Alli

Patient Information

The alli (orlistat 60 mg) program

The alli (orlistat 60 mg) program is a comprehensive approach to weight loss. Combining the only FDA approved, over-the-counter weight loss product, alli (orlistat 60 mg) , combined with an online action plan, the alli (orlistat 60 mg) program brings together effective medical therapy and strong behavioral support. The alli (orlistat 60 mg) program is designed to bridge the gap between weight loss medications and the patients’ role in their own healthcare and weight loss objectives.

Patients and other healthcare professionals engage in honest discussions and share resources that enable both parties to better understand the complexities involved in weight reduction.

The alli starter pack

Inside the alli™ (orlistat 60 mg) starter pack you’ll find:

• • alli (orlistat 60 mg) weight loss capsulesThe capsules are easy to swallow and are taken with each meal containing fat (up to 3 per day). They work in your digestive system to prevent about a quarter of the fat you eat from being absorbed.

• • alli (orlistat 60 mg) Shuttle™The Shuttle™ makes it easy to carry the alli (orlistat 60 mg) capsules so you can have them with you at every meal, wherever you go. It’s also a great visual reminder to use the alli (orlistat 60 mg) capsules – and it keeps them from getting lost in your purse, gym bag, or briefcase. There’s room in the Shuttle for your daily multivitamin, too.

• • Handy reference bookletsThe booklets to help you follow the alli (orlistat 60 mg) program. Check out the alli (orlistat 60 mg) “Read Me First Guide” with the keys to successful weight loss, the Welcome Guide, Companion Guide, Healthy Eating Guide, Calorie & Fat Counter, Daily Journal, and Quick Facts cards for the support you need to succeed with alli (orlistat 60 mg) .

• myall (orlistat 60 mg) plan online guidanceLosing weight takes effort and commitment. That’s why the alli (orlistat 60 mg) program includes an individually tailored online action plan. And it’s free with your purchase of alli (orlistat 60 mg) . Following a reduced-calorie, low-fat diet is a great way to start with weight loss, but participating in the action plan can give you the added direction and practical advice you need to support your goal. And that support is available 24 hours a day.

FAQs

Q. How does alli (orlistat 60 mg) work?
A. As part of an overall weight loss program, alli (orlistat 60 mg) works in conjunction with behavior modification to achieve a calorie balance that is both nutritionally sound and conducive to weight reduction.

alli (orlistat 60 mg) is the only OTC drug for weight loss that is FDA approved. It has a non-systemic mechanism of action. The unique molecular structure of alli (orlistat 60 mg) enables it to bind to and inactivate some GI lipases, which aid in the digestion of dietary fats (triglycerides). alli (orlistat 60 mg) binds to gastric and pancreatic lipases, blocking absorption of about 25% of consumed fat. Undigested fat is excreted from the body instead of turning into stored fat. The absorption of carbohydrates and proteins is not affected. alli (orlistat 60 mg) is not an appetite suppressant nor does it impact the heart or nervous system. It is minimally absorbed, and there is no residual effect once the drug is stopped.

Q. Who is the ideal candidate for alli (orlistat 60 mg) ?
A. Ideal candidates are individuals who are overweight and are motivated and ready to make lifestyle changes. They have realistic expectations for gradual, modest weight loss. These individuals are committed to a reduced-calorie, low-fat diet (no more than 15 grams of fat per meal) and eating smaller portions. An ideal candidate for alli (orlistat 60 mg) will read and follow the label directions. They understand that treatment effects (loose or more frequent stools that may be hard to control, an urgent need to go to the bathroom, gas with oily spotting) can occur if they eat too much fat in a meal while taking alli (orlistat 60 mg) . Lastly, these individuals will make the time to be more physically active.

