Maralixibat Solution

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.

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Use a specially marked oral syringe, spoon, or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. 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.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

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.

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

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 100 days after opening the bottle.

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.

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

• 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.

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.

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.

This medication contains propylene glycol. This is a substance used in many products to help keep them safe and working well. Large amounts of it can cause problems. The risk is increased in young children and people with kidney or liver problems. It is important to know that other products may also contain propylene glycol. Your care team can help you find information about the ingredients of other products. Talk to your care team right away if you or your child have confusion, unusual weakness or fatigue, headache, trouble breathing, nausea, a fast heartbeat, a decrease in the amount of urine, or seizures.

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.