The active ingredient in alli (orlistat) has been used in the United States as a prescription-only medication at double the dose found in alli. 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 support program, called myalliplan. The myalliplan 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. The myalliplan.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 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 is different than Xenical® because it offers informational materials with the actual product. The alli starter pack includes over 200 pages of free in-pack materials to help guide individuals through the alli 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 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 to Xenical® is the manageability and tolerability of GI events. In clinical studies, the 60-mg capsule of alli 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, 81% of study participants reported being satisfied or very satisfied with orlistat, and 91% reported losing weight. In addition, alli 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 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, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, talc, titanium dioxide.

Last updated on RxList: 6/20/2007

alli™ 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. Check with your doctor before starting any exercise program.

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

The recommended dose of alli 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, continue with a diet and exercise program. If you start to regain weight after you stop taking alli, you may need to start taking alli again along with your diet and exercise program.

Take a multivitamin once a day, at bedtime, when using alli capsules.

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

Alli, MyAlli.com, MyAlliPlan.com, Alli 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

Last updated on RxList: 6/20/2007

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.

Last updated on RxList: 6/20/2007

Organ transplant alert:

Do not use if you have had an organ transplant. alli 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 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

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 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 capsules.
• alli 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 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 capsule.

Do not use if not overweight.

Last updated on RxList: 6/20/2007

No information provided.

alli 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 capsule.

Last updated on RxList: 6/20/2007

No information provided

Last updated on RxList: 6/20/2007

The alli program

The alli program is a comprehensive approach to weight loss. Combining the only FDA approved, over-the-counter weight loss product, alli, combined with an online action plan, the alli program brings together effective medical therapy and strong behavioral support. The alli 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™ starter pack you'll find:

• alli weight loss capsules
  
  The 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 Shuttle™
  
  The Shuttle™ makes it easy to carry the alli 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 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 booklets
  
  The booklets to help you follow the alli program. Check out the alli "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.



• myalliplan online guidance
  
  Losing weight takes effort and commitment. That's why the alli program includes an individually tailored online action plan. And it's free with your purchase of alli. 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 work?
A. As part of an overall weight loss program, alli works in conjunction with behavior modification to achieve a calorie balance that is both nutritionally sound and conducive to weight reduction.

alli 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 enables it to bind to and inactivate some GI lipases, which aid in the digestion of dietary fats (triglycerides). alli 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 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?
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 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. Lastly, these individuals will make the time to be more physically active.

Q. How is alli different from other weight loss products available?
A. alli is the only FDA approved, over-the-counter weight loss product. It combines a pill (alli 60 mg orlistat) with an individually tailored, online action plan based on sound clinical practices and designed by nutritional and weight loss experts. alli 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 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 support program, called myalliplan. The myalliplan 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. The myalliplan.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 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 is different than Xenical® because it offers informational materials with the actual product. The alli starter pack includes over 200 pages of free in-pack materials to help guide individuals through the alli 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 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 to Xenical® is the manageability and tolerability of GI events. In clinical studies, the 60-mg capsule of alli 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, 81% of study participants reported being satisfied or very satisfied with orlistat and 91% reported losing weight. In addition, alli 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 program. alli is not a program for everyone; without a commitment to adopting healthy habits, patients will not achieve their weight loss goals.

Last updated on RxList: 6/20/2007

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

ORLISTAT - ORAL

(OR-lih-stat)

COMMON BRAND NAME(S): Xenical

USES: This medication is used along with a doctor-approved reduced-calorie diet, exercise, and behavior modification program to help significantly overweight (obese) persons lose weight. Taking orlistat can also help prevent you from regaining the weight you have lost. Losing weight and keeping it off can reduce the many health risks that come with obesity, including heart disease, diabetes, high blood pressure, some forms of cancer, certain breathing problems, and a shorter lifespan.

Dietary fats need to be broken down into smaller pieces before the body can absorb them. Orlistat works by blocking the enzyme that breaks down fats in your diet. This undigested fat then passes out of your body in your bowel movement. Orlistat does not block the absorption of calories from sugar and other non-fat foods, so you still need to restrict your total intake of calories.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start taking orlistat and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth with liquid sometime during each main meal that contains fat or within 1 hour after the meal, usually 3 times daily or as directed by your doctor. If you occasionally miss a meal or your meal contains no fat, skip that dose of the medication. To decrease the chance of unpleasant side effects, it is very important that no more than 30% of the calories in your diet come from fat. Your daily intake of fat, protein, and carbohydrate should be evenly spread over 3 main meals.

Because this drug can interfere with the absorption of certain vitamins (fat-soluble vitamins including A, D, E, K), a daily multivitamin supplement containing these nutrients is recommended. Take the multivitamin at least 2 hours before or 2 hours after taking orlistat (e.g., at bedtime).

If you take cyclosporine, take it at least 2 hours before or after orlistat to make sure the full dose of cyclosporine is absorbed into your bloodstream. If you take levothyroxine, take it at least 4 hours before or after orlistat.

You should see some weight loss within 2 weeks after you start orlistat. Tell your doctor if your condition does not improve or if it worsens.

SIDE EFFECTS: Changes in your bowel function frequently occur because of the unabsorbed fat. Fatty/oily stool, oily spotting, intestinal gas with discharge, a feeling of needing to have a bowel movement right away, increased number of bowel movements, or poor bowel control may occur. These side effects may get worse if you eat more fat than you should. If these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking orlistat, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain digestive problem (chronic malabsorption syndrome), certain gall bladder problem (cholestasis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: underactive thyroid (hypothyroidism), kidney stones/problems (e.g., calcium oxalate kidney stones, hyperoxaluria), certain eating disorders (anorexia nervosa/bulimia).

If you are diabetic, weight loss may improve your blood sugar control. Be sure to check your blood sugar regularly and tell your doctor the results. Your diet or medications may need to be adjusted.

This medication is not recommended for use during pregnancy. Consult your doctor for more details.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also How to Use section.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.

Tell your doctor of all prescription and nonprescription medication you use, especially of: "blood thinners" (e.g., warfarin), cyclosporine, drugs for diabetes (e.g., glyburide, insulin, metformin).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others.

For best results, this medication should be used along with a doctor-approved exercise program and diet plan. Consult your doctor or dietician for help designing an appropriate exercise and food plan for you.

MISSED DOSE: If you miss a dose, take it as soon as you remember unless it has been more than 1-2 hours since your meal. In that case, skip the missed dose since most of the fat from your meal will already be absorbed and the medication will not work. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised September 2008 Copyright(c) 2008 First DataBank, Inc.