Maralixibat is used to treat itching due to liver problems in people with a genetic condition called Alagille syndrome. People with this condition do not have enough ducts to drain a fluid called bile from the liver. This can lead to liver damage when bile builds up in the liver.

Maralixibat treats only liver-related itching. maralixibat is not a treatment or cure for Alagille syndrome.

Maralixibat may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Maralixibat comes as a solution (liquid) to take by mouth. It is usually taken once a day, thirty minutes before the first meal of the day. Take maralixibat at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take maralixibat exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of maralixibat and increase your dose after one week.

Use an oral syringe (measuring device) to accurately measure and take your dose of maralixibat solution. Ask your pharmacist for an oral syringe if one is not included with your medication. Do not use a household teaspoon to measure the solution. Replace each oral syringe after using it for 30 days or if it becomes damaged or hasn't been cleaned. Follow the manufacturer's instructions about how to clean the oral syringe. Ask your doctor or pharmacist if you if you have any questions.

Follow these steps to measure the dose using the syringe provided:

1. Open the bottle by pushing down on the cap and turning the cap at the same time.
2. Push the plunger of the measuring device completely down to the tip.
3. Insert the tip of the measuring device firmly into the opening on the top of the bottle.
4. Turn the bottle (with the measuring device attached) upside down.
5. Pull back on the plunger slowly until the amount of liquid prescribed by your doctor fills the measuring device to the appropriate marking. If you are not sure how to correctly measure the dose your doctor has prescribed, ask your doctor or pharmacist.
6. Turn the bottle (with the measuring device attached) right-side up and slowly remove the measuring device.
7. Take maralixibat directly into your mouth from the measuring device; you should do this while sitting or standing.
8. Replace the cap on the bottle and close tightly.
9. Follow the manufacturer's instructions about how to clean the oral syringe.
10. Call your doctor or pharmacist to find out how you should measure a dose of maralixibat solution if you do not have the measuring device that came with this medication.

Maralixibat controls itching caused by Alagille syndrome but does not cure it. Continue to take maralixibat even if you feel well. Do not stop taking maralixibat without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Maralixibat is usually taken once daily, 30 minutes before a meal. Follow your doctor's dosing instructions very carefully.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

You will need frequent blood tests to check your liver function.

Your doctor may want you to take certain vitamin supplements while you are taking maralixibat. Take only the type and amount your doctor has prescribed.

Store tightly closed at room temperature away from moisture and heat.

Throw away any unused maralixibat liquid 45 days after you first opened the bottle. Ask your pharmacist about a drug take-back program. You may also mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag and throw the bag in the trash.

Tell your doctor if you have ever had cirrhosis.

Maralixibat can make it harder for your body to absorb certain vitamins that you may need more of during pregnancy or while breastfeeding. Follow your doctor's instructions about taking any vitamin supplements if you are pregnant or breastfeeding.

Maralixibat should not be given to a child younger than 1 year old.

Use the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep this medication closed tightly and dispose of any unused medication 45 days after first opening the container.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Maralixibat may cause serious side effects. Call your doctor at once if you have:

• severe ongoing nausea, vomiting, or diarrhea;

• stomach pain, diarrhea that is bloody;

• sudden pain or trouble moving your arm, leg, shoulder, or torso;

• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• dehydration--dizziness, confusion, feeling very thirsty, less urination; or

• stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects of maralixibat may include:

• stomach pain, vomiting, diarrhea;

• stomach bleeding;

• a deficiency in fat-soluble vitamins (vitamin A, D, E, and K); or

• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take your maralixibat dose 4 hours before or 4 hours after taking any of the following:

• colesevelam;

• colestipol; or

• cholestyramine.

Tell your doctor about all your other medicines, especially a "statin" cholesterol medicine such as atorvastatin, simvastatin, lovastatin, rosuvastatin, Crestor, Lipitor, Zocor, and others.

Other drugs may affect maralixibat, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Keep all appointments with your doctor or laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to maralixibat.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking maralixiabat.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.