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Enlicitide: Uses, Side Effects and Dosage

Status:
Prescription (Rx) Facts
Strength:
20 mg
Drug class:
Active ingredient:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Enlicitide

What is LIPFENDRA?

LIPFENDRA is a prescription medicine used along with diet and exercise to reduce bad cholesterol (low-density lipoprotein or LDL-C) in adults with:

  • high cholesterol (hypercholesterolemia).
  • an inherited type of high cholesterol called heterozygous familial hypercholesterolemia (HeFH).

It is not known if LIPFENDRA is safe and effective in children.

Before taking LIPFENDRA, tell your healthcare provider about all of your medical conditions, including if you:

  • are pregnant or planning to become pregnant. It is not known if LIPFENDRA will harm your unborn baby. Tell your healthcare provider if you become pregnant while taking LIPFENDRA.

  • are breastfeeding or plan to breastfeed. You and your healthcare provider should decide the best way to feed your baby if you take LIPFENDRA. You should not take LIPFENDRA and breastfeed without talking to your healthcare provider first.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take LIPFENDRA?

  • Take LIPFENDRA exactly as your healthcare provider tells you to.

  • Take 1 tablet of LIPFENDRA by mouth each morning on an empty stomach 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 you eat or drink anything other than water, black coffee, or plain tea.
  • You can take LIPFENDRA at the same time as you take your other medicines.

  • If you miss a dose:

    • Take it as soon as you remember, 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.
    • Wait at least 30 minutes after taking the missed dose of LIPFENDRA before you eat or drink anything other than water, black coffee, or plain tea.
  • If you take too much LIPFENDRA, call your healthcare provider or the Poison Help line (1-800-222-1222) or go to the nearest hospital emergency room right away. Advice is also available online at poisonhelp.org.

What are the possible side effects of LIPFENDRA?

In people with high cholesterol, the side effects of LIPFENDRA are about the same as in people who are not taking LIPFENDRA. In people with HeFH, the most common side effects of LIPFENDRA are diarrhea and dizziness.

These are not all the possible side effects of LIPFENDRA. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store LIPFENDRA?

  • Store LIPFENDRA at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store LIPFENDRA in the original package (pill bottle) with the lid tightly closed to protect from moisture.
  • The LIPFENDRA bottle has a desiccant (something that absorbs moisture) to keep your medicine dry. Do not remove the desiccant from the bottle.

Keep LIPFENDRA and all medicines out of the reach of children.

General information about safe and effective use of LIPFENDRA

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use LIPFENDRA for a condition for which it was not prescribed. Do not give LIPFENDRA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about LIPFENDRA that is written for health professionals.

What are the ingredients in LIPFENDRA?

Active ingredient: enlicitide decanoate

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The tablet film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent.

Manufactured for: Merck Sharp & Dohme LLC

Rahway, NJ 07065, USA

For patent information: www.msd.com/research/patent .

Copyright © 2026 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights reserved.

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About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 220848 · View the label on DailyMed

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Enlicitide

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class PCSK9 Inhibitor
Active ingredient Enlicitide decanoate 20 mg
Dosage form Tablet, film coated
Route Oral
Marketing status not in the current FDA NDC Directory
Company (applicant) MSD
FDA approval NDA 220848New Drug Application (NDA) Approved July 15, 2026
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
20 mg – 30 in 1 bottle NDC 0006-5084-01
20 mg – 7 in 1 bottle / 1 in 1 carton NDC 0006-5084-58

Source: FDA drug labeling via NLM DailyMed, data as of November 5, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.