XENICAL- orlistat capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ORLISTAT (UNII: 95M8R751W8) (ORLISTAT - UNII:95M8R751W8)

Available from:

H2-Pharma LLC

INN (International Name):

ORLISTAT

Composition:

ORLISTAT 120 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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/m 2 or ≥27 kg/m 2 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. 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 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/m 2 ) basis for rats and rabbits, respectively. It is not known if XENICAL is present in human milk. Caution should be exercised when XENICAL is administered to a nursing woman. 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/m 2 compared with an average increase of 0.31 kg/m 2 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. 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)] . As with any weight-loss agent, the potential exists for abuse of XENICAL in inappropriate patient populations (e.g., patients with anorexia nervosa or bulimia). See Indications and Usage (1) for recommended prescribing guidelines.

Product summary:

XENICAL is a turquoise, hard-gelatin capsule containing pellets of powder. XENICAL 120 mg Capsules: Turquoise, two-piece, No. 1 opaque hard-gelatin capsule imprinted with XENICAL 120 in black ink — bottle of 90 (NDC 61269-460-90). 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.

Authorization status:

New Drug Application

Summary of Product characteristics

XENICAL- ORLISTAT CAPSULE
H2-PHARMA LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
XENICAL SAFELY AND
EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR XENICAL.
XENICAL (ORLISTAT) CAPSULES FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Warnings and Precautions, Oxalate Nephrolithiasis and Oxalate
Nephropathy with Renal Failure ( 5.3)
11/2022
INDICATIONS AND USAGE
XENICAL is a reversible inhibitor of gastrointestinal lipases
indicated for obesity management including
weight loss and weight maintenance when used in conjunction with a
reduced-calorie diet. ( 1)
XENICAL is also indicated to reduce the risk for weight regain after
prior weight loss. ( 1)
DOSAGE AND ADMINISTRATION
One 120-mg capsule three times a day with each main meal containing
fat (during or up to 1 hour after
the meal). ( 2)
Advise patients to take a nutritionally balanced, reduced-calorie diet
that contains approximately 30%
of calories from fat. ( 2)
Distribute the daily intake of fat, carbohydrate, and protein over
three main meals. ( 2)
Advise patients to take a multivitamin containing fat-soluble vitamins
to ensure adequate nutrition. ( 2)
Take the vitamin supplement at least 2 hours before or after the
administration of XENICAL, such as at
bedtime. ( 2)
For patients receiving both XENICAL and cyclosporine therapy,
administer cyclosporine 3 hours after
XENICAL. ( 2)
For patients receiving both XENICAL and levothyroxine therapy,
administer levothyroxine and XENICAL
at least 4 hours apart. ( 2)
DOSAGE FORMS AND STRENGTHS
Capsules: 120 mg. ( 3)
CONTRAINDICATIONS
Pregnancy ( 4, 8.1)
Chronic malabsorption syndrome ( 4)
Cholestasis ( 4)
Known hypersensitivity to XENICAL or to any component of this product
( 4)
WARNINGS AND PRECAUTIONS
XENICAL has drug interactions and can decrease vitamin absorption. (
5.1, 7)
Take a multivitamin supplement that contains fat-soluble vitamins to
ensure adequate nutrition. ( 5.1)
Rare cases of severe liver injury with hepatocellula