Xenical

Orlistat comes as a capsule and a nonprescription capsule to take by mouth. It is usually taken three times a day with each main meal that contains fat. Take orlistat during a meal or up to 1 hour after a meal. If a meal is missed or does not have fat, you may skip your dose. Follow the directions on your prescription label or the package label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take orlistat exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor or stated on the package.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient if orlistat is prescribed for you. For additional information about the nonprescription product, visit http://www.MyAlli.com.

Pregnancy Category: X; weight loss offers no potential benefit to a pregnant woman and may result in fetal harm; a minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese

Lactation: Not recommended; not known if orlistat is distributed in breast milk

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Oral Administration

Take with each fat-containing meal (during or up to 1 hr after the meal)

The patient should be on a nutritionally balanced, reduced-calorie diet that contains ~30% of calories from fat

Daily intake of fat, carbohydrate, and protein should be distributed over 3 main meals

If a meal is occasionally missed or contains no fat, omit the orlistat dose

You should use Xenical together with a nutritionally balanced, mildly reduced-calorie diet that contains no more than about 30% of calories from fat.

Read all food labels and avoid foods that have more than 30% fat.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Xenical is excreted in human breast milk or if it will harm your nursing baby.

• Xenical comes as a capsule to be taken with liquid at each main meal that contains fat.
• You can take Xenical in conjunction with a mildly reduced-calorie diet up to 3 times a day.
• Each time you take Xenical, your meal should contain no more than about 30% of calories from fat. 
• Take Xenical during meals or up to one hour after a meal. If you occasionally miss a meal or have a meal without fat, you can omit your dose of Xenical. 
• You should use Xenical together with a nutritionally balanced, mildly reduced-calorie diet that contains no more than about 30% of calories from fat. 
• You should evenly divide your daily intake of fat, carbohydrates, and protein over 3 main meals.
• You should try to follow a healthy eating plan such as the one developed by the American Heart Association. 
• Following this eating plan will help you lose weight while decreasing some of the possible gastrointestinal effects you may experience while taking Xenical.

Specific Drugs

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Xenical is contraindicated in:

• Pregnancy [see Use in Specific Populations (8.1)]
• Patients with chronic malabsorption syndrome
• Patients with cholestasis
• Patients with known hypersensitivity to Xenical or to any component of this product

Pregnancy

Pregnancy Category X

Xenical is contraindicated during pregnancy, because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy. No embryotoxicity or teratogenicity was seen in animals that received orlistat at doses much higher than the recommended human dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard of maternal weight loss to the fetus.

Animal Data

Reproduction studies were conducted in rats and rabbits at doses up to 800 mg/kg/day. Neither study showed embryotoxicity or teratogenicity. This dose is 23 and 47 times the daily human dose calculated on a body surface area (mg/m2) basis for rats and rabbits, respectively.

Nursing Mothers

It is not known if Xenical is present in human milk. Caution should be exercised when Xenical is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 have not been established.

The safety and efficacy of Xenical have been evaluated in obese adolescent patients aged 12 to 16 years. Use of Xenical in this age group is supported by evidence from adequate and well-controlled studies of Xenical in adults with additional data from a 54-week efficacy and safety study and a 21-day mineral balance study in obese adolescent patients aged 12 to 16 years. Patients treated with Xenical in the 54-week efficacy and safety study (64.8% female, 75% Caucasians, 18.8% Blacks, and 6.3% Other) had a mean reduction in BMI of 0.55 kg/m2 compared with an average increase of 0.31 kg/m2 in placebo-treated patients (p=0.001). In both adolescent studies, adverse effects were generally similar to those described in adults and included fatty/oily stool, oily spotting, and oily evacuation. In a subgroup of 152 Xenical and 77 placebo patients from the 54-week study, changes in body composition measured by DEXA were similar in both treatment groups with the exception of fat mass, which was significantly reduced in patients treated with Xenical compared to patients treated with placebo (-2.5 kg vs -0.6 kg, p=0.033). Because Xenical can interfere with the absorption of fat-soluble vitamins, all patients should take a daily multivitamin that contains vitamins A, D, E, K, and beta-carotene. The vitamin supplement should be taken at least 2 hours before or after Xenical [see Dosage and Administration (2), Warnings and Precautions (5.1), and Clinical Pharmacology (12.3)].

Plasma concentrations of orlistat and its metabolites M1 and M3 were similar to those found in adults at the same dose level. Daily fecal fat excretions were 27% and 7% of dietary intake in Xenical and placebo treatment groups, respectively.

Geriatric Use

Clinical studies of Xenical did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients [see Clinical Studies (14)].

Ask a doctor or pharmacist if it is safe for you to use Xenical if you are also using any of the following drugs:

• amiodarone;

• insulin or oral diabetes medicine;

• HIV or AIDS medications;

• seizure medicine (especially if your seizures get worse while taking orlistat);

• a vitamin or mineral supplement that contains beta-carotene or vitamin E; or

• a blood thinner - warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may interact with orlistat, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Common side effects of Xenical include: bowel urgency, frequent bowel movements, oily evacuation, oily rectal leakage, steatorrhea, and flatulence with discharge. Other side effects include: fecal incontinence. See below for a comprehensive list of adverse effects.