Venustat® Plus

120 mg 3 times daily with each main meal containing fat (during or up to 1 hour after the meal); omit dose if meal is occasionally missed or contains no fat.

OTC labeling: 60 mg 3 times daily with each main meal containing fat (maximum dose: 180 mg/day).

Take multivitamin capsule 2 hours after venustat^® capsule.

Contraindications:

Hypersensitivity to orlistat or to any component of the formulation; pregnancy; chronic malabsorption syndrome; cholestasis.

Interactions:

CycloSPORINE (Systemic): Orlistat may decrease the serum concentration of CycloSPORINE (Systemic). Management: Administer oral cyclosporine 3 hours after orlistat. Monitor for decreased serum concentrations of oral cyclosporine, even with the recommended dose separation. Risk D: Consider therapy modification

Levothyroxine: Orlistat may decrease the serum concentration of Levothyroxine. Management: Separate administration of oral levothyroxine and orlistat by a least 4 hours. Monitor patients closely for signs and symptoms of hypothyroidism. Risk D: Consider therapy modification

Multivitamins/Minerals (with ADEK, Folate, Iron): Orlistat may decrease the serum concentration of Multivitamins/Minerals (with ADEK, Folate, Iron). Specifically, orlistat may impair the absorption of fatsoluble 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 orlistat. Risk D: Consider therapy modification

Pregnancy and Lactation:

An increased risk of adverse maternal and fetal outcomes is associated with obesity. However, moderate weight gain based on prepregnancy BMI is required for positive fetal outcomes. Therefore, medications for weight loss therapy are not recommended during pregnancy.

Orlistat has minimal systemic absorption. The manufacturer recommends caution be used if administered to a breastfeeding female.

Warning and Precaution:

• Cholelithiasis: Substantial weight loss may increase the risk of cholelithiasis.
• Hepatotoxicity: 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 urinary oxalate: 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

Adverse Reactions:

Central nervous system: Headache (≤31%), fatigue (3% to 7%), anxiety (3% to 5%), sleep disorder (≤4%)

Dermatologic: Xeroderma (≤2%)

Endocrine & metabolic: Menstrual disease (≤10%), hypoglycemia (in patients with diabetes)

Gastrointestinal: Oily rectal leakage (4% to 27%), abdominal distress (≤26%), abdominal pain (≤26%), flatulence with discharge (2% to 24%), bowel urgency (3% to 22%), steatorrhea (6% to 20%), oily evacuation (2% to 12%), frequent bowel movements (3% to 11%), nausea (4% to 8%), fecal incontinence (2% to 8%), infectious diarrhea (≤5%), rectal pain (3% to 5%), gingival disease (4%), cholelithiasis (3%), abdominal distension (in patients with diabetes)

Genitourinary: Urinary tract infection (6% to 8%), vaginitis (3%) Infection: Influenza (≤40%)

Neuromuscular & skeletal: Back pain (≤14%), leg pain (≤11%), myalgia (≤4%)

Otic: Otitis (4%)

Respiratory: Upper respiratory tract infection (38%), lower respiratory tract infection (≤8%)

Storage:

Store below 30ºC and protect from light and moisture.