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XENICAL.com -- Frequently Asked Questions About XENICAL Frequently Asked Questions About XENICAL

How effective is XENICAL?

What are the serious side effects of XENICAL?

How thoroughly has XENICAL been tested?

What is the difference between XENICAL and other weight-loss medications?

How do I know if I'm ready for XENICAL?

Who should not use XENICAL?

What should I tell my doctor before taking XENICAL?

Can I take XENICAL with other medications?

Should I take a multivitamin with XENICAL?

How long should I use XENICAL?

If XENICAL works only on the fat in the foods I've eaten, how do I lose the fat on my body?

If I take XENICAL, can I eat whatever I want?

What happens if I miss a dose or take more than the recommended dose?

How soon after starting XENICAL should I expect to notice weight loss?

How much weight should I expect to lose?

What are the common side effects of XENICAL?

I've been taking XENICAL for 2 weeks, but I haven't seen any weight loss yet. What am I doing wrong?

I'm still following the XENICAL plan, but I've stopped losing weight. Why?


How effective is XENICAL?
In clinical studies, people treated with XENICAL and a reduced-calorie diet with no more than 30% of calories from fat achieved significantly greater weight loss than people who were treated with diet alone.

The studies were designed with all participants eating a reduced-calorie diet for 4 weeks, followed by the diet plus XENICAL or the diet alone for 52 weeks. After 52 weeks, those taking XENICAL plus diet lost an average of twice as much weight as those who used the diet alone (approximately 13.4 lbs versus 5.8 lbs).

There is clear scientific evidence that if you are overweight, losing as little as 5% to 10% of your body weight can result in improved health. In studies of XENICAL, almost 40% of people treated with XENICAL plus diet successfully lost at least 5% of their body weight after 2 years. In comparison, 24% of the people treated with diet alone managed to lose 5% of their weight.

Weight loss with XENICAL and a healthy diet also improves a number of weight-related health risks. Studies show that weight loss with XENICAL can:
  • Decrease total and LDL cholesterol (level of low-density lipoprotein-also known as bad cholesterol) total: -2.0% XENICAL vs. +5.0% placebo, LDL: -4.0% vs. +5.0%
  • Improve ratio of bad to good cholesterol (LDL/HDL cholesterol): -0.37 XENICAL vs. -0.20 placebo
  • Reduce blood pressure: systoslic -1.01 vs +0.58 mmHg, diastolic -1.19 vs +0.46 mmHg
  • Reduce levels of insulin (hormone that allows glucose or sugar to enter the body's cells), high levels of which are associated with coronary heart disease: -6.7 vs +5.2 pmol/L
  • Reduce the risk or delay the progression to type 2 diabetes in patients: incidence rate of 5.5% for XENICAL vs 8.3% for placebo
Note: The long-term benefits of XENICAL on weight-related illnesses and life expectancy have not been studied.
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What are the serious side effects of XENICAL?
  • Lowered absorption of certain vitamins in your body. Take a multivitamin containing vitamins A, D, E, K, and beta-carotene one time each day. Take a multivitamin at least 2 hours before or after you take XENICAL, such as at bedtime.
  • Severe liver problems. Stop taking XENICAL and call your doctor right away if you have the following symptoms of liver problems:
    • loss of appetite
    • itchy skin
    • yellowing of your skin or the white part of your eyes
    • amber-colored urine
    • light-colored bowel movements (stools)
    • pain in the upper right portion of your stomach
  • Kidney problems. Your doctor may do certain tests to check your kidney function during treatment with XENICAL. Call your doctor right away if you have the following symptoms of kidney problems:
    • swelling, especially of the legs and feet
    • little or no urine output
    • frequent or painful urination
    • blood in the urine
    • loss of appetite, nausea and vomiting
    • severe pain in the back, belly or groin
  • Gallbladder problems (gallstones). Call your doctor right away if you have the following symptoms of gallstones:
    • pain in the upper right portion of your stomach
    • nausea
    • vomiting

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How thoroughly has XENICAL been tested?
The effects of XENICAL on weight loss, weight maintenance and weight regain, as well as the effects of weight loss with XENICAL on other weight-related health problems (such as type 2 diabetes, high cholesterol levels and high blood pressure), have been assessed in a 4-year diabetes-prevention study and in seven 1-to-2-year, multicenter, double-blind, placebo-controlled clinical trials. These studies included more than 7100 patients.
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What is the difference between XENICAL and other weight-loss medications?
There are typically two different kinds of weight-loss prescription medications. Some medications are appetite suppressants. Xenical is another form of weight-loss medication that works in your digestive system to block about one third of the fat in the food you eat from being digested. Check out What Does XENICAL Do? for a demonstration of how XENICAL works.
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How do I know if I'm ready for XENICAL?
To use XENICAL properly you must be committed to:
  • Talking with your doctor.
  • Following the proper medication schedule.
  • Eating a reduced-calorie diet with no more than 30% of calories from fat.
  • Monitoring your food intake.
  • Taking a multivitamin every day.
  • Setting realistic, achievable weight-loss goals you can feel good about.
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Who should not use XENICAL?
Do not take Xenical if you
  • are pregnant. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese.
  • have food absorption problems (chronic malabsorption syndrome)
  • have gallbladder problems (cholestasis)
  • are allergic to orlistat or any of the ingredients in XENICAL

