Nexlizet
- Generic Name: bempedoic acid and ezetimibe tablets
- Brand Name: Nexlizet
Nexlizet (Bempedoic acid and Ezetimibe Tablets) side effects drug center
Nexlizet Side Effects Center
What Is Nexlizet?
Nexlizet (bempedoic acid and ezetimibe) contains an adenosine triphosphate-citrate lyase (ACL) inhibitor and a cholesterol absorption inhibitor and is 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 Nexlizet?
Side effects of Nexlizet include:
- upper respiratory tract infection,
- muscle spasms,
- high uric acid in the blood (hyperuricemia),
- back pain,
- abdominal pain or discomfort,
- bronchitis,
- pain in extremities,
- anemia,
- elevated liver enzymes,
- diarrhea,
- joint pain,
- sinusitus,
- fatigue,
- influenza,
- increased risk of tendon rupture, and
- increased risk of gout
Dosage for Nexlizet
The dose of Nexlizet is one tablet (180 mg bempedoic acid and 10 mg ezetimibe) administered orally once daily with or without food.
Nexlizet In Children
The safety and effectiveness of Nexlizet have not been established in pediatric patients.
What Drugs, Substances, or Supplements Interact with Nexlizet?
Nexlizet may interact with other medicines such as:
- simvastatin,
- pravastatin,
- cyclosporine,
- fibrates, and
- cholestyramine
Tell your doctor all medications and supplements you use.
Nexlizet During Pregnancy and Breastfeeding
Nexlizet is generally not recommended for use during pregnancy; It may harm a fetus. Discontinue Nexlizet when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. It is unknown if Nexlizet passes into breast milk. Because of the potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended while using Nexlizet.
Additional Information
Our Nexlizet (bempedoic acid and ezetimibe) 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.
Nexlizet Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives, rash, severe itching, skin redness or swelling; wheezing, difficult breathing, feeling light-headed; fast or pounding heartbeats; swelling of your face, lips, tongue, or throat.
Some side effects of bempedoic acid and ezetimibe can occur weeks or months after you have started taking this medicine.
Stop taking this medicine and get medical help right away if you have signs of tendon rupture--sudden pain, swelling, bruising, tenderness, stiffness, movement problems, 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:
- low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
- symptoms of gout--joint pain or swelling, warmth or redness around your joints, severe foot or toe pain.
Common side effects may include:
- stomach pain, diarrhea;
- anemia;
- cough, chest tightness, shortness of breath;
- muscle spasm, back pain, joint pain;
- pain in your shoulder, arms, or legs;
- abnormal liver function tests;
- tiredness; or
- cold or flu symptoms such as fever, chills, body aches, 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.
Read the entire detailed patient monograph for Nexlizet (Bempedoic acid and Ezetimibe Tablets)
Nexlizet Professional Information
SIDE 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.
Bempedoic Acid
The data described below reflect exposure to bempedoic acid in two placebo-controlled trials that included 2009 patients treated with bempedoic acid for 52 weeks (median treatment duration of 52 weeks) [see Clinical Studies]. The mean age for bempedoic acid-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 bempedoic acid 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 bempedoic acid-treated patients and 8% of placebo-treated patients. The most common reasons for bempedoic acid 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 bempedoic acid-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 Bempedoic Acid-Treated Patients with ASCVD and HeFH
| Adverse Reaction | Bempedoic acid + 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
Bempedoic acid was associated with an increased risk of tendon rupture, occurring in 0.5% of bempedoic acid-treated patients versus 0% of placebo-treated patients.
Gout
Bempedoic acid was associated with an increased risk of gout, occurring in 1.5% of bempedoic acid-treated patients versus 0.4% of placebo-treated patients.
Benign Prostatic Hyperplasia
Bempedoic acid 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 bempedoic acid-treated patients versus 0.1% of placebo-treated patients. The clinical significance is unknown.
Atrial Fibrillation
Bempedoic acid was associated with an imbalance in atrial fibrillation, occurring in 1.7% of bempedoic acid-treated patients versus 1.1% of placebo-treated patients.
Laboratory Tests
Bempedoic acid 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 bempedoic acid at Week 12. Approximately 3.8% of patients treated with bempedoic acid 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).
