What is Liptruzet and how does it work?
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.
What are the side effects of Liptruzet?
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%).
What is the dosage for Liptruzet?
- 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
What drugs interact with Liptruzet?
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).
Is Liptruzet safe to take when pregnant or breastfeeding?
- 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.