LIPFENDRA

LIPFENDRA is an FDA-registered drug product whose active ingredient is LIPFENDRA. It is labelled by Merck Sharp & Dohme LLC taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 0006-5084, application NDA220848, label effective 20260715. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing LIPFENDRA are most often described in connection with: indicated adjunct, exercise reduce, low-density lipoprotein, cholesterol ldl-c, hypercholesterolemia including, heterozygous familial, hefh cardiovascular, outcomes trials. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE LIPFENDRA ® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy. LIPFENDRA is a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody PCSK9 inhibitors as an add-on to statin therapy. ( 1 )

2 DOSAGE AND ADMINISTRATION The recommended dosage of LIPFENDRA is one 20 mg tablet taken orally once daily. ( 2.1 ) Take LIPFENDRA on an empty stomach in the morning with water, black coffee, or plain tea. ( 2.2 ) Swallow the tablet whole. Do not split, crush, or chew the tablet. ( 2.2 ) After taking LIPFENDRA, wait at least 30 minutes before eating food or drinking beverages other than water, black coffee, or plain tea. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of LIPFENDRA is one 20 mg tablet taken orally once daily. Assess LDL-C when clinically appropriate. The LDL-C-lowering effect of LIPFENDRA may be measured as early as 4 weeks after initiation. 2.2 Important Administration Instructions Take LIPFENDRA on an empty stomach in the morning with water, black coffee, or plain tea. Swallow the tablet whole. Do not split, crush, or chew the tablet. After taking LIPFENDRA, wait at least 30 minutes before eating food or drinking beverages other than water, black coffee, or plain tea [see Clinical Pharmacology (12.3) ] . LIPFENDRA can be taken with other medications [see Clinical Pharmacology (12.3) ] . If a dose is missed, take the missed dose as soon as possible, at least 30 minutes before the next food or drink (other than water, black coffee, or plain tea). Do not take 2 doses on the same day.

4 CONTRAINDICATIONS None. None. ( 4 )

6 ADVERSE REACTIONS The frequencies of adverse reactions in adults with hypercholesterolemia were similar between those treated with LIPFENDRA and those receiving placebo. The most common adverse reactions in a study of adults with HeFH treated with LIPFENDRA were diarrhea and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 practice. Adverse Reactions in Adults with Hypercholesterolemia The safety of LIPFENDRA was evaluated in Trial 1 (CORALreef Lipids, NCT05952856), a 52-week, multicenter, double-blind, randomized, placebo-controlled trial in 2,904 patients with hypercholesterolemia (including those with and without HeFH) and a history of a major atherosclerotic cardiovascular disease (ASCVD) event or increased risk for development of a first major ASCVD event [see Clinical Studies (14) ] . In Trial 1, the frequencies of adverse reactions in adults with hypercholesterolemia were similar between those treated with LIPFENDRA and those receiving placebo. Similar proportions of LIPFENDRA-treated patients and placebo-treated patients discontinued treatment because of an adverse reaction. Adverse Reactions in Adults with HeFH The safety of LIPFENDRA was evaluated in Trial 2 (CORALreef HeFH, NCT05952869), a 52-week multicenter, double-blind, randomized, placebo-controlled trial in 303 patients with HeFH [see Clinical Studies (14) ] . In Trial 2, the most common adverse reactions in adults with HeFH treated with LIPFENDRA that occurred at higher frequencies compared to placebo were diarrhea (LIPFENDRA 7%, placebo 2%) and dizziness (LIPFENDRA 9%, placebo 4%). Similar proportions of LIPFENDRA-treated patients and placebo-treated patients discontinued treatment because of an adverse reaction. The safety profile observed in adults with HeFH in Trial 2 was otherwise generally consistent with that observed in adults with hypercholesterolemia in Trial 1.

2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is LIPFENDRA used for?
1 INDICATIONS AND USAGE LIPFENDRA ® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk …

Who makes LIPFENDRA?
Merck Sharp & Dohme LLC is the labeler of record for LIPFENDRA.

What form does LIPFENDRA come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is LIPFENDRA prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has LIPFENDRA been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.