Maralixibat Oral 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 your first meal of the day. Keep taking it unless your care team tells you to stop.

Take products with bile acid binding resins in them at a different time of day than this medication. Take this medication 4 hours before or 4 hours after these products.

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
• Bloody diarrhea
• 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 45 days after opening.

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

• Take the medication to a medication 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 the medication with cat litter, dirt, coffee grounds, or other 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
• Breast-feeding

• Bile acid binding resins, such as cholestyramine, colesevelam, colestipol
• Certain medications for cholesterol like atorvastatin, lovastatin, simvastatin

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 the normal time.