What Is Nexletol?
Nexletol (bempedoic acid) is an adenosine triphosphate-citrate lyase (ACL) inhibitor used as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.
What Are Side Effects of Nexletol?
Side effects of Nexletol include:
- upper respiratory tract infection,
- muscle spasms,
- high levels of uric acid in the blood,
- back pain,
- abdominal pain or discomfort,
- bronchitis,
- pain in extremities,
- anemia, and
- elevated liver enzymes
Dosage for Nexletol
The dose of Nexletol is 180 mg administered orally once daily with or without food.
Nexletol In Children
The safety and effectiveness of Nexletol have not been established in pediatric patients.
What Drugs, Substances, or Supplements Interact with Nexletol?
Nexletol may interact with other medicines such as:
- simvastatin and
- pravastatin
Tell your doctor all medications and supplements you use.
Nexletol During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Nexletol; it may harm a fetus. Discontinue Nexletol when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. It is unknown if Nexletol passes into breast milk. Because of the potential for serious adverse reactions in a breastfed infant, based on the mechanism of action, breastfeeding is not recommended while using Nexletol.
Additional Information
Our Nexletol (bempedoic acid) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
QUESTION
What is cholesterol? See AnswerGet emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop taking bempedoic acid and seek medical attention right away if you have signs of tendon rupture:
- sudden pain, swelling, bruising, or tenderness;
- stiffness, movement problems; or
- or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions).
Call your doctor at once if you have:
- severe foot or toe pain;
- joint pain or swelling;
- warmth or redness over your joints; or
- low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.
Common side effects may include:
- pain in your back, shoulder, legs, or arms;
- muscle spasm;
- stomach pain;
- anemia;
- abnormal liver function tests;
- wheezing, cough, chest congestion; or
- cold symptoms such as stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
SLIDESHOW
How to Lower Your Cholesterol & Save Your Heart See SlideshowSIDE EFFECTS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hyperuricemia [see WARNINGS AND PRECAUTIONS]
- Tendon Rupture [see WARNINGS AND PRECAUTIONS]
Clinical 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.
The data described below reflect exposure to NEXLETOL in two placebo-controlled trials that included 2009 patients treated with NEXLETOL for 52 weeks (median treatment duration of 52 weeks) [see Clinical Studies]. The mean age for NEXLETOL-treated patients was 65.4 years, 29% were women, 3% were Hispanic, 95% White, 3% Black, 1% Asian, and 1% other races. All patients received NEXLETOL 180 mg orally once daily plus maximally tolerated statin therapy alone or in combination with other lipid-lowering therapies. At baseline, 97% of patients had clinical atherosclerotic cardiovascular disease (ASCVD) and about 4% had a diagnosis of heterozygous familial hypercholesterolemia (HeFH). Patients on simvastatin 40 mg/day or higher were excluded from the trials.
Adverse reactions led to discontinuation of treatment in 11% of NEXLETOL-treated patients and 8% of placebo-treated patients. The most common reasons for NEXLETOL treatment discontinuation were muscle spasms (0.5% versus 0.3% placebo), diarrhea (0.4% versus 0.1% placebo), and pain in extremity (0.3% versus 0.0% placebo). Adverse reactions reported in at least 2% of NEXLETOL-treated patients and more frequently than in placebo-treated patients are shown in Table 1.
Table 1: Adverse Reactions (≥ 2% and Greater than placebo) in NEXLETOL-Treated Patients with ASCVD and HeFH (Studies 1 and 2)
| Adverse Reaction | NEXLETOL + Statin and ± Other Lipid Lowering Therapies (N = 2009) % | Placebo (N = 999) % |
| Upper respiratory tract infection | 4.5 | 4.0 |
| Muscle spasms | 3.6 | 2.3 |
| Hyperuricemiaa | 3.5 | 1.1 |
| Back pain | 3.3 | 2.2 |
| Abdominal pain or discomfortb | 3.1 | 2.2 |
| Bronchitis | 3.0 | 2.5 |
| Pain in extremity | 3.0 | 1.7 |
| Anemia | 2.8 | 1.9 |
| Elevated liver enzymesc | 2.1 | 0.8 |
| a Hyperuricemia includes hyperuricemia and blood uric acid increased. b Abdominal pain or discomfort includes abdominal pain, abdominal pain upper, abdominal pain lower, and abdominal discomfort. c Elevated liver enzymes includes AST increased, ALT increased, hepatic enzyme increased, and liver function test increased. | ||
Tendon Rupture
NEXLETOL was associated with an increased risk of tendon rupture, occurring in 0.5% of NEXLETOL-treated patients versus 0% of placebo-treated patients.
