Usual Adult Dose for Hyperlipidemia

3.75 g orally/day; may take as follows:

Oral Tablets:

• Once-daily dosing regimen: 3.75 g (six 625 mg tablets) orally once a day
• Twice-daily dosing regimen: 1.875 g (three 625 mg tablets) orally twice a day

Oral Suspension: 3.75 g packet orally once a day

Chewable Bar: 3.75 g bar orally once a day

Comments:

• This drug may be dosed at the same time as a statin or dosed apart; lipid levels should be monitored within 4 to 6 weeks of initiating this drug.
• This drug has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.

Uses:

• As an adjunct to diet and exercise to reduce elevated low density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia.

Usual Adult Dose for Diabetes Type 2

3.75 g orally/day; may take as follows:

Oral Tablets:

• Once-daily dosing regimen: 3.75 g (six 625 mg tablets) orally once a day
• Twice-daily dosing regimen: 1.875 g (three 625 mg tablets) orally twice a day

Oral Suspension: 3.75 g packet orally once a day

Chewable Bar: 3.75 g bar orally once a day

Comments:

• This drug may be dosed at the same time as a statin or dosed apart; lipid levels should be monitored within 4 to 6 weeks of initiating this drug.
• This drug has not been studied in combination with a dipeptidyl peptidase 4 inhibitor.
• This drug should not be used for the treatment of type 1 diabetes or the treatment of diabetic ketoacidosis.

Uses: As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

Usual Pediatric Dose for Heterozygous Familial Hypercholesterolemia

For boys and postmenarchal girls 10 years or older:

3.75 g orally/day; may take as follows:

Oral Suspension: 3.75 g packet orally once a day

Chewable Bar: 3.75 g bar orally once a day

Comments:

• Due to tablet size, the oral suspension is recommended in the pediatric population.
• This drug may be dosed at the same time as a statin or dosed apart; lipid levels should be monitored within 4 to 6 weeks of initiating this drug.
• The safety and efficacy of this drug was evaluated in pediatric patients with heterozygous familial hypercholesterolemia (HeFH) taking a stable statin dose (with LDL-C greater than 130 mg/dL) or naive to lipid-lowering therapy (with LDL-C greater than 160 mg/dL).

Use: As an adjunct to diet and exercise to reduce elevated low density lipoprotein cholesterol (LDL-C) in boys and postmenarchal girls 10 years or older with primary hyperlipidemia.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended.

Precautions

CONTRAINDICATIONS:

• History of bowel obstruction
• Serum triglyceride (TG) concentrations greater than 500 mg/dL
• History of hypertriglyceridemia-induced pancreatitis

Safety and efficacy have not been established in patients younger than 10 years or in premenarchal girls.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer concomitant medications at least 4 hours prior to taking this drug

Oral Tablets:

• Take orally with meals and liquid; for patients who have difficulty swallowing tablets, consider oral suspension or chewable bars

Oral Suspension:

• Take with meals; do not take oral suspension in its dry form
• To prepare: Empty contents of packet into glass; add 8 ounces of water, fruit juice, or diet soft drink; stir well and drink.

Chewable Bars:

• Take with a meal; each bar contains approximately 80 calories

Storage requirements:

• Protect from moisture

General:

• Drug therapy should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and nonpharmacologic interventions alone have proven inadequate.
• Maximum therapeutic response to the lipid-lowering effects were achieved within 2 weeks and maintained during long term therapy; therapeutic response in diabetes (as reflected by reduction in HbA1c) was observed 4 to 6 weeks after initiating treatment and reached maximal or near-maximal effect 12 to 18 weeks after treatment initiation.

Monitoring:

• Monitor lipids, including triglycerides (TG) and non-HDL-C, at baseline and periodically during therapy; patients with TG levels greater than 300 mg/dL may require additional TG monitoring
• Monitor glycemic control in patients with type 2 diabetes mellitus

Patient advice:

• Patients should be instructed to discontinue therapy and seek immediate medical attention if symptoms of acute pancreatitis occur (e.g., severe abdominal pain with or without nausea/vomiting).
• Patients should understand that this drug may cause constipation; a diet that promotes bowel regularity is recommended; if severe abdominal pain or severe constipation occur, they should contact their healthcare provider promptly.
• Patients should be instructed on proper administration and precautions necessary to avoid drug interactions.