Livmarli (maralixibat) is FDA approved to help with itching caused by liver problems (cholestatic pruritis) from certain genetic conditions. It's for adults and children with Alagille syndrome (ALGS). This medication is also for people 1 year and older with progressive familial intrahepatic cholestasis (PFIC). It works as an ileal bile acid transporter (IBAT) inhibitor. Livmarli (maralixibat) comes as a tablet and a liquid. You take each dose by mouth on an empty stomach. Common side effects include diarrhea and stomach pain.
Livmarli (maralixibat) is an ileal bile acid transporter (IBAT) inhibitor. It blocks IBAT, a protein that normally helps keep bile acid in the body.
People with Alagille syndrome and progressive familial intrahepatic cholestasis have too much bile acid. Bile acids help the body digest and absorb fat. But when there's too much bile acid, it can damage the liver and it's thought to lead to symptoms like itchiness.
By blocking the IBAT protein, Livmarli (maralixibat) works to lower the amount of bile acids in the body. Researchers think this helps relieve itchiness.
| Common Brands | Livmarli |
|---|---|
| Drug Class | Ileal bile acid transporter (IBAT) inhibitor |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
ALGS:
PFIC:
Contact your healthcare provider immediately if you experience any of the following.
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Tips for the Livmarli (maralixibat) liquid:
Livmarli (maralixibat) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Livmarli (maralixibat) has the potential to harm the liver. It can raise your liver enzyme levels, which can be a sign of liver damage.
Before starting Livmarli (maralixibat), you'll need to do a blood test. This helps your prescriber see what your liver health is like before treatment. Then, you'll need regular blood tests during treatment to keep checking your liver.
Get medical help right away if you have symptoms of severe liver damage. Look out for severe nausea, bloody vomit, swelling of your stomach, yellow skin or eyes, and confusion.
Livmarli (maralixibat) often causes diarrhea, stomach pain, and vomiting. If you have diarrhea or vomit, make sure to drink plenty of fluids. These side effects can make you lose too much water from your body and lead to dehydration.
Reach out to your care team if you have diarrhea or stomach pain that won't go away. Also call them if you have bloody diarrhea, diarrhea with vomiting, diarrhea with a fever. And get medical help right away if you have symptoms of severe dehydration. Watch for things like thirst, exhaustion, dizziness, dark urine, and not urinating as much.
The medical team can help manage or treat these side effects. Your prescriber might lower your dose of Livmarli (maralixibat) to help. They could also decide to stop the medication and then restart it at a lower dose once you feel better.
Livmarli (maralixibat) can make your body have a hard time absorbing certain vitamins (A, D, E, and K). Low vitamin levels can sometimes make you more likely to have bleeds or bone fractures.
Before starting Livmarli (maralixibat), your prescriber will check your vitamin levels with a blood test. They'll also check every so often while you're taking the medication. If your levels are low, your prescriber will give you supplements to help bring them back up.
Call your care team if you have any unusual bleeding or if you break a bone while you're taking Livmarli (maralixibat). They can check if it's from low vitamin levels.
The Livmarli (maralixibat) oral solution contains propylene glycol. It's a common additive in some medications.
Although the propylene glycol additive is generally safe, children younger than 5 are at higher risk of toxicity from it. For young children, it's not clear if it's safe to take medications with this additive for a long time. Propylene glycol toxicity can cause serious side effects. This can include seizures or kidney damage.
Your child's prescriber will likely order labs during treatment. This helps them monitor your child's safety with Livmarli (maralixibat). If you're worried about your child's safety, talk to their prescriber.
Bottle of oral solution| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 30ml of 19mg/ml | 1 bottle | $111,946.33 | $111,946.33 |
Your prescriber will find the dose for you based on your body weight.
Alagille syndrome (ALGS) — tablets or 9.5 mg/mL oral solution
Progressive familial intrahepatic cholestasis (PFIC) — tablets or 19 mg/mL oral solution
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Livmarli (maralixibat) will not be safe for you to take.
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Yes, Livmarli does come as a tablet. The tablets are for people with ALGS or PFIC who weigh at least 55 pounds and can swallow pills. For people who have trouble swallowing the tablets, there's a liquid version of the medication for them. Talk to your prescriber about which form of the medication is right for you.
Studies showed that children with ALGS who took Livmarli overall had large improvements in how itchy they felt. In other studies, many had less itchiness after a year or more of treatment compared to when they started the medication. Be sure to follow up with your prescriber about how well Livmarli is working for you.
In studies, people with PFIC who took Livmarli had a lot less itchiness than those who took a placebo. In general, Livmarli started to work within 6 weeks. But it took about 3 months for people to get the full benefits of the medication. Check in with your prescriber about how well Livmarli is working for you.
Diarrhea and vomiting are common side effects of Livmarli. There are a few things you can do to help manage these side effects if they happen. The most important thing is to make sure to stay well hydrated. This helps prevent dehydration, which can be serious if it's severe. Also call your care team if you have these side effects. They might recommend other medications to relieve the specific stomach issue you have. Your prescriber can also consider lowering your Livmarli dose or stopping treatment until these side effects go away.
It's probably a good idea to avoid alcohol while taking Livmarli. This can help prevent further damage to the liver. ALGS and PFIC are genetic conditions that can affect the liver. And, this medication has a risk of harming the liver. What's more, drinking large amounts of alcohol can also damage the liver. Talk to your prescriber about your drinking habits and ask them if you have questions.
It's not clear if Livmarli is safe to take during pregnancy or while breastfeeding. Usually, only a small amount of the medication gets absorbed. But it could still have a risk of lowering vitamin levels. To be safe, talk to your prescriber about the risks and benefits of taking Livmarli during pregnancy. If you're breastfeeding, also check with your baby's pediatrician or primary care provider.
Bylvay (odevixibat) and Livmarli are both used to treat itching from ALGS and PFIC. But the approved ages are different. For ALGS, Livmarli is for people ages 3 months and older and Bylvay is for people ages 1 year and older. It's the opposite for PFIC: Livmarli is used for people ages 1 year and older and Bylvay is for people ages 3 months and older. The medications also come in different forms for people who can't swallow pills. There's a grape-flavored liquid for Livmarli. And for Bylvay, there are oral pellets that you can open and then mix the contents inside with soft food or liquid. Talk to your prescriber to help you compare the medications.
