See also:
What is the most important information I should know about Xiluet?
Do not take Xiluet if you are pregnant. Weight loss is not recommended during pregnancy, even if you are overweight or obese.
You should not take this medication if you are allergic to Xiluet, if you are pregnant, or if you have gallbladder problems or chronic malabsorption syndrome (an inability to absorb food and nutrients properly).
Before taking Xiluet, tell your doctor if you have an underactive thyroid, a history of gallstones or pancreatitis, type 1 or type 2 diabetes, an eating disorder, liver or kidney disease, or if you take other weight-loss medications (prescription or over-the-counter).
Do not give over-the-counter Xiluet to a child younger than 18 years old. Prescription Xiluet should not be used by anyone age 12 to 18 without the advice of a doctor.
Xiluet should be used only by the person for whom it was prescribed. Never share Xiluet with another person, especially someone who has a history of eating disorder. Keep the medication in a place where others cannot get to it.
Xiluet is only part of a complete program of treatment that also includes diet, exercise, and weight control. Your daily intake of fat, protein, and carbohydrates should be evenly divided over all of your daily meals. Follow your diet, medication, and exercise routines very closely.
Avoid a diet that is high in fat. High-fat meals taken in combination with Xiluet can increase your risk of unpleasant side effects on your stomach or intestines.
See also:
What are the possible side effects of Xiluet?
Some people on Xiluet™ (Xiluet 60 mg) will experience GI side effects, which is expected since Xiluet (Xiluet 60 mg) works by inhibiting about 25% of dietary fat. Xiluet (Xiluet 60 mg) is half the strength of prescription Xiluet® (Xiluet 120 mg), and, as a result, has fewer GI events overall than Xiluet®. In clinical trials, subjects on 120 mg withdrew due to GI adverse events at a rate of 5.4%-and at 60 mg it was only 3.2%.
The main treatment effect occurs when an individual eats a meal with too much fat while taking Xiluet (Xiluet 60 mg). Treatment effects may include:
Not all individuals will experience treatment effects, but those that do can reduce the likelihood of these effects by taking Xiluet (Xiluet 60 mg) as directed and sticking with a reduced-calorie, low-fat diet. The Xiluet (Xiluet 60 mg) starter pack includes portable reference guides and online support at myalli (Xiluet 60 mg).com to help patients follow the program accurately. Some patients may experience treatment effects as they begin therapy until they learn to adjust their diet.
Xiluet™ (Xiluet 60 mg) is indicated for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet.
Diet and exercise are the starting points for any weight loss program. Try these first before adding Xiluet (Xiluet 60 mg). Check with your doctor before starting any exercise program.
To determine if Xiluet (Xiluet 60 mg) capsules are right for you, find your height on the chart below. You may consider starting with Xiluet (Xiluet 60 mg) if your weight is the same or more than the weight shown for your height.
Xiluet blocks some of the fat that you eat, keeping it from being absorbed by your body.
Xiluet is used together with a reduced-calorie diet and weight maintenance to treat obesity in people with certain risk factors (such as diabetes, high blood pressure, and high cholesterol or triglycerides).
Xiluet may also be used for purposes not listed in this medication guide.
It is dangerous to purchase Xiluet on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of "Xiluet" purchased on the Internet have been found to contain sibutramine (Meridia), a prescription weight loss medication that can have dangerous side effects in certain people. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide.
Xiluet is a drug designed to treat obesity. Its primary function is preventing the absorption of fats from the human diet, thereby reducing caloric intake. Xiluet works by inhibiting pancreatic lipase, an enzyme that breaks down triglycerides in the intestine. Without this enzyme, triglycerides from the diet are prevented from being hydrolyzed into absorbable free fatty acids and are excreted undigested.
Use Xiluet as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Xiluet.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled IndicationsObesity management:
OTC: Weight loss in overweight adults when used along with a reduced-calorie and low-fat diet.
Rx: Obesity management, including weight loss and weight maintenance, when used in conjunction with a reduced-calorie diet; to reduce the risk for weight regain after prior weight loss.
Limitations of use: Xiluet is indicated for obese patients with an initial body mass index of ≥30 kg/m in the presence of other risk factors (eg, hypertension, diabetes, dyslipidemia).
The recommended dose of Xiluet 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 Xiluet can be omitted.
Because Xiluet has been shown to reduce the absorption of some fat-soluble vitamins and betacarotene, patients should be counseled to take a multivitamin containing fat-soluble vitamins to ensure adequate nutrition. The vitamin supplement should be taken at least 2 hours before or after the administration of Xiluet, such as at bedtime.