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What should I tell my doctor before taking XENICAL?
Before you take XENICAL, tell your doctor if you:
  • have liver problems
  • have kidney problems
  • have problems with your thyroid
  • have eating problems such as anorexia or bulimia
  • have diabetes
  • are breastfeeding or plan to breastfeed. It is not known if XENICAL passes into your breast milk. Talk to your doctor before you breastfeed and take XENICAL.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

XENICAL and other medicines may affect each other causing side effects. XENICAL may affect the way other medicines work, and other medicines may affect the way XENICAL works.

Especially tell your doctor if you are taking:
  • cyclosporine (Gengraf, Neoral, Sandimmune, Restasis, Sangcya)
  • beta-carotene or vitamin E supplements
  • levothyroxine (Levo-T, Levolet, Levothyroid, Levothyroxine Sodium, Levoxyl, Novothyrox, Synthroid, Tirosint, Unithroid)
  • warfarin (Athrombin, Athrombin-K, Coumadin, Jantoven, Panwarfin, Warfarin Sodium)
Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.
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Can I take XENICAL with other medications?
Discuss with your doctor all medications you are currently taking (including over-the-counter medicines and herbal products you can get without a prescription) to determine if XENICAL can be taken along with these medications. If you are taking cyclosporine or thyroxine, let your doctor know before taking XENICAL; cyclosporine and XENICAL should be taken at least 2 hours apart. If your cyclosporine levels are being measured, more-frequent measurements may be necessary while you're taking XENICAL. Levothyroxine and XENICAL should be taken at least 4 hours apart.
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Should I take a multivitamin with XENICAL?
Because XENICAL interferes with your body's absorption of some fat-soluble vitamins, you should take a daily multivitamin supplement that contains vitamins A, D, E and K and beta carotene once a day at least 2 hours before or after taking XENICAL, such as at bedtime.
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How long should I use XENICAL?
The use of XENICAL for more than 4 years has not been studied. You and your doctor should discuss how long you should use XENICAL.
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If XENICAL works only on the fat in the foods I've eaten, how do I lose the fat on my body?
By consuming fewer calories, your body will automatically tap into its fat stores and use them for the energy it needs.
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If I take XENICAL, can I eat whatever I want?
The XENICAL dietary guidelines do not place any particular food out of bounds. But you may not be able to eat a lot of a particular food if it is high in calories or, especially, if it is high in fat.
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What happens if I miss a dose or take more than the recommended dose?
If you miss a dose, you simply lose the potential benefit of XENICAL in blocking one third of the fat in the food you eat at that meal. Simply resume taking XENICAL at your next meal containing fat. In clinical trials, taking additional doses of XENICAL did not improve weight loss.
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How soon after starting XENICAL should I expect to notice weight loss?
Typically, people begin losing weight within 2 weeks of starting XENICAL, and may continue to lose weight for 6 to 12 months, at which point weight loss usually begins to level off -- even if you're still taking XENICAL. This doesn't mean that XENICAL is not working. People who continue to take XENICAL are better able to maintain their weight loss. Keep your doctor informed about your progress so that he or she can make sure your diet and your level of physical activity remain appropriate to your weight-loss goals. Once you reach your initial goal, you may want to set a new goal and have your doctor re-evaluate your calorie and activity levels.
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How much weight should I expect to lose?
The amount of weight you may lose may depend on how well you stick to a reduced-calorie diet with no more than 30% of calories from fat and an appropriate physical activity level, as well as on your compliance with the prescribed medication regimen. Individual results may vary.
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What are the common side effects of XENICAL?
The most common side effects of XENICAL include:
  • oily* rectal discharge
  • passing gas with oily discharge*
  • urgent need to have a bowel movement
  • oily* or fatty stools
  • increased number of bowel movements
  • being unable to control your bowel movements

  • *Oily discharge may be clear or have an orange or brown color.
These are not all the possible side effects of XENICAL. For more information, ask your doctor or pharmacist.



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I've been taking XENICAL for 2 weeks, but I haven't seen any weight loss yet. What am I doing wrong?
If you believe that you haven't lost any -- or enough -- weight, contact your doctor. He or she may need to readjust either the calorie restriction of your diet or your activity level. Your doctor may suggest that you maintain a Daily Diary to get an idea of how many calories and grams of fat you are actually consuming on a daily basis. If you have been keeping a food diary, be sure to show it to your doctor. Your doctor may also need to reevaluate if XENICAL is right for you.
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I'm still following the XENICAL plan, but I've stopped losing weight. Why?
This is known as plateauing or leveling off, and it's perfectly normal. However, you should let your doctor know; he or she may need to readjust your calorie restriction and/or your activity level.

