Nexlizet Generic Name:
Bempedoic acid/Ezetimibe
Nexlizet FDA Approval Date:
February 26, 2020
Nexlizet Dosage Form:
Tablets
Nexlizet Manufacturer / Company:
Esperion Therapeutics
Nexlizet uses:
Treatment for: High Cholesterol, Familial Heterozygous
What is Nexlizet
Nexlizet is FDA approved recently launched medication used to treat high cholesterol levels. It’s especially aimed at adults with conditions like heterozygous familial hypercholesterolemia (HeFH) or heart disease.
Nexlizet is a combination drug made with two active ingredients: bempedoic acid and ezetimibe.
This medication is particularly beneficial for individuals who have not achieved desired cholesterol levels with diet and other cholesterol-lowering treatments.
How Nexlizet Works
Nexlizet stands out because it uses a dual-action approach to lower cholesterol. It combines two active ingredients: bempedoic acid and ezetimibe. Each of these ingredients works in a different way to reduce cholesterol levels, making Nexlizet a powerful tool in cholesterol management.
1. Bempedoic Acid: Slowing Down Cholesterol Production
The first component of Nexlizet, bempedoic acid, targets the liver, which plays a key role in cholesterol production. It works by inhibiting an enzyme called ATP Citrate Lyase. This enzyme is essential for cholesterol synthesis in the liver. By blocking this enzyme, bempedoic acid effectively slows down the liver’s ability to produce cholesterol. This reduction in cholesterol production is a crucial step in lowering overall cholesterol levels in the body.
2. Ezetimibe: Reducing Cholesterol Absorption
The second component, ezetimibe, works differently. It focuses on the intestines, where it blocks a specific transporter called Niemann-Pick C1-Like 1 (NPC1L1). This transporter is responsible for absorbing cholesterol from the diet. By inhibiting NPC1L1, ezetimibe reduces the amount of cholesterol absorbed from the food you eat. This means less dietary cholesterol enters your bloodstream, further helping to lower your total cholesterol levels.
The Combined Effect of Nexlizet
When bempedoic acid and ezetimibe are used together, as in Nexlizet, they offer a comprehensive approach to lowering cholesterol. Bempedoic acid reduces the liver’s cholesterol production, and ezetimibe decreases the amount of cholesterol absorbed from your diet. This dual-action effectively lowers LDL cholesterol (often referred to as ‘bad’ cholesterol) and helps manage cholesterol levels more effectively than either ingredient alone.
Nexlizet Side Effects
Nexlizet isn’t immune to side effects and definitely come with some common and some serious side effects. Although not everyone faces these side effects and results vary from person to person. The most common side effects include:
Common Side Effects
- Symptoms of the Common Cold or Flu: Such as a runny nose, sore throat, or fever.
- Back Pain: Discomfort or pain in the back area.
- Bronchitis: Inflammation of the bronchial tubes, leading to coughing and difficulty breathing.
- Anemia: A condition where you have fewer red blood cells than normal, which can cause tiredness and weakness.
- High Uric Acid Levels: This can lead to gout, a type of arthritis that causes joint pain, especially in the toes.
- Diarrhea: Frequent loose or watery bowel movements.
- Muscle Spasms: Sudden, involuntary muscle contractions.
- Stomach Pain: Discomfort or pain in the abdominal area.
- Pain in the Shoulder, Legs, or Arms: Aching or discomfort in these areas.
- Increased Liver Enzymes: This can indicate liver problems and may require monitoring by your doctor.
- Fatigue: Feeling unusually tired or lacking energy.
Serious Side Effects
While less common, some serious side effects can occur, including:
- Gout: Particularly in people who have had it before. Symptoms include severe foot pain, particularly in the toe joint, swelling, and redness.
- Tendon Rupture or Injury: Tendon problems can happen, especially in people over 60, those taking certain antibiotics (fluoroquinolones), steroids, or those with kidney problems.
Who should not Use Nexlizet or use Precautions
Nexlizet may not be suitable for everyone. Here are some key groups of people who should either not use Nexlizet or use it with caution:
People with a Known Allergy: Anyone who has a known allergy to bempedoic acid, ezetimibe, or any other component of Nexlizet should avoid using this medication.