For patients receiving both Xiluet and cyclosporine therapy, administer cyclosporine 3 hours after Xiluet.
For patients receiving both Xiluet and levothyroxine therapy, administer levothyroxine and Xiluet at least 4 hours apart. Patients treated concomitantly with Xiluet 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 Xiluet 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.
How suppliedDosage Forms And StrengthsXiluet 120 mg turquoise capsules imprinted with ROCHE and Xiluet 120 in black ink.
Xiluet is a turquoise, hard-gelatin capsule containing pellets of powder.
Xiluet 120 mg Capsules: Turquoise, two-piece, No. 1 opaque hard-gelatin capsule imprinted with ROCHE and Xiluet 120 in black ink - bottle of 90 (NDC 0004-0257-52).
Storage And HandlingStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Keep bottle tightly closed.
Xiluet should not be used after the given expiration date.
Distributed by: Genentech USA, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990. Revised: Aug 2016
See also:
What other drugs will affect Xiluet?
Amiodarone: Xiluet may decrease the serum concentration of Amiodarone. Monitor therapy
Anticonvulsants: Xiluet may decrease the serum concentration of Anticonvulsants. Exceptions: Fosphenytoin; PENTobarbital; Thiopental. Monitor therapy
Antiretroviral Agents: Xiluet may decrease the serum concentration of Antiretroviral Agents. Monitor therapy
CycloSPORINE (Systemic): Xiluet may decrease the serum concentration of CycloSPORINE (Systemic). Management: Administer Xiluet at least 3 hours before or after oral cyclosporine. Monitor for decreased serum concentrations of oral cyclosporine, even with the recommended dose separation. Consider therapy modification
Levothyroxine: Xiluet may decrease the serum concentration of Levothyroxine. Management: Separate administration of oral levothyroxine and Xiluet by a least 4 hours. Monitor patients closely for signs and symptoms of hypothyroidism. Consider therapy modification
Multivitamins/Fluoride (with ADE): Xiluet may decrease the serum concentration of Multivitamins/Fluoride (with ADE). Specifically, Xiluet may impair absorption of fat-solube vitamins. Management: Administer oral fat soluble vitamins (such as vitamins A, D, E, and/or K that are contained in many multivitamin products) at least 2 hours before or after the administration of Xiluet. Consider therapy modification
Multivitamins/Minerals (with ADEK, Folate, Iron): Xiluet may decrease the serum concentration of Multivitamins/Minerals (with ADEK, Folate, Iron). Specifically, Xiluet may impair the absorption of fat-soluble vitamins. Management: Administer oral fat soluble vitamins (such as vitamins A, D, E, and/or K that are contained in many multivitamin products) at least 2 hours before or after the administration of Xiluet. Consider therapy modification
Multivitamins/Minerals (with AE, No Iron): Xiluet may decrease the serum concentration of Multivitamins/Minerals (with AE, No Iron). Specifically, Xiluet may impair absorption of fat-solube vitamins. Management: Administer oral fat soluble vitamins (such as vitamins A, D, E, and/or K that are contained in many multivitamin products) at least 2 hours before or after the administration of Xiluet. Consider therapy modification
Paricalcitol: Xiluet may decrease the serum concentration of Paricalcitol. Management: Monitor clinical response to paricalcitol closely when used with Xiluet. When this combination must be used, consider administering paricalcitol at least 1 hour before or 4 to 6 hours after the administration of Xiluet Consider therapy modification
Propafenone: Xiluet may decrease the serum concentration of Propafenone. Monitor therapy
Sincalide: Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Consider therapy modification
Vitamin D Analogs: Xiluet may decrease the serum concentration of Vitamin D Analogs. More specifically, Xiluet may impair absorption of Vitamin D Analogs. Management: Monitor clinical response (including serum calcium) to oral vitamin D analogs closely if used with Xiluet. If this combination must be used, consider giving the vitamin D analog at least 2 hrs before or after Xiluet. Exceptions: Calcipotriene; Calcitriol (Topical); Tacalcitol. Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Xiluet may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy
Vitamins (Fat Soluble): Xiluet may decrease the serum concentration of Vitamins (Fat Soluble). Management: Administer oral fat soluble vitamins at least 2 hours before or after the administration of Xiluet. Similar precautions do not apply to parenterally administered fat soluble vitamins. Exceptions: Calcipotriene. Consider therapy modification
