Maralixibat Tablets

What is this medication?

MARALIXIBAT (MAR a LIX i bat) treats itching caused by liver disease. It works by decreasing the amount of bile acids in the body, which reduces itching.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Livmarli

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Liver disease
• Low levels of vitamin A, D, E, or K in the blood
• An unusual or allergic reaction to maralixibat, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Take it 30 minutes before a meal. Keep taking it unless your care team tells you to stop.

Take bile acid binding resins, such as cholestyramine, colesevelam, or colestipol, at a different time of day than this medication. Take this medication at least 4 hours before or 4 hours after the bile acid resin.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 3 months for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Once daily dosing: If you miss a dose, take it as soon as you can unless it is more than 12 hours late. If it is more than 12 hours late, skip the missed dose. Take the next dose at your normal time. Do not take double or extra doses.

Twice daily dosing: If you miss a dose, take it as soon as you can unless it is more than 6 hours late. If it is more than 6 hours late, skip the missed dose. Take the next dose at your normal time. Do not take double or extra doses.

What may interact with this medication?

• Bile acid resins, such as cholestyramine, colesevelam, colestipol

This medication may affect how other medications work. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medication.

Make sure you get enough vitamins while you are taking this medication. Discuss the foods you eat and the vitamins you take with your care team.

This medication may increase your risk of bone fractures. Tell your care team if you have pain, swelling, or trouble moving a part of your body like you usually can.

Talk to your care team if you may be pregnant. There are benefits and risks to taking medications during pregnancy. Your care team can help you find the option that works for you.

Talk to your care team before breastfeeding. Changes to your treatment plan may be needed.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Dehydration—increased thirst, dry mouth, feeling faint or lightheaded, headache, dark yellow or brown urine
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea
• Stomach pain
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, pour the medication out of the container. Mix it with cat litter, dirt, coffee grounds, or another unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.