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Product Information

* Indications

* Efficacy

* Contraindications and Warnings

* Precautions

* Adverse Events

* Dosage and Administration


Indications

XENICAL acts locally to inhibit GI lipases, blocking the
absorption of approximately 30% of dietary fat. XENICAL is
indicated for obesity management, including weight loss and weight
maintenance, when used in conjunction with a reduced-calorie diet.
XENICAL is also indicated to reduce the risk of weight regain
after prior weight loss. XENICAL is indicated for obese patients
with an initial BMI of >30 kg/m2 or >27 kg/m2 in the presence of
other risk factors, such as type 2 diabetes, hypertension and
dyslipidemia.

How XENICAL Works
How XENICAL Works

How fat blocking works

* XENICAL acts locally to inhibit the fat-digesting action of
lipases in the GI tract.

* Intact triglycerides pass through the intestines unabsorbed,
creating a caloric deficit.

* Absorption of carbohydrates and proteins is not affected.



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Efficacy

In clinical trials, XENICAL plus diet:

* Provided twice the mean weight loss as placebo plus diet

* Maintained mean weight loss better than placebo plus diet20,57

* Improved cardiovascular and metabolic risk factors better than
placebo plus diet20,28,57

XENICAL was evaluated in seven long-term studies (1 to 2 years'
duration) involving more than 4000 patients. XENICAL has proven
safety and tolerability profiles.

Year 1: Faster and greater weight loss 57

Year 1: Faster and greater weight loss

In one study, three times as many patients (25% on XENICAL plus
diet versus 8% on placebo plus diet, P<0.001) lost>10% of their
body weight from randomization (mean: 31 lbs; range: 18 to 67
lbs).18

In five studies:

* Two to five times as many patients on XENICAL plus diet lost
>10% of their body weight from randomization versus those on
placebo plus diet.

* Pooled data showed overall mean weight loss from randomization
was 13.4 lbs for XENICAL plus diet versus 5.8 lbs for placebo
plus diet.

Year 2: Significant weight loss maintained

Year 2: Percentage of patients losing >=10% and >=5% of body weight from randomization

In one study, almost four times as many patients on XENICAL plus
diet maintained a weight loss of >10% of their body weight from
randomization versus those on placebo plus diet.

In four studies:

* Two to five times as many patients on XENICAL plus diet
maintained a weight loss of >10% of their body weight from
randomization versus those on placebo plus diet.


Dyslipidemia

Sustained weight loss with improvement in cardiovascular risk
factors

LDL cholesterol: patients with LDL of >130 mg/dL at randomization

* At year 1, XENICAL plus diet was more effective in reducing
LDL cholesterol than placebo plus diet for any weight-loss
category.

Year 1: Mean change in LDL cholesterol in patients with LDL cholesterol >=130 mg/dL

* At year 1, the mean change from randomization in LDL
cholesterol was -7.8% for XENICAL plus diet versus +1.1% for
placebo plus diet (P<0.001).15

* For XENICAL plus diet, there was a consistent decline in LDL
cholesterol for 12 weeks following randomization, an
improvement that was maintained through week 52.

* In contrast, for placebo plus diet, mean LDL cholesterol
levels generally remained close to levels at randomization.

* At year 2, the improvements seen with XENICAL plus diet were
maintained (P<0.001).

In the population as a whole, including patients with normal LDL
at randomization:

* The mean change in LDL cholesterol at year 1 was -4.0% for
XENICAL plus diet and +5.0% for placebo plus diet (P<0.001).

The long-term effects of orlistat on morbidity and mortality
associated with obesity have not been established.

Hypertension

XENICAL plus diet improved both systolic and diastolic blood
pressures versus placebo plus diet.

Year 1: Mean change from randomization in patients with abnormal blood pressure

The long-term effects of orlistat on morbidity and mortality
associated with obesity have not been established.

Type 2 Diabetes

Efficacy and safety demonstrated in a 1-year study of obese type 2
diabetics on sulfonylureas (n=321) 28

Improved Glycemic Control -Year 1: Mean changes from randomization in sulfonylurea usage in type 2 diabetes patients

Significantly more patients on XENICAL plus diet reduced or
discontinued sulfonylurea usage versus those on placebo plus diet
(43.2% vs. 28.9%, P<0.05), with significantly greater reductions
in mean dosage (P<0.05).

Decrease in HbA1c in patients with HbA1c greater than 8%

The long-term effects of orlistat on morbidity and mortality
associated with obesity have not been established.

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Contraindications and Warnings

* XENICAL is contraindicated in patients with chronic
malabsorption syndrome or cholestasis (impaired bile flow),
and in patients with known hypersensitivity to XENICAL or to
any component of this product.

* Organic causes of obesity, such as hypothyroidism, should be
excluded before prescribing XENICAL.

* To reduce the chance of drug-drug interaction resulting in
reduced levels of cyclosporine, XENICAL and cyclosporine
should not be taken within 2 hours of each other.
More-frequent monitoring of cyclosporine levels should be
considered in patients taking both drugs.


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Precautions

Fat-Soluble Vitamins

When taking XENICAL, patients should be advised to take a
multivitamin supplement containing fat-soluble vitamins to ensure
adequate nutrition, because XENICAL has been shown to reduce the
absorption of some fat-soluble vitamins, including beta-carotene,
and because the status of obese patients in general and patients
on weight-control diets may be low. The supplement should be taken
once a day at least 2 hours before or after administration of
XENICAL, such as bedtime.

Toxicology

No evidence of bacterial or mammalian mutagenicity, unscheduled
DNA synthesis, chromosome aberrations or mouse micronuclei was
seen in bacterial and animal studies. No evidence of
carcinogenicity existed in animals with systemic exposure to
orlistat many times higher than that used in human studies.

Inappropriate Use

As with any weight-loss agent, the potential exists for misuse of
XENICAL in inappropriate patient populations (e.g., patients with
anorexia nervosa or bulimia). See recommended prescribing
guidelines for more detail.

Pregnancy Category B

XENICAL is not recommended for use during pregnancy.

Nursing Mothers

XENICAL should not be taken by nursing mothers.

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Adverse Events

Gastrointestinal symptoms are the most commonly observed
(incidence of 5% of more, and twice that of placebo) adverse
events associated with the use of XENICAL in the double-blind,
placebo-controlled clinical trials, and are primarily a
manifestation of the mechanism of action. The most common of these
adverse events were oily spotting, flatus with discharge, fecal
urgency, fatty/oily stool, oily evacuation, increased defecation
and fecal incontinence.

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Dosage and Administration

* The recommended dose of XENICAL is one 120-mg capsule 3 times
a day, once with each main meal containing fat (during or up
to 1 hour after the meal).

* The patient should be on a nutritionally balanced,
reduced-calorie diet that contains approximately 30% of
calories from fat. The daily intake of fat, carbohydrate and
protein should be distributed over three main meals. If a meal
is occasionally missed or contains no fat, the dose of XENICAL
can be omitted.

* Doses above 120 mg 3 times a day have not been shown to
provide additional benefit.

* The safety and effectiveness of XENICAL beyond 2 years have
not been determined at this time.


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Mechanism of Action

Physicians' FAQ

Managing Patients with Obesity-Related Comorbidities

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