Usual Adult Dose for Hyperlipidemia

600 mg orally twice a day, 30 minutes before the morning and evening meals

Uses: As an adjunct to diet in the following situations: to treat hypertriglyceridemia in Types IV and V hyperlipidemia in patients who present at risk for pancreatitis and who do not respond adequately to diet; to reduce the risk for coronary heart disease (CHD) only in Type IIb patients without a history of or symptoms of existing CHD who have not responded adequately to other pharmacologic agents and nonpharmacologic interventions and who have low high density lipoprotein (HDL), elevated low density lipoprotein (LDL), and elevated triglycerides

Usual Adult Dose for Hyperlipoproteinemia Type IIb (Elevated LDL + VLDL)

600 mg orally twice a day, 30 minutes before the morning and evening meals

Uses: As an adjunct to diet in the following situations: to treat hypertriglyceridemia in Types IV and V hyperlipidemia in patients who present at risk for pancreatitis and who do not respond adequately to diet; to reduce the risk for coronary heart disease (CHD) only in Type IIb patients without a history of or symptoms of existing CHD who have not responded adequately to other pharmacologic agents and nonpharmacologic interventions and who have low high density lipoprotein (HDL), elevated low density lipoprotein (LDL), and elevated triglycerides

Usual Adult Dose for Hyperlipoproteinemia Type IV (Elevated VLDL)

600 mg orally twice a day, 30 minutes before the morning and evening meals

Uses: As an adjunct to diet in the following situations: to treat hypertriglyceridemia in Types IV and V hyperlipidemia in patients who present at risk for pancreatitis and who do not respond adequately to diet; to reduce the risk for coronary heart disease (CHD) only in Type IIb patients without a history of or symptoms of existing CHD who have not responded adequately to other pharmacologic agents and nonpharmacologic interventions and who have low high density lipoprotein (HDL), elevated low density lipoprotein (LDL), and elevated triglycerides

Usual Adult Dose for Hyperlipoproteinemia Type V (Elevated Chylomicrons + VLDL)

600 mg orally twice a day, 30 minutes before the morning and evening meals

Uses: As an adjunct to diet in the following situations: to treat hypertriglyceridemia in Types IV and V hyperlipidemia in patients who present at risk for pancreatitis and who do not respond adequately to diet; to reduce the risk for coronary heart disease (CHD) only in Type IIb patients without a history of or symptoms of existing CHD who have not responded adequately to other pharmacologic agents and nonpharmacologic interventions and who have low high density lipoprotein (HDL), elevated low density lipoprotein (LDL), and elevated triglycerides

Usual Adult Dose for Hypertriglyceridemia

600 mg orally twice a day, 30 minutes before the morning and evening meals

Uses: As an adjunct to diet in the following situations: to treat hypertriglyceridemia in Types IV and V hyperlipidemia in patients who present at risk for pancreatitis and who do not respond adequately to diet; to reduce the risk for coronary heart disease (CHD) only in Type IIb patients without a history of or symptoms of existing CHD who have not responded adequately to other pharmacologic agents and nonpharmacologic interventions and who have low high density lipoprotein (HDL), elevated low density lipoprotein (LDL), and elevated triglycerides

Usual Adult Dose for Prevention of Cardiovascular Disease

600 mg orally twice a day, 30 minutes before the morning and evening meals

Uses: As an adjunct to diet in the following situations: to treat hypertriglyceridemia in Types IV and V hyperlipidemia in patients who present at risk for pancreatitis and who do not respond adequately to diet; to reduce the risk for coronary heart disease (CHD) only in Type IIb patients without a history of or symptoms of existing CHD who have not responded adequately to other pharmacologic agents and nonpharmacologic interventions and who have low high density lipoprotein (HDL), elevated low density lipoprotein (LDL), and elevated triglycerides

Renal Dose Adjustments

Severe renal dysfunction: Contraindicated

Liver Dose Adjustments

Hepatic dysfunction (including primary biliary cirrhosis): Contraindicated

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any product ingredients
• Preexisting gallbladder disease
• Hepatic dysfunction (including primary biliary cirrhosis)
• Severe renal dysfunction
• Concomitant use with simvastatin, replaglinide, dasabuvir, or selexipag

Dialysis

Data not available

Other Comments

Administration advice:

• Take orally twice a day, 30 minutes before the morning and evening meals
• Administer 2 hours or more apart from bile acid-binding resins

• Store at controlled room temperature; protect from light and humidity

• Prior to initiating treatment, every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities.
• Treatment is not indicated for patients with Type I hyperlipoproteinemia who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL), nor is it indicated in patients with low HDL as their only lipid abnormality.
• Due to the potential for toxicity, this drug is not indicated for treatment in patients with Type IIa elevations of LDL when this is the only abnormality.

• Hepatic: Periodically measure liver function tests.
• Hematologic: Measure blood counts periodically during first 12 months of therapy.
• Metabolic: Periodically measure serum lipid levels; treatment should be withdrawn if lipid response is inadequate after 3 months of therapy.

• Advise patients to report muscle pain, weakness, or tenderness, immediately.
• Patients should talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding.