"Nov. 9, 2011 -- The FDA is again considering approval of an experimental weight loss drug it rejected a year ago over concerns about potential heart problems and birth defects in babies born to women who take the drug.
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 for weight regain after prior weight loss. XENICAL 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 (e.g., hypertension, diabetes, dyslipidemia).
Table 1 illustrates body mass index (BMI) according to a variety of weights and heights. The BMI is calculated by dividing weight in kilograms by height in meters squared. For example, a person who weighs 180 lbs and is 5'5” would have a BMI of 30.
Table 1 Body Mass Index (BMI), kg/m²*
Weight in lbs ÷ 2.2 = weight in kilograms (kg)
Height in inches × 0.0254 = height in meters (m)
1 foot = 12 inches
DOSAGE AND ADMINISTRATION
The recommended dose of XENICAL is one 120-mg capsule three times a day 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.
Because XENICAL has been shown to reduce the absorption of some fat-soluble vitamins and beta-carotene, patients should be counseled to take a multivitamin containing fat-soluble vitamins to ensure adequate nutrition [see WARNINGS AND PRECAUTIONS]. The vitamin supplement should be taken at least 2 hours before or after the administration of XENICAL, such as at bedtime.
For patients receiving both XENICAL and cyclosporine therapy, administer cyclosporine 3 hours after XENICAL.
For patients receiving both XENICAL and levothyroxine therapy, administer levothyroxine and XENICAL at least 4 hours apart. Patients treated concomitantly with XENICAL and levothyroxine should be monitored for changes in thyroid function.
Doses above 120 mg three times a day have not been shown to provide additional benefit.
Based on fecal fat measurements, the effect of XENICAL is seen as soon as 24 to 48 hours after dosing. Upon discontinuation of therapy, fecal fat content usually returns to pretreatment levels within 48 to 72 hours.
Dosage Forms And Strengths
XENICAL 120 mg dark-blue capsules imprinted with Roche and XENICAL 120 in light-blue ink or turquoise capsules imprinted with ROCHE and XENICAL 120 in black ink.
XENICAL is a dark-blue or turquoise, 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 (NDC 0004-0256-52).
XENICAL 120 mg Capsules: Turquoise, two-piece, No. 1 opaque hard-gelatin capsule imprinted with ROCHE and XENICAL 120 in black ink — bottle of 90 (NDC 0004-0257-52).
Storage And Handling
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.
XENICAL should not be used after the given expiration date.
Distributed by: Genentech US, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080- 4990. PPI Revised: 10/2013
Prescribing Document Revised: October 2013This monograph has been modified to include the generic and brand name in many instances.
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