Pregnant Women: The safety of Nexlizet during pregnancy has not been established. Women who are pregnant or planning to become pregnant should discuss the risks and benefits of Nexlizet with their healthcare provider.
Breastfeeding Mothers: It is not clear whether Nexlizet passes into breast milk. Nursing mothers should consult their healthcare provider to weigh the potential risks and benefits before taking this medication.
Individuals with Liver Problems: Since Nexlizet can affect liver enzymes, those with pre-existing liver conditions should use this medication cautiously. Regular monitoring of liver function might be necessary.
People with Severe Kidney Disease: Patients with severe renal impairment may need to be cautious, as the medication could potentially worsen their condition.
Older Adults, Especially Over 60: Older adults, particularly those over 60, may have an increased risk of tendon rupture or injury when using Nexlizet. This risk may be higher in those taking certain types of antibiotics or steroids.
Patients with a History of Gout: Since Nexlizet can increase uric acid levels, individuals with a history of gout should be cautious, as the medication could trigger gout attacks.
Individuals Taking Certain Other Medications: Nexlizet can interact with other medications, which might increase the risk of side effects or reduce the effectiveness of either Nexlizet or the other drugs. Patients should inform their healthcare provider about all medications they are taking.
People with Tendon Problems: Patients with a history of tendon issues should use Nexlizet with caution due to the risk of tendon rupture.
Nexlizet vs Muscle Spasm
Muscle spasms are involuntary contractions of a muscle. They can be caused by a variety of factors including muscle fatigue, dehydration, electrolyte imbalances, and certain medical conditions.
The relationship between Nexlizet and muscle spasms would typically be in the context of potential side effects, although this isn’t extremely common. Like many medications, Nexlizet can have side effects, and muscle-related symptoms (like muscle spasm, pain, or weakness) could potentially be among them.
Why Nexlizet causes Muscle Spasms
Let’s dive deeper into the conditions caused by the drug and figure out exactly why nexlizet causes muscle spasm:
Direct Muscle Effects: Bempedoic acid, one of the components of Nexlizet, inhibits an enzyme called ATP citrate lyase, which is involved in cholesterol synthesis. This inhibition can potentially interfere with muscle function or metabolism, leading to muscle spasms.
Electrolyte Imbalance: Any medication affecting metabolism can potentially disrupt electrolyte balance. Electrolytes are crucial for muscle function, and imbalances can lead to muscle spasms.
Statins and Muscle Symptoms: Although Nexlizet does not contain statins, it is often used in combination with statin therapy for cholesterol management. Statins are known to cause muscle-related side effects in some people, and when used in combination with Nexlizet, these effects might be more pronounced.
Individual Susceptibility: Some individuals may have a genetic or metabolic predisposition to experiencing muscle-related side effects from certain medications, including Nexlizet.
Why Nexlizet causes elevations in Serum Uric Acid levels?
Nexlizet, which contains bempedoic acid and ezetimibe, is known to potentially cause elevations in serum uric acid levels in some patients. This increase in uric acid can be attributed to the specific mechanisms of action of bempedoic acid, one of the components of Nexlizet:
Inhibition of ATP Citrate Lyase: Bempedoic acid works by inhibiting an enzyme called ATP citrate lyase, which plays a role in cholesterol synthesis. This enzyme is also involved in energy metabolism pathways in the body. When ATP citrate lyase is inhibited, it can lead to alterations in various metabolic processes, including those that influence uric acid levels.
Purine Metabolism: Uric acid is a byproduct of purine metabolism. Changes in metabolic pathways due to the action of bempedoic acid might influence the rate or extent of purine metabolism, leading to increased production or decreased excretion of uric acid.
Kidney Function: Bempedoic acid may impact kidney function or the kidneys’ ability to excrete uric acid. A reduction in the rate of uric acid excretion can lead to higher levels in the blood.
Interaction with Other Metabolic Pathways: Bempedoic acid’s role in cholesterol and lipid metabolism might indirectly affect other pathways, including those involved in uric acid production and excretion.
Elevations in serum uric acid can be a concern because high levels might lead to gout, a form of inflammatory arthritis. If someone taking Nexlizet experiences an increase in uric acid levels, a healthcare provider might monitor the condition, adjust the medication dosage, or recommend additional treatments to manage uric acid levels.
Nexlizet Cost
The cost of Nexlizet varies depending on the source and whether discounts or coupons are applied. Prices range from around $4.00 to $12.74 per tablet, with a typical cost of about $426 for a supply of 30 tablets.
AWP (Average Wholesale Price) for Nexlizet is $475.15
Nexlizet Coupon
A Nexlizet Co-Pay Card is available from manufacturer, allowing eligible patients to pay as little as $10 per prescription fill. This offer is applicable to those with commercial drug insurance.
Nexlizet $10 Coupon Eligibility
To be eligible for the Nexlizet Co-Pay Card, which allows patients to pay as little as $10 per prescription fill, the following criteria must be met:
- The patient must be at least 18 years of age.
- The patient must have a valid prescription for Nexlizet.
- The patient must have commercial prescription drug insurance.
- The patient must be a resident of the United States, including the District of Columbia but excluding territories like Puerto Rico and the US Virgin Islands.
- The patient must not be enrolled in any state, federal, or government-funded healthcare program, such as Medicare, Medicaid, Medigap, TRICARE of the Department of Defense, or the Department of Veterans Affairs healthcare program.
It’s important to note that patients covered by federal or state healthcare programs are not eligible for co-pay assistance due to regulatory reasons.
If a patient’s insurance coverage changes or they become enrolled in a Government Program during their enrollment in the Nexlizet Co-Pay Card program, they must inform a program representative and will no longer be eligible for the Co-Pay Card program.
Nexlizet Strength
Nexlizet 180 10 mg tablet
NDC: 72426-0818-03
Tablet Color: Blue
Tablet Shape: Oval
Tablet Imprint: 818 ESP
Foods to Avoid on Nexlizet
While taking Nexlizet, there are no specific foods that you must avoid. However, it is generally recommended to follow a cholesterol-lowering diet while on this medication. This may include eating fewer calories and a low-fat diet, which can contribute to weight loss and overall cholesterol management. It’s important to maintain a balanced and healthy diet and consult with your healthcare provider for personalized dietary advice. For detailed information on Nexlizet, including dietary recommendations, visit our weight loss section.
Dosage and Administration of Nexlizet
• Administer one tablet (180 mg bempedoic acid and 10 mg ezetimibe)
orally once daily with or without food.
• Swallow the tablet whole (Do not cut, chew, or crush the tablet.)
• If you are co-administrating Nexlizet tablet with Bile Acid Sequestrants, then administer at least
2 hours before or at least 4 hours after bile acid sequestrants. Get a complete list of Bile acid sequestrants here.
Nexlizet Package Insert
Nexlizet Interactions
Understanding Nexlizet’s potential drug interactions is crucial for optimizing its use and ensuring patient safety.
Simvastatin:
- Clinical Impact: Using Nexlizet with simvastatin increases simvastatin levels in the blood. This heightened concentration may raise the risk of simvastatin-related myopathy.
- Caution: It is advised to avoid using Nexlizet with more than 20 mg of simvastatin to prevent potential muscle-related issues.
Pravastatin:
- Clinical Impact: Similarly, concurrent use with pravastatin leads to increased pravastatin levels, elevating the risk of pravastatin-related myopathy.
- Caution: Limit the use of Nexlizet with pravastatin doses above 40 mg.
Cyclosporine:
- Clinical Impact: When used with cyclosporine, Nexlizet increases the concentrations of both ezetimibe and cyclosporine.
- Caution: Regular monitoring of cyclosporine levels is essential. The risks and benefits of this combination should be carefully assessed, especially in patients already receiving cyclosporine.
Fibrates:
- Clinical Impact: Co-administration with fibrates, particularly fenofibrate, might increase the risk of cholelithiasis due to increased cholesterol excretion into the bile.
