Orlistat

Substantial weight loss may increase the risk of cholelithiasis.

Cases of severe liver injury (some fatal) with hepatocellular necrosis or acute hepatic failure have been reported; liver transplantation has been required in some patients. Patients should be instructed to report any symptoms of hepatic impairment (eg, anorexia, pruritus, jaundice, dark urine, light colored stools, right upper quadrant pain); discontinue therapy immediately and obtain liver function tests if symptoms occur.

Increased levels of urinary oxalate following treatment may occur in some patients; cases of oxalate nephrolithiasis and oxalate nephropathy with renal failure have been reported. Monitor renal function in patients at risk for renal impairment; use with caution in patients with a history of hyperoxaluria or calcium oxalate nephrolithiasis. Disease-related concerns:

Monitor patients with diabetes closely; weight loss may affect glycemic control. Dosage adjustments of antidiabetic medications may be necessary. Concurrent drug therapy issues:

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special populations:

When used in adolescents, weight related to growth is accounted for in BMI, therefore, reduction in BMI is a better indicator of weight loss. Other warnings/precautions:

Prior to use, other causes for obesity (eg, hypothyroidism) should be ruled out. According to Endocrine Society practice guidelines, weight loss medication should be discontinued and alternative treatment considered if weight loss is • Dietary guidelines: Patients should be advised to adhere to dietary guidelines; if taken with a diet high in fat (>30% total daily calories from fat), gastrointestinal adverse events may increase. Distribute daily fat intake over 3 main meals. If taken with any 1 meal very high in fat, the possibility of gastrointestinal effects increases. Counsel patients to take a multivitamin supplement that contains fat-soluble vitamins ≥2 hours before or after orlistat administration to ensure adequate nutrition; orlistat has been shown to reduce the absorption of some fat-soluble vitamins and beta-carotene.

The potential exists for misuse in inappropriate patient populations (eg, patients with anorexia nervosa or bulimia) similar to any weight loss agent.

Prior to use, patients should contact their healthcare provider if they have ever had kidney stones, gall bladder disease, or pancreatitis. Patients taking medications for diabetes or thyroid disease, seizures, anticoagulants, or other weight-loss products should consult their healthcare provider or pharmacist before use. Patients who have had an organ transplant should not use orlistat. If severe and/or continuous abdominal pain, itching, yellowing of the eyes or skin, dark urine, loss of appetite occurs, or seizures worsen, use should be discontinued and healthcare provider consulted.