Primary hyperlipidemia, including heterozygous familial hypercholesterolemia (as adjunct to diet, in combination with other LDL-C-lowering therapies, or as monotherapy when concurrent LDL-C-lowering therapy is not possible).
To reduce the risk of MI and coronary revascularization in patients who are unable to take recommended statin therapy (including those not taking a statin) and have established cardiovascular disease (CVD) or are at high risk for a CVD event but without established CVD.
Distribution: Some distribution to extravascular tissues.
Metabolism and Excretion: Metabolized in liver to active metabolite (ESP15228); both parent drug and ESP15228 are also metabolized via glucuronidation to inactive metabolites. 70% excreted in urine; 30% excreted in feces primarily as metabolites (<5% excreted as unchanged drug in urine and feces).
Obtain an exercise and diet (saturated fats) history.
Monitor for signs/symptoms of hyperuricemia (gout). May occur within 4 wk of therapy. Initiate therapy with urate-lowering drugs as indicated.
Monitor for signs/symptoms of allergic reactions (anaphylaxis, angioedema) during therapy.
Monitor for signs/symptoms of tendon rupture periodically. May occur within days to months of starting therapy. If joint pain, swelling, or inflammation occur, consider discontinuing bempedoic acid. If tendon rupture occurs, immediately discontinue bempedoic acid.
Lab Test Considerations:
Evaluate serum cholesterol levels before initiating, after 8–12 wk of therapy, and periodically thereafter.
Monitor serum uric acid levels periodically if signs/symptoms of hyperuricemia occur.
Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
Instruct patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care provider before taking any new medications.
Advise patient that this medication should be used in conjunction with diet restrictions (fat, cholesterol, carbohydrates, alcohol), exercise, and smoking cessation.
Advise patient to notify health care provider if signs/symptoms of hyperuricemia (severe foot pain, especially in the toe; tender, warm, red, or swollen joint) occur.
Advise patient to stop therapy, rest, and notify health care provider at the first sign of tendinitis (pain; swelling; tears; inflammation of tendons, including arm, shoulder, or back of ankle) or tendon rupture (hear or feel a snap or pop in a tendon area, bruising right after an injury in a tendon area, unable to move affected area or put weight on affected area).
Advise patient to notify health care provider immediately if signs/symptoms of allergic reactions (swelling of face, lips, mouth or tongue; trouble breathing; wheezing; skin rash, redness, or swelling; severe itching; dizziness or fainting; fast heartbeat) occur.
Rep: May cause fetal harm. Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding.