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Overview: Livmarli is used to treat itching caused by Alagille syndrome (ALGS) or progressive familial intrahepatic cholestasis (PFIC), which are genetic conditions that can cause liver damage due to bile buildup. Livmarli works by reducing the amount of bile acid (a component of bile) circulating in the body. Common side effects include stomach and intestinal problems, a lack of vitamins, abnormal liver test results, and bone fractures. Serious side effects include liver damage.

Uses

What is Livmarli used for?

Livmarli (maralixibat) is commonly used to treat itching caused by the following conditions:

  • Alagille syndrome (ALGS), a genetic condition linked to liver and heart problems due to abnormal bile ducts (the ducts that carry bile from the liver) and poor blood flow between the heart and the lungs
  • Progressive familial intrahepatic cholestasis (PFIC), a genetic condition in which the liver can’t release bile (a fluid made in the liver that helps with digestion), which eventually leads to bile buildup and liver damage

Livmarli may also be used for other conditions as determined by your health care provider.

How does Livmarli work (mechanism of action)?

Livmarli reduces the amount of bile acid (a component of bile) that is returned to your blood from your intestines. This reduces the amount of bile acid that circulates between your blood and your liver, which may help manage the symptoms of ALGS and PFIC caused by bile buildup in the liver.

How is Livmarli supplied (dosage forms)?

Brands and other names

  • Livmarli

Dosage forms and strengths

  • 9.5 mg/mL oral solution
  • 19 mg/mL oral solution

How should I store Livmarli?

Livmarli should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when you’re transporting it. Store it in a cool, dry place. After opening the bottle, throw away any remaining Livmarli after 100 days.

Side Effects

What are the most common side effects of Livmarli?

The most common side effects of Livmarli are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Stomach and intestinal problems, including pain, diarrhea, vomiting, or blood in stools (see below)
  • Vitamin deficiency (see below)
  • Abnormal liver test results
  • Bone fractures

There may be other side effects of Livmarli that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Livmarli?

While less common, the most serious side effects of Livmarli are described below, along with what to do if they happen.

Severe Allergic Reactions. Livmarli may cause allergic reactions, which can be serious. Stop taking Livmarli and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown, depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Livmarli. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Stomach and Intestinal Problems. Livmarli can cause problems in your stomach and intestines, including diarrhea and stomach pain. Persistent diarrhea or stomach pain may require close examination and treatment. Tell your health care provider if you have any of the following symptoms.

  • Diarrhea or stomach pain that doesn’t go away
  • Vomiting
  • Blood in your stools
  • Dizziness, headache, or decreased amount of urine (These may be signs of dehydration.)

Vitamin Deficiency. Livmarli may cause you to lack vitamins A, D, E, and K because it affects how your body absorbs fat. Deficiency of these vitamins can increase your risk of bone fractures or abnormal bleeding. Tell your health care provider if you have any bone fracture or bleeding while taking Livmarli.

Propylene Glycol Toxicity. Propylene glycol, one of the ingredients of Livmarli, can be toxic at higher doses. The risk is the highest in children who are younger than 5 years of age. Propylene glycol toxicity can damage your kidneys, red blood cells, and your nervous system. Tell your health care provider right away if you or your child has any of the following symptoms of propylene glycol toxicity.

  • Reduced need to pee
  • Swelling in your feet, ankles, or legs
  • Weakness or unusual tiredness
  • A hard time catching your breath or chest pain/pressure
  • Confusion, dizziness, or lightheadedness
  • Nausea
  • Seizures
  • Pale or yellowish skin
  • Headache
  • Problems concentrating

Warnings & Precautions

Who should not use Livmarli?

Allergies to Ingredients. People who are allergic to any of the following should not take Livmarli.

  • Maralixibat
  • Livmarli
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific Livmarli products they stock.

Liver Problems. Livmarli should not be used if you have an active liver problem or have had a severe liver problem in the past. If there is a concern about the health of your liver, your health care provider may do tests to find out if it is working well enough for you to take this medicine.

What should I know about Livmarli before using it?

Do not take Livmarli unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Livmarli with other people, even if they have the same condition as you. It may harm them.

Keep Livmarli out of the reach of children.

Use an accurate measuring device to measure your dose. A household spoon is not an accurate measuring device and may cause you to take the wrong dose. Ask your pharmacist to recommend a good measuring device.

What should I tell my health care provider before using Livmarli?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Livmarli is right for you.

In particular, make sure that you discuss any of the following.

Vitamin Deficiency. Tell your health care provider if you have any vitamin deficiency. Livmarli may cause a lack of vitamin A, D, E, or K to get worse.

Other Medicines and Supplements. Livmarli may interact with other medicines and supplements. Before taking Livmarli, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Livmarli could affect pregnancy or harm an unborn baby. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. It is not known if Livmarli passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take Livmarli while breastfeeding.

How can I get more information about Livmarli?

For more information about Livmarli, you can visit the drugmaker’s website at livmarli.com or call them at 650-667-4085.

Interactions

Does Livmarli interact with foods or drinks?

Livmarli should be taken 30 minutes before a meal.

It is unknown if drinking alcohol will affect Livmarli.

Does Livmarli interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any bile acid sequestrant, such as cholestyramine (Prevalite), colesevelam (Welchol), or colestipol (Colestid), which is a medicine to lower cholesterol. Livmarli should be taken at least four hours before or four hours after taking these medicines.

Livmarli may alter the blood levels of some other medicines. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Livmarli. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Livmarli?

If you or someone else has used too much Livmarli, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Livmarli?

If you're taking Livmarli once a day and you miss a dose, and it's 12 hours or less from the time you usually take your dose, take the missed dose as soon as you remember. But if more than 12 hours have passed from the time you usually take your dose, skip the missed dose and only take the next dose. Do not take double or extra doses.

If you're taking Livmarli twice a day and you miss a dose, and it's six hours or less from the time you usually take your dose, take the missed dose as soon as you remember. But if more than six hours have passed from the time you usually take your dose, skip the missed dose and only take the next dose. Do not take double or extra doses.