal (or 30% fat or less). Diets may vary from 1,200 calories to 1,800 calories per day, so 15 grams is an average. Individuals need to be aware of hidden fat in food, so that they can lower the chance of having treatment effects.

Not all individuals will experience treatment effects, but those that do can reduce the likelihood of these effects by taking alli as directed and sticking with a reduced-calorie, low-fat diet. The alli starter pack includes portable reference guides and online support at myalli.com to help patients follow the program accurately. Some patients may experience treatment effects as they begin therapy until they learn to adjust their diet.

Patients should not use alli if they have had an organ transplant or if they are taking medicine to reduce organ rejection.

alli™ has low potential for misuse and drug interactions because of the mechanism of action and minimal systemic absorption. The only known drug interactions can occur with cyclosporine and warfarin (blood-thinning medicine).

Patients should not use alli if taking cyclosporine; alli can reduce levels of cyclosporine in the blood.

Patients on warfarin should talk with their doctor before taking alli; they will need to be monitored closely for changes in coagulation parameters and have their blood tested regularly, which is standard for any individual taking warfarin who is considering starting a new concomitant drug.

Patients taking medicine for thyroid disease should talk to their doctor before taking alli.

alli does not negatively interfere with diabetes medication; In fact, a clinical trial has demonstrated that patients taking orlistat have been able to reduce or discontinue their diabetes medicine.¹

No clinically relevant drug interactions were seen when alli was taken in combination with weight loss drugs, such as phentermine or sibutramine.²

References
¹ Miles J, Leiter L, Hollander P, et al. Effect of orlistat in overweight and obese patients with type 2 diabetes treated with metformin. Diabetes Care. 2002;25:1123-1128.
² Zhi J, Moore R, Kanitra L, Mulligan TE. Pharmacokinetic evaluation of the possible interaction between selected concomitant medications and orlistat at steady state in healthy subjects. Amer Coll Clin Pharmacol. 2002;42:1011-1019.

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