- Caution: Monitor patients for signs of gallbladder issues. Consider alternative lipid-lowering therapies if cholelithiasis is suspected.
Cholestyramine:
- Clinical Impact: Cholestyramine usage alongside Nexlizet can reduce ezetimibe concentrations, potentially diminishing Nexlizet’s efficacy.
- Caution: To maintain effectiveness, Nexlizet should be administered either at least 2 hours before or 4 hours after taking bile acid sequestrants like cholestyramine.
Nexlizet Overdose
An overdose of Nexlizet can potentially lead to serious health implications. While the specific effects of a Nexlizet overdose may vary depending on the amount taken and individual patient factors, it’s crucial to understand the general risks and appropriate responses. Some of the symptoms include:
Muscle-related Symptoms:
Given that both components of Nexlizet can affect muscle tissue, an overdose may exacerbate muscle-related side effects like pain, weakness, or even more severe conditions like myopathy.
Liver Function Impairment:
Elevated doses might increase the risk of liver enzyme elevations, which could indicate liver damage or dysfunction.
Gastrointestinal Distress:
Overdosing may lead to gastrointestinal issues such as nausea, vomiting, diarrhea, or abdominal pain.
Electrolyte Imbalance and Kidney Function:
High doses could potentially disrupt electrolyte balance and affect kidney function, given the drug’s metabolic pathways.
Nexlizet Overdose – What you can do?
- Seek Emergency Medical Attention: In case of an overdose, immediate medical attention is essential. Contact emergency services or call 911.
- Symptomatic and Supportive Care: Treatment mainly involves managing the symptoms and providing supportive care. This may include monitoring vital signs, liver and kidney function, and addressing any specific symptoms that arise.
- No Specific Antidote: Currently, there is no specific antidote for Nexlizet overdose. Treatment focuses on symptomatic relief and supportive measures.
Nexlizet Alternative
If you’re looking for alternatives to Nexlizet for managing cholesterol levels, there are several options available depending on individual health profiles and specific treatment goals. Here are some common alternatives:
Statins: This is the most widely prescribed class for lowering cholesterol. Statins work by inhibiting the enzyme HMG-CoA reductase in the liver, which is responsible for producing cholesterol. Examples include atorvastatin, simvastatin, rosuvastatin, and pravastatin.
Ezetimibe: While this is one of the components of Nexlizet, ezetimibe can also be used alone. It works by reducing the amount of cholesterol absorbed in the intestines.
PCSK9 Inhibitors: These are relatively new and are used for patients who have genetic conditions leading to high cholesterol or for those who cannot tolerate statins. Examples include alirocumab and evolocumab.
Bile Acid Sequestrants: These drugs work by binding to bile acids, leading to their excretion. This forces the liver to use more cholesterol to make more bile acids, thereby lowering cholesterol levels. Examples are cholestyramine, colestipol, and colesevelam.
Niacin (Nicotinic Acid): Niacin can lower both LDL (bad) cholesterol and triglycerides and raise HDL (good) cholesterol. However, it can have significant side effects and is generally used as a secondary treatment.
Fibrates: Primarily used to lower triglycerides, they can also have a modest effect on increasing HDL cholesterol. Examples include fenofibrate and gemfibrozil.
Omega-3 Fatty Acids: These are natural supplements that can help lower triglyceride levels. They are available over the counter and by prescription.
Lifestyle Changes: Often, the first line of defense against high cholesterol includes dietary modifications, increased physical activity, smoking cessation, and weight management.
Each alternative has its own profile of effectiveness, side effects, and interactions.
Questions & Answers on Nexlizet cholesterol lowering drug
How to take Nexlizet / Directions to use
Timing: Nexlizet is typically taken once daily usually at the same time each day to maintain an even level of the medication in your body.
With or Without Food: Nexlizet can be taken with or without food. Choose a routine that is easiest for you to remember and stick to it.
Swallow Whole: The tablets should be swallowed whole and not crushed, chewed, or broken.
Consistency: Consistency in taking your medication is key. Do not skip doses or stop taking the medication without consulting with your provider.
