NEXLIZET Prescribing Information
NEXLETOL Prescribing Information
|
|
|
|
|
For your patients who require additional support in
managing their low-density lipoprotein cholesterol
(LDL-C) levels, nonstatin therapies like NEXLIZET®
(bempedoic acid/ezetimibe) and NEXLETOL®
(bempedoic acid) may be valuable treatment options.
Clinical trials show that these FDA-approved therapies
can lower LDL-C and reduce the risk of MI and coronary
revascularization in both primary and secondary
prevention patients.
I invite you to review the LDL-C reduction and CV
outcomes data below to understand how these therapies
may support your approach to treating appropriate
patients. Please see below for full Indication and
Important Safety Information.
Nicole A. Ciffone MS, ANP-C, AACC, FNLA
|
|
|
|
|
Significant LDL-C lowering
|
|
NEXLIZET* and NEXLETOL are the only nonstatins FDA approved to lower
LDL-C and reduce the risk of MI and coronary revascularization in
primary prevention and secondary prevention patients
|
|
*
|
The bempedoic acid component.
|
|
|
|
IndicatioN
|
|
NEXLIZET and NEXLETOL are indicated:
|
|
•
|
|
The bempedoic acid component of NEXLIZET and
NEXLETOL is indicated to reduce the risk of
myocardial infarction and coronary
revascularization in adults who are unable to
take recommended statin therapy (including those
not taking a statin) with:
|
|
|
established cardiovascular disease
(CVD), or
|
|
|
at high risk for a CVD event but
without established CVD.
|
|
|
|
•
|
|
As an adjunct to diet:
|
|
|
NEXLIZET, alone or in combination
with other LDL-C lowering therapies,
to reduce LDL-C in adults with
primary hyperlipidemia, including
HeFH.
|
|
|
NEXLETOL, in combination with other
LDL-C lowering therapies, or alone
when concomitant LDL-C lowering
therapy is not possible, to reduce
LDL-C in adults with primary
hyperlipidemia, including HeFH.
|
|
|
|
|
IMPORTANT SAFETY INFORMATION
|
|
•
|
NEXLIZET and NEXLETOL are contraindicated in patients with a
prior hypersensitivity to bempedoic acid or ezetimibe or any
of the excipients. Serious hypersensitivity reactions
including anaphylaxis, angioedema, rash, and urticaria have
been reported.
|
|
|
See additional Important Safety Information below.
|
|
Explore LDL-C reduction
|
|
|
053 trial with NEXLIZET: Mean change in LDL-C from baseline
to Week 12
|
|
|
|
Placebo corrected
|
|
|
LDL-C changes from baseline (LS mean; P<0.001):
|
|
•
|
NEXLIZET: -36% (n=86)
|
|
•
|
Placebo: +2% (n=41)
|
|
|
Consistent efficacy has been observed across a range of statin
intensities1,3:
|
|
•
|
Of the 301 patients in the 053 trial, 65% were on a statin;
35% were on a high-intensity dose
|
|
|
Maximum LDL-C lowering effect was observed at Week 4.
|
|
Study Design
|
|
053 trial: A 12-week, randomized, double-blind, Phase 3 trial in 301
patients with HeFH, established CVD, or multiple risk factors for CVD
taking a maximally tolerated statin and randomized 2:2:2:1 to receive
NEXLIZET (n=86), NEXLETOL (n=88), ezetimibe (n=86), or placebo (n=41).