Gout
NEXLETOL was associated with an increased risk of gout, occurring in 1.5% of NEXLETOL-treated patients versus 0.4% of placebo-treated patients.
Benign Prostatic Hyperplasia
NEXLETOL was associated with an increased risk of benign prostatic hyperplasia (BPH) or prostatomegaly in men with no reported history of BPH, occurring in 1.3% of NEXLETOL-treated patients versus 0.1% of placebo-treated patients. The clinical significance is unknown.
Atrial Fibrillation
NEXLETOL was associated with an imbalance in atrial fibrillation, occurring in 1.7% of NEXLETOL-treated patients versus 1.1% of placebo-treated patients.
Laboratory Tests
NEXLETOL was associated with persistent changes in multiple laboratory tests within the first 4 weeks of treatment. Laboratory test values returned to baseline following discontinuation of treatment.
Increase In Creatinine And Blood Urea Nitrogen
Overall, there was a mean increase in serum creatinine of 0.05 mg/dL compared to baseline with NEXLETOL at Week 12. Approximately 3.8% of patients treated with NEXLETOL had blood urea nitrogen values that doubled (versus 1.5% placebo), and about 2.2% of patients had creatinine values that increased by 0.5 mg/dL (versus 1.1% placebo).
Decrease In Hemoglobin And Leukocytes
Approximately 5.1% of patients (versus 2.3% placebo) had decreases in hemoglobin levels of 2 or more g/dL and below the lower limit of normal on one or more occasion. Anemia was reported in 2.8% of patients treated with NEXLETOL and 1.9% of patients treated with placebo. Hemoglobin decrease was generally asymptomatic and did not require medical intervention. Decreased leukocyte count was also observed. Approximately 9.0% of NEXLETOL-treated patients with normal baseline leukocyte count had a decrease to less than the lower limit of normal on one or more occasion (versus 6.7% placebo). Leukocyte decrease was generally asymptomatic and did not require medical intervention. In clinical trials, there was a small imbalance in skin or soft tissue infections, including cellulitis (0.8% versus 0.4%), but there was no imbalance in other infections.
Increase In Platelet Count
Approximately 10.1% of patients (versus 4.7% placebo) had increases in platelet counts of 100x 109/L or more on one or more occasion. Platelet count increase was asymptomatic, did not result in increased risk for thromboembolic events, and did not require medical intervention.
Increase In Liver Enzymes
Increases in hepatic transaminases (AST and/or ALT) were observed with NEXLETOL. In most cases, the elevations were transient and resolved or improved with continued therapy or after discontinuation of therapy. Increases to more than 3x the upper limit of normal (ULN) in AST occurred in 1.4% of patients treated with NEXLETOL versus 0.4% of placebo patients, and increases to more than 5x ULN occurred in 0.4% of NEXLETOL-treated versus 0.2% of placebo-treated patients. Increases in ALT occurred with similar incidence between NEXLETOL-and placebo-treated patients. Elevations in transaminases were generally asymptomatic and not associated with elevations ≥2x ULN in bilirubin or with cholestasis.
Increase In Creatine Kinase
Approximately 1.0% of patients (versus 0.6% placebo) had elevations of CK levels of 5 or more times the normal value on one or more occasions, and 0.4% of patients (versus 0.2% placebo) had elevations of CK levels of 10 or more times.
Read the entire FDA prescribing information for Nexletol (Bempedoic Acid Tablets, for Oral Use)
© Nexletol Patient Information is supplied by Cerner Multum, Inc. and Nexletol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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