Lifestyle Modifications: Along with medication, follow any lifestyle changes recommended by your healthcare provider, such as diet, exercise, and weight control.
What to do when you Miss a Dose of Nexlizet:
If you miss a dose, take it as soon as you remember. However, if it’s nearly time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Is Nexlizet Safe?
Nexlizet is generally considered safe for its approved use, which is to help lower LDL cholesterol levels in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease. However, like all medications, its safety and appropriateness depend on individual patient factors, including overall health, other medical conditions, and concurrent medications.
Safety Profile of Nexlizet:
Clinical Trials: Nexlizet has undergone clinical trials that demonstrated its efficacy and safety for lowering cholesterol levels when used as directed.
FDA Approval: It received approval from the U.S. Food and Drug Administration (FDA), indicating that it has met standards for safety and effectiveness.
Side Effects: Common side effects may include upper respiratory tract infections, muscle spasms, back pain, abdominal pain, bronchitis, anemia, and elevated liver enzymes. These are typically mild side effects.
Why is Nexlizet so expensive
The high cost of Nexlizet, like many prescription medications, can be attributed to several factors. Here are some key reasons for its high cost:
Brand Name and Lack of Generic Alternatives: Nexlizet is a brand-name drug, and as of now, there is no generic version available. Brand-name drugs are often more expensive than their generic counterparts due to the costs associated with research, development, and marketing.
Research and Development Costs: The development of new drugs involves significant investment in research and clinical trials. These costs often get factored into the pricing of the medication once it reaches the market.
Manufacturing and Quality Control: Producing medications that meet strict regulatory standards involves complex manufacturing processes and rigorous quality control, which can add to the cost.
Market Factors: Pricing can also be influenced by market dynamics, including demand for the drug, competition, and the drug’s perceived value in terms of its effectiveness and innovation.
Insurance Coverage and Rebates: The actual out-of-pocket cost for Nexlizet can vary depending on one’s health insurance coverage. Additionally, manufacturer coupons, copay cards, or patient assistance programs may be available to help reduce the cost for eligible patients.
Is Nexlizet a Statin?
No, Nexlizet is not a statin medication. It is used to help lower cholesterol levels, but it works differently from statins. Nexlizet contains two medicines, bempedoic acid and ezetimibe, that help lower LDL (“bad”) cholesterol in different ways: bempedoic acid reduces cholesterol production in the liver, and ezetimibe lowers cholesterol absorption from the intestines.
Can you take Nexlizet with Statin?
Yes, Nexlizet can be taken with a statin. In fact, Nexlizet is often prescribed as an adjunct to diet and maximally tolerated statin therapy for the treatment of hypercholesterolemia.
How should I store Nexlizet?
- To store Nexlizet properly, keep it at room temperature, ideally between 68°F and 77°F (20°C to 25°C).
- It’s important to protect it from heat and moisture, so don’t remove the desiccant packet from the bottle as it helps keep the medicine dry.
- Nexlizet bottles have child-resistant caps for safety. Always ensure that
- Nexlizet and all other medicines are stored out of reach of children.
What are the ingredients in Nexlizet?
- Nexlizet is composed of two main active ingredients that lower cholesterol: bempedoic acid and ezetimibe.
- Besides these, it contains several inactive components that give the tablet its form and consistency. These include substances like colloidal silicon dioxide and lactose monohydrate for structure, magnesium stearate for smoothness, and sodium starch glycolate.
- The tablet’s outer coating is made of various colorants like FD&C Blue dyes and titanium dioxide, along with other compounds to create the coating texture. These ingredients are common in many tablet formulations and are used to ensure the stability and effectiveness of the medication.
Nexlizet Reviews
Based on certain findings on breakthrough drug Nexlizet, some reputable sites provided the following ratings:
- Average ratings 3.8 out of 5.
- Ease of use got a rating of 4.0
- Effectiveness received a slightly lower rating of 3.4.
These reviews provide insights into the real-world experiences of individuals taking Nexlizet, but it’s important to remember that individual experiences with medications can vary greatly.