Do not take NEXLETOL if you are allergic to bempedoic acid or any of the ingredients in NEXLETOL. If you have any of the following signs and symptoms of a serious allergic reaction call your healthcare provider or go to the nearest hospital emergency room:
• swelling of your face, lips, mouth, or tongue
• trouble breathing
• wheezing
• skin rashes, redness, or swelling
• severe itching
• dizziness or fainting
• fast heartbeat or pounding in your chest
What should I tell my healthcare provider before taking NEXLETOL?
Tell your healthcare provider if you:
• have, or had, gout
• have, or had, tendon problems
• are pregnant or breastfeeding or may become pregnant or plan to breastfeed. It is not known if NEXLETOL passes into your breastmilk
• have severe kidney or severe liver problems
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your healthcare provider if you take or plan to take simvastatin or pravastatin, as taking either with NEXLETOL may increase your risk of developing muscle pain or weakness.
What is the most important safety information I should know about NEXLETOL?
NEXLETOL can cause serious side effects, including:
• increased levels of uric acid in the blood, which can lead to gout. Call your doctor if you have any of the following symptoms: severe foot pain especially in the toe joint, warm joints, swelling, tender joints or joint redness.
• tendon rupture or injury. Tendon problems can happen in people who take NEXLETOL. The risk of getting tendon problems while you take NEXLETOL is higher if you: are over 60 years of age, are taking steroids, are taking antibiotics called fluoroquinolones, have renal failure, or have had tendon problems in the past. Stop taking NEXLETOL immediately and get medical help if you experience signs of tendon rupture such as snap or pop in tendon area, bruising after an injury in a tendon area, or unable to move or put weight on the affected area.
The most common side effects of NEXLETOL in people with primary hyperlipidemia include symptoms of the common cold or flu-like symptoms, muscle spasms, back pain, stomach pain, bronchitis, pain in shoulder, legs, or arms, anemia and increased liver enzymes.
The most common side effects of NEXLETOL in people with heart problems include kidney problems, anemia, increased liver enzymes, muscle spasms, and gallstones.
These are not all the possible side effects of NEXLETOL. Ask your healthcare provider or pharmacist for more information.
What is NEXLETOL?
NEXLETOL is a prescription medicine used:
• to lower the risk of heart attack and heart procedures like stent placement or bypass surgery, in adults who are unable to take recommended statin treatment (a cholesterol-lowering medicine), or are not taking a statin, who:
- have known heart disease, or
- are at high risk for heart disease but without known heart disease.
• along with diet and other cholesterol-lowering medicines, or alone when use with other cholesterol-lowering medicines is not possible, to reduce low-density lipoprotein (LDL or bad cholesterol) in adults with high blood cholesterol levels called primary hyperlipidemia, including a type of high blood cholesterol called heterozygous familial hypercholesterolemia (HeFH).
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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