Q. How is alli (orlistat 60 mg) different from other weight loss products available?
A. alli (orlistat 60 mg) is the only FDA approved, over-the-counter weight loss product. It combines a pill (alli (orlistat 60 mg) 60 mg orlistat) with an individually tailored, online action plan based on sound clinical practices and designed by nutritional and weight loss experts. alli (orlistat 60 mg) can help an individual achieve gradual and healthy weight loss and lose 50% more weight than dieting alone. It works in the digestive system, not the central nervous system, so it does not affect the heart or brain. Orlistat has an extensive clinical history and has been studied in more than 100 controlled clinical trials. Additionally, orlistat has been used in more than 25 million patient treatments in 145 countries worldwide.

Q. I remember the difficulties with prescription Xenical®; how will the experience with over-the-counter alli (orlistat 60 mg) be different?
Behavior Support programs are part of the foundation for successful weight loss. Xenical® provided a separate support program for patients known as Xenicare, which, at the time, was considered a comprehensive plan. But a lot has changed since the introduction of Xenical®, including consumer expectations, healthcare professional involvement within the weight loss category and consumer information utilization, namely, the sophistication of the Internet user. Applying learnings from Xenicare, our insights from consumers & healthcare professionals, and our understanding of current Internet usage, we have developed the alli (orlistat 60 mg) support program, called myalli (orlistat 60 mg) plan. The myalli (orlistat 60 mg) plan is an individually tailored support plan based on sound clinical practices and designed by nutrition and weight loss experts. It is free with the purchase of alli (orlistat 60 mg) . The myalli (orlistat 60 mg) plan.com is an extremely comprehensive online support program, including personalized online pages to view goals, check-ins with individualized feedback and advice, continuous follow-up and weekly monitoring, personalized emails on eating right/meal planning, guidance on treatment effects, online journal, menus and shopping lists, direct advice from clinical experts and a connection to a community of other alli (orlistat 60 mg) users. Research indicates that those who receive one-on-one counseling or online support may have a long-term advantage in successfully losing weight.

alli (orlistat 60 mg) is different than Xenical® because it offers informational materials with the actual product. The alli (orlistat 60 mg) starter pack includes over 200 pages of free in-pack materials to help guide individuals through the alli (orlistat 60 mg) program and set expectations for gradual weight loss, help them make healthy eating choices, monitor daily diets, and manage treatment effects. Eighty percent of patients found these materials to be very helpful. Overall, the alli (orlistat 60 mg) program offers unprecedented support and resources designed to help modify behavior by creating self-assessment and self-management skills. Assuming personal responsibility is integral to achieving sustainable weight loss.

Another difference when comparing alli (orlistat 60 mg) to Xenical® is the manageability and tolerability of GI events. In clinical studies, the 60-mg capsule of alli (orlistat 60 mg) demonstrated comparable efficacy and safety profiles to the 120-mg prescription capsule, but had a lower incidence of treatment effects, compared with the 120-mg dosage. Only a small percentage of trial subjects withdrew due to GI-AEs (5.4% on 120mg compared to only 3.2% on 60mg), further reinforcing the tolerability of the 60-mg dose. After 90 days of using alli (orlistat 60 mg) , 81% of study participants reported being satisfied or very satisfied with orlistat and 91% reported losing weight. In addition, alli (orlistat 60 mg) will tell consumers and HCPs alike that the likelihood of treatment effects is greater if individuals aren’t committed to following a reduced-calorie, low-fat diet (no more than 15 grams of fat per meal) and eating smaller portions.

Learning from experience and developing self-assessment and self-improvement skills are the cornerstones of the alli (orlistat 60 mg) program. alli (orlistat 60 mg) is not a program for everyone; without a commitment to adopting healthy habits, patients will not achieve their weight loss goals.

Description

The active ingredient in alli (orlistat 60 mg) (orlistat) has been used in the United States as a prescription-only medication at double the dose found in alli (orlistat 60 mg) . Xenical® (orlistat 120 mg/TID) was introduced in the United States in 1999 following rigorous clinical studies and FDA approval. Orlistat has an extensive clinical history. It has had 25 million patient treatments and has been studied in more than 100 controlled clinical trials.