Decreased Hemoglobin and Leukocytes
Approximately 5.1% of patients treated with bempedoic acid (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 bempedoic acid 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 bempedoic acid-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 bempedoic acid-treated patients (versus 4.7% placebo) had increases in platelet counts of 100 × 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 bempedoic acid. In most cases, the elevations were transient and resolved or improved with continued therapy or after discontinuation of therapy. Increases to more than 3× the upper limit of normal (ULN) in AST occurred in 1.4% of patients treated with bempedoic acid versus 0.4% of placebo patients, and increases to more than 5× ULN occurred in 0.4% of bempedoic acid-treated versus 0.2% of placebo-treated patients. Increases in ALT occurred with similar incidence between bempedoic acid-and placebo-treated patients. Elevations in transaminases were generally asymptomatic and not associated with elevations ≥2× ULN in bilirubin or with cholestasis.
Increase in Creatinine 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.
Ezetimibe
In 10 double-blind, placebo-controlled clinical trials, 2396 patients with primary hyperlipidemia (age range 9-86 years, 50% women, 90% Caucasians, 5% Blacks, 3% Hispanics, 2% Asians) and elevated LDL-C were treated with ezetimibe 10 mg/day for a median treatment duration of 12 weeks (range 0 to 39 weeks).
Adverse reactions led to discontinuation of treatment in 3.3% of ezetimibe-treated patients and 2.9% of placebo-treated patients. The most common reasons for ezetimibe treatment discontinuation were arthralgia (0.3%), dizziness (0.2%), and gamma-glutamyltransferase increased (0.2%). Adverse reactions reported in ≥2% of patients treated with ezetimibe and at an incidence greater than placebo in placebo-controlled studies of ezetimibe, regardless of causality assessment, are shown in Table 2.
Table 2. Clinical Adverse Reactions Occurring in ≥2% of Patients Treated with Ezetimibe and at an Incidence Greater than Placebo, Regardless of Causality
| Adverse Reaction | Ezetimibe 10 mg (%) n = 2369 | Placebo (%) N = 1159 |
| Upper respiratory tract infection | 4.3 | 2.5 |
| Diarrhea | 4.1 | 3.7 |
| Arthralgia | 3.0 | 2.2 |
| Sinusitis | 2.8 | 2.2 |
| Pain in extremity | 2.7 | 2.5 |
| Fatigue | 2.4 | 1.5 |
| Influenza | 2.0 | 1.5 |
The frequency of less common adverse reactions was comparable between ezetimibe and placebo.
NEXLIZET
In a 4-arm, 12-week, randomized, double-blind, placebo-controlled, parallel group, factorial trial, 85 patients received NEXLIZET (180 mg of bempedoic acid and 10 mg of ezetimibe) once daily [see Clinical Studies]. The mean age for NEXLIZET-treated patients was 62 years, 51% were women, 12% Hispanic, 78% White, 19% Black, and 2% Asian. At baseline, 61% of patients had clinical atherosclerotic cardiovascular disease (ASCVD) and/or a diagnosis of heterozygous familial hypercholesterolemia. All patients received NEXLIZET plus maximally tolerated statin therapy. Patients taking simvastatin 40 mg/day or higher and patients taking nonstatin lipid-lowering therapy (including fibrates, niacin, bile acid sequestrants, ezetimibe, and PCSK9 inhibitors) were excluded from the trial.
Adverse reactions led to discontinuation of treatment in 8% of patients on NEXLIZET, 5% of patients on placebo, 10% of patients on bempedoic acid, and 12% of patients on ezetimibe. The most common reason for NEXLIZET treatment discontinuation was oral discomfort (2% NEXLIZET versus 0% placebo). 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 (5.9% NEXLIZET versus 2.4% placebo), nasopharyngitis (4.7% NEXLIZET versus 0% placebo), and constipation (4.7% NEXLIZET versus 0% placebo).
Postmarketing Experience
Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following additional adverse reactions have been reported in postmarketing experience for ezetimibe:
Hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria; erythema multiforme; myalgia; elevated creatine phosphokinase; myopathy/rhabdomyolysis; elevations in liver transaminases; hepatitis; abdominal pain; thrombocytopenia; pancreatitis; nausea; dizziness; paresthesia; depression; headache; cholelithiasis; cholecystitis.
Read the entire FDA prescribing information for Nexlizet (Bempedoic acid and Ezetimibe Tablets)
&Copy; Nexlizet Patient Information is supplied by Cerner Multum, Inc. and Nexlizet Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.