The primary endpoint was percent change from baseline to Week 12 in
LDL-C. Results shown are based on a mean 38% placebo-corrected LDL-C
reduction (-36% NEXLIZET vs +2% placebo).
|
Discover more clinical data from
NEXLIZET and NEXLETOL
|
|
|
IMPORTANT SAFETY INFORMATION (cont.)
|
|
•
|
Hyperuricemia: Bempedoic acid, a component of
NEXLIZET and NEXLETOL, may increase blood uric acid levels,
which may lead to gout. Hyperuricemia may occur early in
treatment and persist throughout treatment, returning to
baseline following discontinuation of treatment. Assess uric
acid levels periodically as clinically indicated. Monitor
for signs and symptoms of hyperuricemia, and initiate
treatment with urate-lowering drugs as appropriate.
|
|
•
|
Tendon Rupture: Bempedoic acid, a component of
NEXLIZET and NEXLETOL, is associated with an increased risk
of tendon rupture or injury. Tendon rupture may occur more
frequently in patients over 60 years of age, in those
taking corticosteroid or fluoroquinolone drugs, in patients
with renal failure, and in patients with previous tendon
disorders. Discontinue NEXLIZET or NEXLETOL at the first
sign of tendon rupture. Consider alternative therapy in
patients who have a history of tendon disorders or tendon
rupture.
|
|
•
|
The most common adverse reactions in the primary
hyperlipidemia trials of bempedoic acid, a component of
NEXLIZET and NEXLETOL, in ≥2% of patients and greater than
placebo were upper respiratory tract infection, muscle
spasms, hyperuricemia, back pain, abdominal pain or
discomfort, bronchitis, pain in extremity, anemia, and
elevated liver enzymes.
|
|
•
|
Adverse reactions reported in ≥2% of patients treated with
ezetimibe (a component of NEXLIZET) and at an incidence
greater than placebo in clinical trials were upper
respiratory tract infection, diarrhea, arthralgia,
sinusitis, pain in extremity, fatigue, and influenza.
|
|
•
|
In the primary hyperlipidemia trials of NEXLIZET, the most
commonly reported adverse reactions (incidence ≥3% and
greater than placebo) observed with NEXLIZET, but not
observed in clinical trials of bempedoic acid or ezetimibe,
were urinary tract infection, nasopharyngitis, and
constipation.
|
|
•
|
The most common adverse reactions in the cardiovascular
outcomes trial for bempedoic acid, a component of NEXLIZET
and NEXLETOL, at an incidence of ≥2% and 0.5% greater than
placebo were hyperuricemia, renal impairment, anemia,
elevated liver enzymes, muscle spasms, gout, and
cholelithiasis.
|
|
•
|
Concomitant use of NEXLIZET or NEXLETOL with greater than 20
mg of simvastatin or 40 mg of pravastatin should be avoided
due to the potential for increased risk of simvastatin- or
pravastatin-related myopathy.
|
|
•
|
Discontinue NEXLIZET or NEXLETOL when pregnancy is
recognized unless the benefits of therapy outweigh the
potential risks to the fetus. Because of the potential for
serious adverse reactions in a breast-fed infant,
breastfeeding is not recommended during treatment with
NEXLIZET or NEXLETOL.
|
|
•
|
Report pregnancies to Esperion Therapeutics, Inc. Adverse
Event reporting line at 1-833-377-7633.
|
|
|
Please see full Prescribing Information for NEXLIZET and NEXLETOL.
|
|
CV=cardiovascular; HeFH=heterozygous familial hypercholesterolemia;
LDL-C=low-density lipoprotein cholesterol; LS=least squares;
MI=myocardial infarction.
|
|
References: 1. NEXLIZET. Prescribing information. Esperion
Therapeutics, Inc. 2. NEXLETOL. Prescribing information. Esperion
Therapeutics, Inc. 3. Ballantyne CM, Laufs U, Ray KK, et al.
Bempedoic acid plus ezetimibe fixed-dose combination in patients with
hypercholesterolemia and high CVD risk treated with maximally tolerated
statin therapy. EJPC. 2020;27(6):593-603.
|
|
|
|
|
This information is intended only for healthcare professionals in
the United States.
All trademarks and trade names are the property of their respective
owners.
© 2025 Esperion Therapeutics, Inc. All rights reserved.
US‑NXNZ-2500043
|
|
|
|