Behavior Support programs are part of the foundation for successful weight loss. Xenical® provided a separate support program for patients known as Xenicare, which, at the time, was considered a comprehensive plan. But a lot has changed since the introduction of Xenical®, including consumer expectations, healthcare professional involvement within the weight loss category and consumer, information utilization, namely, the sophistication of the Internet user. Applying learnings from Xenicare, our insights from consumers & healthcare professionals, and our understanding of current Internet usage, we have developed the alli (orlistat 60 mg) support program, called myalli (orlistat 60 mg) plan. The myalli (orlistat 60 mg) plan is an individually tailored support plan based on sound clinical practices and designed by nutrition and weight loss experts. It is free with the purchase of alli (orlistat 60 mg) . The myalli (orlistat 60 mg) plan.com is an extremely comprehensive online support program, including personalized online pages to view goals, check-ins with individualized feedback and advice, continuous follow-up and weekly monitoring, personalized emails on eating right/meal planning, guidance on treatment effects, online journal, menus and shopping lists, direct advice from clinical experts and a connection to a community of other alli (orlistat 60 mg) users. Research indicates that those who receive one-on-one counseling or online support may have a long-term advantage in successfully losing weight.

alli (orlistat 60 mg) is different than Xenical® because it offers informational materials with the actual product. The alli (orlistat 60 mg) starter pack includes over 200 pages of free in-pack materials to help guide individuals through the alli (orlistat 60 mg) program and set expectations for gradual weight loss, help them make healthy eating choices, monitor daily diets, and manage treatment effects. Eighty percent of patients found these materials to be very helpful. Overall, the alli (orlistat 60 mg) program offers unprecedented support and resources designed to help modify behavior by creating self-assessment and self-management skills. Assuming personal responsibility is integral to achieving sustainable weight loss.

Another difference when comparing alli (orlistat 60 mg) to Xenical® is the manageability and tolerability of GI events. In clinical studies, the 60-mg capsule of alli (orlistat 60 mg) demonstrated comparable efficacy and safety profiles to the 120-mg prescription capsule, but had a lower incidence of treatment effects, compared with the 120-mg dosage. Only a small percentage of trial subjects withdrew due to GI-AEs (5.4% on 120mg compared to only 3.2% on 60-mg), further reinforcing the tolerability of the 60mg dose. After 90 days of using alli (orlistat 60 mg) , 81% of study participants reported being satisfied or very satisfied with orlistat, and 91% reported losing weight. In addition, alli (orlistat 60 mg) will tell consumers and HCPs alike that the likelihood of treatment effects is greater if individuals aren’t committed to following a reduced-calorie, low-fat diet (no more than 15 grams of fat per meal) and eating smaller portions.

alli (orlistat 60 mg) is available for oral administration in dark-blue, hard-gelatin capsules. Each capsule contains 60 mg of the active ingredient, orlistat. The capsules also contain the inactive ingredients FD&C Blue No. 2, edible ink, gelatin, iron dioxide, microcrystalli (orlistat 60 mg) ne cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, talc, titanium dioxide.

alli™ (orlistat 60 mg) is indicated for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet.

Diet and exercise are the starting points for any weight loss program. Try these first before adding alli (orlistat 60 mg) . Check with your doctor before starting any exercise program.

To determine if alli (orlistat 60 mg) capsules are right for you, find your height on the chart below. You may consider starting with alli (orlistat 60 mg) if your weight is the same or more than the weight shown for your height.

Dosage And Administration

The recommended dose of alli (orlistat 60 mg) for overweight adults 18 years and older is 1 60-mg capsule with each meal containing fat.

• do not exceed 3 capsules daily
• use with a reduced-calorie, low-fat diet until you reach your weight loss goal.

Most weight loss occurs within the first 6 months. If you stop using alli (orlistat 60 mg) , continue with a diet and exercise program. If you start to regain weight after you stop taking alli (orlistat 60 mg) , you may need to start taking alli (orlistat 60 mg) again along with your diet and exercise program.

Take a multivitamin once a day, at bedtime, when using alli (orlistat 60 mg) capsules.

