Homozygous Familial Hypercholesterolemia (HoFH) Treatments
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Generic Name
Ezetimibe
Brand Names
Nexlizet, Zetia
FDA approval date: June 12, 2017
Classification: Dietary Cholesterol Absorption Inhibitor
Form: Tablet
What is Nexlizet (Ezetimibe)?
NEXLIZET, a combination of bempedoic acid and ezetimibe, is indicated: As an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol lowering therapies, to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia . The bempedoic acid component of NEXLIZET is indicated: To reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy with: established cardiovascular disease , or a high risk for a CVD event but without established CVD. NEXLIZET, a combination of bempedoic acid, an adenosine triphosphate citrate lyase inhibitor, and ezetimibe, a dietary cholesterol absorption inhibitor, is indicated: As an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol lowering therapies, to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia . The bempedoic acid component of NEXLIZET is indicated: To reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy with: established cardiovascular disease , or a high risk for a CVD event but without established CVD.
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Related Clinical Trials
Utilizing Lipid-lowering Therapy With Moderate-intensity Statin Plus Ezetimibe in Chronic Kidney Disease Patients With Concomitant Atherosclerotic Cardiovascular Disease: ULTRA-CKD Trial
Summary: The ULTRA-CKD trial is a prospective, randomized, open-label, multicenter trial designed to compare the efficacy and safety of moderate-intensity statin plus ezetimibe combination therapy versus high-intensity statin monotherapy in patients with chronic kidney disease (CKD) and concomitant atherosclerotic cardiovascular disease (ASCVD). Patients with CKD are at very high risk for ASCVD. In this po...
A Phase I, Randomized, Open-label, 4-period, 4-treatment, Single-dose, Cross-over Study to Assess the Relative Bioavailability of Laroprovstat/Ezetimibe Fixed Combination Drug Products to the Single Therapy Products in Healthy Adults
Summary: The purpose of this study is to assess how well laroprovstat and ezetimibe combined in a single tablet to be taken by mouth works and what the body does to the drug (pharmacokinetics) compared with laroprovstat and ezetimibe individual tablets to be taken by mouth (relative bioavailability) as well as to see if there is any effect of eating compared to fasting (food effect) in healthy adults.
Effectiveness and Safety of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia: an Observational Study
Summary: Data on the real-world use and effectiveness and safety of bempedoic acid combined with both a statin and ezetimibe in clinical practice is limited. There is an increased focus on using combination therapy to lower LDL-C.
Related Latest Advances
Brand Information
Nexlizet (Bempedoic Acid and Ezetimibe)
1INDICATIONS AND USAGE
NEXLIZET, a combination of bempedoic acid and ezetimibe, is indicated:
- as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).
Bempedoic acid, a component of NEXLIZET, is indicated:
- to reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, or coronary revascularization) in adults at increased risk for these events who are unable to take recommended statin therapy (including those not taking a statin).
2DOSAGE FORMS AND STRENGTHS
NEXLIZET is available as:
- Tablets: 180 mg/10 mg, blue, oval shaped, debossed with "818" on one side and "ESP" on the other side.
3CONTRAINDICATIONS
NEXLIZET is contraindicated in patients with a prior hypersensitivity to ezetimibe or bempedoic acid or any of the excipients in NEXLIZET
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hyperuricemia
- Tendon Rupture
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
4.2Postmarketing Experience
The following adverse reactions have been identified during post approval use of ezetimibe and/or bempedoic acid. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood Disorders: thrombocytopenia
Gastrointestinal Disorders: abdominal pain; pancreatitis; nausea
Hepatobiliary Disorders: elevations in liver transaminases, including elevations more than 5× ULN; hepatitis; cholelithiasis; cholecystitis
Immune System Disorders: Hypersensitivity reactions including: anaphylaxis, angioedema, wheezing, rash, and urticaria
Musculoskeletal Disorders: elevated creatine phosphokinase; myopathy/rhabdomyolysis
Nervous System Disorders: dizziness; paresthesia; depression; headache
Skin and Subcutaneous Tissue Disorders: erythema multiforme
5DRUG INTERACTIONS
No specific pharmacokinetic drug interaction studies with NEXLIZET have been conducted. Table 4 lists drug interactions with NEXLIZET that have been identified in studies with bempedoic acid or ezetimibe.
6OVERDOSAGE
There is no clinical experience with NEXLIZET overdosage. In the event of an overdosage, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.
7DESCRIPTION
NEXLIZET tablets, for oral use, contain bempedoic acid, an adenosine triphosphate-citrate lyase (ACL) inhibitor, and ezetimibe, a dietary cholesterol absorption inhibitor.
The chemical name for bempedoic acid is 8-hydroxy-2,2,14,14-tetramethyl-pentadecanedioic acid. The molecular formula is C
Structural formula:
The chemical name for ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)- hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C
Structural formula:
Each film-coated tablet of NEXLIZET contains 180 mg of bempedoic acid and 10 mg of ezetimibe, and the following inactive ingredients: colloidal silicon dioxide, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K30, sodium lauryl sulfate, sodium starch glycolate. The film coating comprises of FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, glyceryl monocaprylocaprate, partially hydrolyzed polyvinyl alcohol, sodium lauryl sulfate, talc, and titanium dioxide.
8PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labeling (Patient Information).
9PRINCIPAL DISPLAY PANEL - 180 mg/10 mg Tablet Bottle Label
NDC 72426-818-03
NEXLIZET
Contains
180 mg/10 mg
