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Generic Name: Orlistat
Class: GI Drugs, Miscellaneous
ATC Class: A08AB01
VA Class: GA900
Chemical Name: [2S-[2α*),3β]]-1-[(3-hexyl-4-oxo-2-oxetanyl)-methyl]dodecyl-N-formyl-lLeucine
Molecular Formula: C29H53O5
CAS Number: 96829-58-2

Introduction

Reversible inhibitor of gastric and pancreatic lipases;1 2 4 5 6 8 9 10 11 12 13 14 18 19 21 22 47 51 exhibits antiobesity1 6 7 8 17 23 36 and antilipemic activity.1 3 4 5 6 7 8 20 36

Uses for Xenical

Obesity

Orlistat (e.g., Xenical) is used as an adjunct to caloric restriction, increased physical activity, and behavioral modification in the treatment of exogenous obesity; also used to reduce the risk of weight regain after initial loss.1 6 7 8 15 17 27 36

Use in patients with initial body mass index (BMI) of ≥30 kg/m2; also use in those with BMI of ≥27 kg/m2 in the presence of risk factor or disease (e.g., hypertension, diabetes mellitus, hyperlipidemia).1 15 27

Used as self-medication (e.g., Alli) to promote weight loss in overweight adults ≥18 years of age; use in conjunction with a reduced-calorie, low-fat diet.46

Xenical Dosage and Administration

Administration

Oral Administration

Administer orally 3 times daily, during (or up to 1 hour after) each main meal containing fat.1 8 19 20 23 27 46 47 However, efficacy apparently not affected by administering the drug up to 2 hours after midmeal.19 20

Omit orlistat dose if a meal occasionally is missed or contains no fat.1 27 47

Distribute daily intake of fat (30% of calories), carbohydrate, and protein over 3 main meals.1 27

Manufacturers recommend use of multivitamin supplement containing fat-soluble vitamins (A, D, E, K) and beta carotene.1 27 46 Administer multivitamin ≥2 hours before or after orlistat; may administer vitamin supplement at bedtime for convenience.1 8 27 37 46 (See Multivitamin Supplementation under Cautions.)

Dosage

Pediatric Patients

Obesity
Oral

Adolescents ≥12 years of age: 120 mg 3 times daily with each main meal containing fat.1 6 7 8 17 23 27 36 No additional benefit with dosages >120 mg 3 times daily.1 23

Reassess weight management and therapy periodically.1 7 27 39 Safety and efficacy beyond 4 years not established in clinical studies.1 7 27 39 However, if effective for weight loss or maintenance and no serious adverse effects occur, may continue orlistat as long as clinically indicated.17

Not approved for self-medication for weight loss in pediatric patients.46

Adults

Obesity
Oral

120 mg 3 times daily with each main meal containing fat.1 6 7 8 17 23 27 36 No additional benefit with dosages >120 mg 3 times daily.1 23

Reassess weight management and therapy periodically.1 7 27 39 Safety and efficacy beyond 4 years not established in clinical studies.1 7 27 39 However, if effective for weight loss or maintenance and no serious adverse effects occur, may continue orlistat as long as clinically indicated.17

For self-medication for weight loss (e.g., Alli), usual dosage is 60 mg 3 times daily with each main meal containing fat.46

Prescribing Limits

Pediatric Patients

Obesity
Oral

No additional benefit with dosages >120 mg 3 times daily.1 23

Adults

Obesity
Oral

No additional benefit with dosages >120 mg 3 times daily.1 23

For self-medication, do not exceed three 60-mg capsules daily.46

Cautions for Xenical

Contraindications

  • Chronic malabsorption syndrome or cholestasis.1 27

  • Known hypersensitivity to orlistat or any ingredient in the formulations.1 27 46

Warnings/Precautions

Warnings

Obesity Evaluation

Rule out organic causes of obesity (e.g., hypothyroidism) before initiating orlistat therapy.1

Cyclosporine Interaction

Do not administer concomitantly with cyclosporine; administer cyclosporine 2 hours before or after orlistat.1 (See Specific Drugs under Interactions.)

Organ transplant recipients should not use orlistat for self-medication because of possible interaction with immunosuppressive agents, including cyclosporine.46

General Precautions

Dietary Guidelines

Adherence to dietary recommendations minimizes adverse GI effects related to fat intake, as well as contributes to weight loss.1 27 46

Multivitamin Supplementation

Fat-soluble vitamin deficiency is unlikely but possible (see Specific Drugs under Interactions).1 7 8 17 25 26 27 Manufacturers consider routine (once-daily) supplementation with a multivitamin containing fat-soluble vitamins (A, D, E, K) and beta carotene a prudent precaution (see Oral Administration under Dosage and Administration).1 27 37 46

Hepatic Effects

Severe hepatotoxicity (e.g., hepatocellular necrosis, acute hepatic failure), sometimes resulting in liver transplantation or death, reported rarely during postmarketing experience.1 52 53 55 56 57 58 61 62 63 65 66 Elevations in serum aminotransferase (transaminase) and alkaline phosphatase concentrations and hepatitis also reported rarely.1 55

