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XENICAL (ORLISTAT) CAPSULES: PRESCRIBING INFORMATION

DESCRIPTION

Xenical (Orlistat) is a lipase inhibitor for obesity management that acts by inhibiting the absorption of dietary fats.

Orlistat is (S)-2-formylamino-4-methyl-pentanoic acid (S)-1-[[(2S, 3S)-3-hexyl-4-oxo-2-oxetanyl] methyl]-dodecyl ester. Its empirical formula is C29H53NO5, and its molecular weight is 495.7. It is a single diastereomeric molecule that contains four chiral centers, with a negative optical rotation in ethanol at 529 nm.

Orlistat is a white to off-white crystalline powder. Orlistat is practically insoluble in water, freely soluble in chloroform, and very soluble in methanol and ethanol. Orlistat has no pK a within the physiological pH range.

Xenical is available for oral administration in dark-blue, hard-gelatin capsules, with light-blue imprinting. Each capsule contains 120 mg of the active ingredient, orlistat. The capsules also contain the inactive ingredients sodium starch glycolate, microcrystalline cellulose, sodium lauryl sulfate, povidone, and talc. Each capsule shell contains gelatin, titanium dioxide, and FD&C Blue No.1, with printing of pharmaceutical glaze NF, titanium dioxide, and FD&C Blue No.1 aluminum lake.


CLINICAL PHARMACOLOGY

Xenical clinical pharmacology


PHARMACOKINETICS

Xenical pharmacokinetics


CLINICAL STUDIES

Xenical clinical studies


CLINICAL STUDIES: ONE-YEAR RESULTS

Xenical clinical studies: one-year results


CLINICAL STUDIES: TWO-YEAR RESULTS

Xenical clinical studies: two-year results


CLINICAL STUDIES: PATIENTS WITH TYPE 2 DIABETES

Xenical clinical studies: patients with type 2 diabetes


INDICATIONS AND USAGE

Orlistat (Xenical) capsules are 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 for weight regain after prior weight loss. This medication is indicated for obese patients with an initial body mass index (BMI) >= 30 kg/m2 or >= 27 kg/m2 in the presence of other risk factors (eg, hypertension, diabetes, dyslipidemia).


CONTRAINDICATIONS

Xenical capsules are contraindicated in patients with chronic malabsorption syndrome or cholestasis, and in patients with known hypersensitivity to Xenical or to any component of this product.


WARNINGS

Miscellaneous

Organic causes of obesity (eg, hypothyroidism) should be excluded before prescribing Xenical.

Preliminary data from a Xenical (Orlistat) and cyclosporine drug interaction study indicate a reduction in cyclosporine plasma levels when Xenical was coadministered with cyclosporine. Therefore, Xenical (Orlistat) capsules and cyclosporine should not be coadministered. To reduce the chance of a drug-drug interaction, cyclosporine should be taken at least 2 hours before or after Xenical in patients taking both drugs. In addition, in those patients whose cyclosporine levels are being measured, more frequent monitoring should be considered.


PRECAUTIONS

Xenical precautions


DRUG INTERACTIONS

Xenical drug interactions


NONCLINICAL TOXICOLOGY

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies in rats and mice did not show a carcinogenic potential for orlistat at doses up to 1000 mg/kg/day and 1500 mg/kg/day, respectively. For mice and rats, these doses are 38 and 46 times the daily human dose calculated on an area under concentration vs time curve basis of total drug-related material.

Orlistat (Xenical) pills have no detectable mutagenic or genotoxic activity as determined by the Ames test, a mammalian forward mutation assay (V79/HPRT), an in vitro clastogenesis assay in peripheral human lymphocytes, an unscheduled DNA synthesis assay (UDS) in rat hepatocytes in culture, and an in vivo mouse micronucleus test.

When given to rats at a dose of 400 mg/kg/day in a fertility and reproduction study, orlistat had no observable adverse effects. This dose is 12 times the daily human dose calculated on a body surface area (mg/m2) basis.


USE IN SPECIFIC POPULATIONS

Xenical use in specific populations


ADVERSE REACTIONS

Xenical adverse reactions


OVERDOSAGE

Single doses of 800 mg Xenical and multiple doses of up to 400 mg three times a day for 15 days have been studied in normal weight and obese subjects without significant adverse findings.

Should a significant overdose of Xenical (Orlistat) capsules occur, it is recommended that the patient be observed for 24 hours. Based on human and animal studies, systemic effects attributable to the lipase-inhibiting properties of orlistat should be rapidly reversible.


DOSAGE AND ADMINISTRATION

Xenical dosage and administration


HOW SUPPLIED

Xenical is a dark-blue, hard-gelatin capsule containing pellets of powder.

Xenical 120 mg capsules: dark-blue, two-piece, No. 1 opaque hard-gelatin capsule imprinted with Roche and XENICAL 120 in light-blue ink - bottle of 90.

Storage Conditions

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep bottle tightly closed.

Orlistat (Xenical) pills should not be used after the given expiration date.

Manufactured and distributed by Roche pharmaceutical company and its divisions.

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