Lipfendra: Indications for Use, How to Take It & Side Effects

Lipfendra is a prescription medicine used to lower low-density lipoprotein cholesterol, commonly called LDL or “bad” cholesterol. It contains enlicitide, previously known as MK-0616, and belongs to a group of medicines called PCSK9 inhibitors.

Unlike other PCSK9 inhibitors that are given by injection, Lipfendra is available as a once-daily oral tablet. It works by blocking PCSK9, a protein that reduces the liver’s ability to remove LDL cholesterol from the blood.

Lipfendra is used together with a cholesterol-lowering diet and regular physical activity. Other cholesterol medicines, such as statins, may also remain part of treatment depending on the person’s cholesterol levels and cardiovascular risk.

Man taking medication

Indications for use

Lipfendra is indicated as an addition to diet and exercise to reduce LDL cholesterol in adults with hypercholesterolemia, which means high cholesterol levels in the blood.

It may be prescribed for adults with different forms of hypercholesterolemia, including heterozygous familial hypercholesterolemia, or HeFH. HeFH is an inherited condition that causes very high LDL cholesterol levels and increases the risk of early cardiovascular disease.

Lipfendra may be considered when LDL cholesterol remains above the recommended level despite diet, exercise and other cholesterol-lowering treatments. The medicine may be used alongside statins or other therapies when additional LDL reduction is needed.

How Lipfendra works

PCSK9 is a protein that attaches to LDL receptors on liver cells. These receptors normally remove LDL cholesterol from the bloodstream.

Lipfendra binds to PCSK9 and prevents it from interfering with LDL receptors. This allows more receptors to remain available on the liver’s surface, helping the liver remove more LDL cholesterol from the blood.

How to take it

The recommended Lipfendra dose is one 20 mg tablet taken by mouth once daily.

The tablet should be taken in the morning on an empty stomach. It may be taken with water, plain black coffee or plain tea.

Food and other beverages should be avoided for at least 30 minutes after taking the medicine. Following these instructions is important because food may affect how the medicine is absorbed.

The tablet should be swallowed whole. It should not be split, crushed or chewed.

Treatment is generally continued daily for as long as cholesterol-lowering therapy is needed. The duration of treatment is determined by the prescribing health care professional based on LDL cholesterol levels, treatment response, other medical conditions and overall cardiovascular risk.

Possible side effects

The most commonly reported side effects include diarrhea and dizziness.

Serious side effects and treatment discontinuations were uncommon in earlier clinical trials. However, Lipfendra is a newly approved medicine, and additional side effects may become known as it is used by a larger number of people.

Medical assessment is recommended when a side effect is severe, persistent or accompanied by other concerning symptoms.

Contraindications

There are no formal contraindications for Lipfendra listed in current prescribing information.

However, the absence of a listed contraindication does not mean that the medicine is suitable for every person. A complete medical and medication history should be reviewed before treatment begins, particularly when pregnancy, breastfeeding, liver disease, kidney disease or the use of other medicines is involved.