In August 2009, FDA reported that it was conducting an ongoing safety review of orlistat prompted by reports of adverse hepatic-related effects (e.g., serious hepatic injury requiring hospitalization, liver failure) in patients receiving the drug.52 53 55 56 57 58 61 The most commonly reported adverse effects included jaundice, weakness, and abdominal pain.52 53 55 In May 2010, FDA's completed safety review of the available data identified 13 cases of severe liver injury reported in orlistat-treated patients; 2 resulted in death and 3 resulted in liver transplantation.65 66 FDA states that a causal relationship to orlistat cannot be established at this time.65 66

Weigh the benefits of weight loss with orlistat against the potential risks of therapy when considering whether the drug is appropriate for patients.65 66 Instruct patients to report any signs or symptoms possibly associated with the development of hepatic injury (see Advice to Patients).1 27 52 53 65 66 If such manifestations occur or liver injury is suspected, immediately discontinue orlistat and any other suspect drugs and perform liver function tests (including serum ALT and AST concentrations).1 65 66

Hyperoxaluria

Possible increased concentrations of urinary oxalate.1 Use with caution in patients with a history of hyperoxaluria or calcium oxalate nephrolithiasis.1 (See Advice to Patients.)

Diabetes Mellitus

Weight loss may improve glycemic control; dosage reductions or discontinuance of concomitant antidiabetic therapy (e.g., insulin, sulfonylureas, metformin) may be necessary.1 17 27 (See Specific Drugs under Interactions.)

Cholelithiasis

Substantial weight loss may increase risk of cholelithiasis.1 Cholelithiasis reported in patients receiving orlistat and placebo recipients in the clinical trial that evaluated the effect of orlistat on the time to onset of type 2 diabetes mellitus.1 In this trial, the incidence of cholelithiasis was similar for patients receiving orlistat or placebo at similar amounts of weight loss.1 An increased risk of cholelithiasis was not observed in orlistat clinical trials that were not evaluating the prevention of type 2 diabetes.1 (See Advice to Patients.)

Misuse Potential

Avoid use in inappropriate patient populations (e.g., anorexia nervosa, bulimia).1

Specific Populations

Pregnancy

Category B; use not recommended.1 27 46 47

Lactation

Not known whether orlistat is distributed into milk; use not recommended.1 27 46 47

Pediatric Use

Safety and efficacy not established in children <12 years of age.1 Adverse effects in adolescent patients were similar to those observed in adults.1

Do not use for self-medication (Alli) in children <18 years of age.46

Geriatric Use

Insufficient experience with geriatric patients ≥65 years of age to determine whether response differs from younger adults.1

Common Adverse Effects

Oily spotting,1 7 8 48 49 flatus with discharge,1 7 8 46 48 fecal urgency,1 7 8 48 49 fatty/oily stool,1 7 8 48 49 oily evacuation,1 8 49 increased defecation,1 7 8 46 48 49 fecal incontinence.1 7 8 46 49

In clinical studies, adverse effects reported in individuals receiving orlistat 60 mg 3 times daily were similar to those reported in patients receiving 120 mg 3 times daily, and were primarily GI related.49 50

Interactions for Xenical

Specific Drugs

Drug

Interaction

Comments

Alcohol

Pharmacokinetic and pharmacodynamic interaction unlikely1 35

Amiodarone

Reduced amiodarone absorption by 20-25%61 64

Antidiabetic agents

Potential for improved glycemic control;1 17 29 glyburide pharmacokinetics and hypoglycemic effect unchanged in study1 32

Antidiabetic dosage reduction or discontinuance may be necessary1 17 29

Patients should consult a clinician or pharmacist before initiating orlistat for self-medication; antidiabetic dosage adjustment may be necessary46

Antilipemic agents

Possible additive antilipemic effects;1 pravastatin pharmacokinetics unaffected;1 pharmacokinetics of simvastatin and its active metabolite not substantially affected64

Contraceptives, oral

Interaction unlikely1 33

Cyclosporine and other immunosuppressive agents

Decreased plasma cyclosporine concentrations1 27 40 41 42 43 44

Administer cyclosporine ≥2 hours before or after prescription orlistat; consider more frequent monitoring of cyclosporine concentrations1 41 43

Do not use orlistat for self-medication in organ transplant recipients because of possible interaction with immunosuppressive agents (e.g., cyclosporine)46

Digoxin

Pharmacokinetic interaction unlikely1 30

Fluoxetine

Pharmacokinetics of fluoxetine and its metabolite norfluoxetine not substantially affected64

Nifedipine

Pharmacokinetic interaction unlikely with nifedipine extended-release tablets1 31 32

Phenytoin

Pharmacokinetic interaction unlikely1 34

Thyroid agents

Hypothyroidism reported during concurrent orlistat and levothyroxine administration1 60 61

Monitor patients receiving orlistat and levothyroxine concomitantly for changes in thyroid function; administer drugs at least 4 hours apart1

Before initiating orlistat for self-medication, consult a clinician or pharmacist if receiving thyroid agents; thyroid agent dosage adjustment may be needed46

Warfarin

Potential for reduced vitamin K absorption1 28

Closely monitor coagulation parameters; adjust warfarin dosage if necessary1 46

Before initiating orlistat for self-medication, consult a clinician or pharmacist if receiving warfarin; warfarin dosage adjustment may be needed46

Vitamins, fat-soluble (A, D, E, K) and beta carotene

Concentrations of some fat-soluble vitamins and beta carotene decreased but remained within normal range in most individuals1 7 8 17 25 26 27 36 46

Supplementation needed only occasionally in clinical studies;7 8 17 25 26 36 however, manufacturers recommend routine supplementation with multivitamin containing fat-soluble vitamins and beta carotene1 27 37 46

Xenical Pharmacokinetics

Absorption

Bioavailability

Systemic absorption of orlistat is minimal.1 6 21 22

Distribution

Plasma Protein Binding

>99% in vitro (mainly to lipoproteins and albumin).1

Elimination

Metabolism

Metabolized principally in GI wall to clinically unimportant metabolites.1

Elimination Route

Excreted principally in the feces (approximately 97%), mainly as unchanged drug (about 80%).1 6 21 22

Stability

Storage

Oral

Capsules

Prescription orlistat (Xenical): Tight containers at 25°C (may be exposed to 15–30°C).1

Orlistat for self-medication(Alli): 20-25°C; protect from excessive light, humidity, and temperatures >30°C.46

Actions

  • Decreases intestinal lumen absorption of dietary fat (triacylglycerol) by reversibly inhibiting gastric and pancreatic lipase-mediated triglyceride hydrolysis,1 2 4 6 12 18 19 20 21 22 51 thereby decreasing intestinal concentrations of absorbable free fatty acids and monoglycerides.1 4 6 12

  • About one-fourth to one-third of dietary fat will not be absorbed at recommended dosages.1 6 12 18 19 20 47

  • Decreases concentrations of LDL1 3 4 5 6 7 8 20 36 51 and total1 4 5 6 7 8 20 36 cholesterol; variable effects on serum triglycerides1 3 4 5 6 7 20 and HDL cholesterol.3 4 6 7

Advice to Patients

  • Provide copy of manufacturer’s patient information for orlistat (Xenical).1 27 Advise patient to read patient information before beginning treatment and each time prescription is refilled.1 27

  • When using Alli for self-medication, importance of reading the product labeling.46 Information for individuals considering therapy with orlistat or starting orlistat is available at .46

  • In patients taking Xenical, importance of adherence to clinician’s dietary and, if applicable, exercise recommendations.1 15 17 27 Importance of patients using a nutritionally balanced, mildly reduced-calorie diet that contains no more than 30% of total daily calories from fat.27 Evenly distribute daily intake of fat, carbohydrates, and protein over 3 main meals.1 27 Omit orlistat dose if meal contains no fat or is skipped.1 27 47

  • Because orlistat works by blocking the absorption of dietary fat, importance of advising patients that they will likely experience some changes in bowel habits.27 These changes usually occur during the first weeks of treatment, particularly after meals containing higher amounts of fat than recommended, but may continue throughout therapy.27 The changes may include oily spotting, gas with discharge, increased number of bowel movements, and inability to control bowel movements.27 Due to the presence of undigested fat, the oil seen in the bowel movement may be clear or orange or brown in color.27

  • Importance of informing clinicians of any consistent problems absorbing food (chronic malabsorption), gallbladder problems, anorexia, or bulimia.27

  • When used as self-medication, importance of patients advising clinicians if they have problems absorbing food (chronic malabsorption), gallbladder problems, kidney stones, pancreatitis, or severe or continuous abdominal pain.46 47

  • Possible increased risk for developing kidney stones in some patients.1 27 Importance of advising patients to promptly contact their clinician if they experience any symptoms of back pain or blood in the urine.27

  • Possible increased risk for the formation of gall stones in some patients.1 27 Weight loss with orlistat can increase the risk of gall stones.1 27 Importance of advising patients to promptly report any symptoms of pain in the upper right portion of the abdomen; the pain may be accompanied by nausea and vomiting.27

  • Importance of informing patients that there have been rare reports of severe liver injury in orlistat-treated patients.1 27 52 53 65 66 Importance of advising patients to contact their clinician if they experience any symptoms possibly associated with liver injury, such as weakness or fatigue, fever, jaundice (yellowing of the eyes or skin), or dark urine.1 52 53 65 66 Other symptoms may include abdominal or right upper quadrant pain, nausea, vomiting, light-colored stools, itching, or loss of appetite.1 27 52 53 65 66 (See Hepatic Effects under Cautions.)

  • Importance of taking a multivitamin supplement containing vitamins A, D, E, and K and beta carotene once daily at least 2 hours before or after taking orlistat, such as at bedtime.1 27 46 47

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary supplements (including herbal preparations), particularly other antiobesity agents, antidiabetic agents, cyclosporine, or thyroid medication.1 27 46

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 27 46

  • Importance of informing patients of other precautionary information.1 27 46 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Orlistat

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

60 mg

Alli

GlaxoSmithKline

120 mg

Xenical

Genentech

AHFS DI Essentials. © Copyright, 2004-2016, Selected Revisions April 13, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

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