To maintain your new weight, you'll need fewer calories than when you started the XENICAL program. As the body loses weight, it needs less energy, or calories. On the other hand, if you've been increasing your physical activity level, you might be building muscle and losing fat, thereby replacing weight from fat with weight from muscle.

Your doctor may ask you if you've seen any changes in your body measurements, such as that of your chest/breast, abdomen, waist and hips. If you've kept a monthly record of your body measurements, be sure to show this to your doctor. Your doctor may also need to reevaluate if XENICAL is right for you.
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Indication

XENICAL is a prescription medicine used with a low calorie diet to increase weight loss in people with obesity. XENICAL may help obese people lose weight and keep the weight off.

It is not known if XENICAL is safe and effective in children under 12 years old.


Important Safety Information

Do not take XENICAL if you:
  • are pregnant. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese.
  • have food absorption problems (chronic malabsorption syndrome)
  • have gallbladder problems (cholestasis)
  • are allergic to orlistat or any of the ingredients in XENICAL
Before you take XENICAL, tell your doctor if you:
  • have liver problems
  • have kidney problems
  • have problems with your thyroid
  • have eating problems such as anorexia or bulimia
  • have diabetes
  • are breastfeeding or plan to breastfeed. It is not known if XENICAL passes into your breast milk. Talk to your doctor before you breastfeed and take XENICAL.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you are taking:
  • cyclosporine (Gengraf, Neoral, Sandimmune, Restasis, Sangcya)
  • beta-carotene or vitamin E supplements
  • levothyroxine (Levo-T, Levolet, Levothyroid, Levothyroxine Sodium, Levoxyl, Novothyrox, Synthroid, Tirosint, Unithroid)
  • warfarin (Athrombin, Athrombin-K, Coumadin, Jantoven, Panwarfin, Warfarin Sodium)

XENICAL may cause serious side effects, including:
  • Lowered absorption of certain vitamins in your body. Take a multivitamin containing vitamins A, D, E, K, and beta-carotene one time each day. Take a multivitamin at least 2 hours before or after you take XENICAL, such as at bedtime.
  • Severe liver problems. Stop taking XENICAL and call your doctor right away if you have the following symptoms of liver problems:
    • loss of appetite
    • itchy skin
    • yellowing of your skin or the white part of your eyes
    • amber-colored urine
    • light-colored bowel movements (stools)
    • pain in the upper right portion of your stomach
  • Kidney problems. Your doctor may do certain tests to check your kidney function during treatment with XENICAL. Call your doctor right away if you have the following symptoms of kidney problems:
    • swelling, especially of the legs and feet
    • little or no urine output
    • frequent or painful urination
    • blood in the urine
    • loss of appetite, nausea and vomiting
    • severe pain in the back, belly or groin
  • Gallbladder problems (gallstones). Call your doctor right away if you have the following symptoms of gallstones:
    • pain in the upper right portion of your stomach
    • nausea
    • vomiting

The most common side effects of XENICAL include:
  • oily* rectal discharge
  • passing gas with oily discharge*
  • urgent need to have a bowel movement
  • oily* or fatty stools
  • increased number of bowel movements
  • being unable to control your bowel movements
*Oily discharge may be clear or have an orange or brown color.


How should I take XENICAL?
  • Take XENICAL exactly as your doctor tells you to take it.
  • Your doctor will tell you how much XENICAL to take and when to take it.
  • Take XENICAL with your meals or up to one hour after your meal. If you miss a meal or have a meal without fat, you can skip your dose of XENICAL. If you take a cyclosporine medicine, take XENICAL and cyclosporine at least 3 hours apart. See "What should I tell my doctor before taking XENICAL?" for a complete list of cyclosporine medicines.
  • If you take a multivitamin, take it at least 2 hours before or after you take XENICAL. Bedtime is a good time to take your multivitamin.
  • If you take a levothyroxine medicine, take XENICAL and levothyroxine at least 4 hours apart. See "What should I tell my doctor before taking XENICAL?" for a complete list of levothyroxine medicines.
  • If you take a cyclosporine medicine, take it at least 3 hours after you take XENICAL. See "What should I tell my doctor before taking XENICAL?"
Take XENICAL with a nutritionally balanced, low calorie diet that has no more than about 30% of calories from fat. Taking XENICAL with any meal high in fat (more than 30% fat) may make the common side effects worse.

If you take too much XENICAL call your doctor or go to the nearest hospital emergency room right away.

These are not all the possible side effects of XENICAL. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Click here for Important Patient Information.