How Supplied

Storage Conditions: Store at 20 – 25°C (68 – 77°F); protect drug from excessive light, humidity, and temperature over 30°C (86°F)

Alli (orlistat 60 mg) , MyAlli (orlistat 60 mg) .com, MyAlli (orlistat 60 mg) Plan.com, Alli (orlistat 60 mg) Shuttle and various design elements are trademarks of GlaxoSmithKline.

Distributed by:
GlaxoSmithKline
Consumer Healthcare, L.P.
Moon Township, PA 15108
Made in the U.S.A.

US Patent Nos. 4,598,089
6,004,996
Shuttle Patent Pending

© 2007 GlaxoSmithKline

Some people on alli™ (orlistat 60 mg) will experience GI side effects, which is expected since alli (orlistat 60 mg) works by inhibiting about 25% of dietary fat. alli (orlistat 60 mg) 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 (orlistat 60 mg) . 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 (orlistat 60 mg) as directed and sticking with a reduced-calorie, low-fat diet. The alli (orlistat 60 mg) starter pack includes portable reference guides and online support at myalli (orlistat 60 mg) .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 (orlistat 60 mg) if they have had an organ transplant or if they are taking medicine to reduce organ rejection.

alli™ (orlistat 60 mg) 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 (orlistat 60 mg) if taking cyclosporine; alli (orlistat 60 mg) can reduce levels of cyclosporine in the blood.

Patients on warfarin should talk with their doctor before taking alli (orlistat 60 mg) ; 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 (orlistat 60 mg) .

alli (orlistat 60 mg) 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 (orlistat 60 mg) 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.

Organ transplant alert:

Do not use if you have had an organ transplant. alli (orlistat 60 mg) interferes with the medicines used to prevent transplant rejection.

Allergy alert:

Do not use if you are allergic to any of the ingredients in alli (orlistat 60 mg) capsules.

DO NOT USE;

• if you are taking cyclosporine
• if you have been diagnosed with problems absorbing food
• if you are not overweight

Ask a doctor before use if you have ever had:

• gallbladder problems
• kidney stones
• pancreatitis

Precautions

Ask a doctor or pharmacist before use if you are

• taking warfarin (blood thinning medicine), or taking medicine for diabetes or thyroid disease. Your medication dose may need to be adjusted.
• taking other weight loss products.

When using this product

• take a multivitamin containing vitamins A, D, E, K, and beta-carotene once daily at bedtime is recommended. Orlistat inhibits 25% of dietary fat, and may reduce the absorption of some fat-soluble vitamins. alli (orlistat 60 mg) and a multivitamin should not be taken at the same time to gain the most benefit of a multivitamin. However, if they are taken at the same time, at least 70% of the fat-soluble vitamins would be absorbed.
• follow a well-balanced, reduced-calorie, low-fat diet. Try starting this diet before taking alli (orlistat 60 mg) capsules.
• alli (orlistat 60 mg) capsules work by preventing the absorption of some of the fat you eat. The fat passes out of your body so you may have bowel changes. You may get:
  • gas with oily spotting
  • loose stools
  • more frequent stools that may be hard to control

Eating a low-fat diet lowers the chance of having these bowel changes.

For every 5 pounds you lose from diet alone, alli (orlistat 60 mg) can help you lose 2-3 pounds more. In studies, most people lost 5-10 pounds over 6 months.

Stop use and ask a doctor if severe or continuous abdominal pain occurs. This may be a sign of a serious medical condition.

If pregnant or breast-feeding, do not use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if an individual has been diagnosed with problems absorbing food or is allergic to any of the ingredients in an alli (orlistat 60 mg) capsule.

Do not use if not overweight.

No information provided.

Contraindications

alli (orlistat 60 mg) is contraindicated in patients who have had an organ transplant or are taking medicine to reduce organ rejection, patients who are taking cyclosporine, and in patients with known problems absorbing food or are allergic to any of the ingredients in an alli (orlistat 60 mg) capsule.

No information provided