Liptruzet (ezetimibe and atorvastatin)

Liptruzet is indicated for the reduction of

• elevated total cholesterol (total-C),
• low-density lipoprotein cholesterol (LDL-C),
• apolipoprotein B (Apo B),
• triglycerides (TG), and
• non-high-density lipoprotein cholesterol (non-HDL-C), and to
  • increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia.

Liptruzet contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and atorvastatin, a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor.

The following serious adverse reactions are discussed in greater detail in other sections of the label:

• Rhabdomyolysis and myopathy
• Liver enzyme abnormalities

The most common adverse reactions in the group treated with Liptruzet that led to treatment discontinuation and occurred at a rate greater than placebo were:

• Myalgia (0.8%)
• Abdominal pain (0.8%)
• Increased hepatic enzymes (0.8%)

The most commonly reported adverse reactions (incidence ≥2% and greater than placebo) were:

• increased ALT (5%),
• increased AST (4%), and
• musculoskeletal pain (4%).

• The dosage range of Liptruzet is 10/10 mg/day to 10/80 mg/day.
• The recommended starting dose of Liptruzet is 10/10 mg/day or 10/20 mg/day.
• Liptruzet can be administered as a single dose at any time of the day, with or without food.
• The recommended starting dose for patients who require a larger reduction in LDL-C (greater than 55%) is 10/40 mg/day.
• After initiation and/or upon titration of Liptruzet, lipid levels should be analyzed within 2 or more weeks and dosage adjusted accordingly.
• Patients should swallow Liptruzet tablets whole. Tablets should not be crushed, dissolved, or chewed

The risk of myopathy during treatment with statins is increased with concurrent administration of

• fibric acid derivatives,
• lipid-modifying doses of niacin,
• cyclosporine, or
• strong CYP3A4 inhibitors (e.g., clarithromycin, HIV protease inhibitors, and itraconazole).

• Liptruzet is contraindicated in women who are or may become pregnant.
• Serum cholesterol and triglycerides increase during normal pregnancy. Lipid-lowering drugs offer no benefit during pregnancy, because cholesterol and cholesterol derivatives are needed for normal fetal development.
• There are no adequate and well-controlled studies of Liptruzet use during pregnancy.
• There have been rare reports of congenital anomalies following intrauterine exposure to statins.
• Women who are breastfeeding should be advised to not use Liptruzet.
• Patients who have a lipid disorder and are breastfeeding should be advised to discuss the options with their healthcare professionals.