Maralixibat

Maralixibat is used to treat itching caused by liver problems in adults and children who are at least 3 months old and have a genetic condition called Alagille syndrome.

Maralixibat is also used to treat itching in some people with progressive familial intrahepatic cholestasis (a genetic disorder) that leads to worsening liver disease in children who are at least 12 months old.

Maralixibat tablet is only for use in adults and children who weigh at least 55 pounds (25 kg).

Maralixibat may also be used for reasons not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time. Use the medicine exactly as instructed.

Your dose may change if you switch to a different strength or form of this medicine. Avoid medication errors by using it exactly as directed on the label or as prescribed by your doctor.

Maralixibat is taken once or twice a day, 30 minutes before a meal. Your doctor will decide your treatment dose and schedule. Follow your doctor's dosing instructions very carefully.

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

Swallow the tablet whole and do not crush, chew, or break it.

Doses are based on your weight. Your dose may change if you gain or lose weight.

Do not change your dose or dosing schedule without your doctor's advice.

You will need regular blood tests before and during treatment with maralixibat. Your treatment may be delayed, reduced, or stopped permanently based on the results.

Your doctor may recommend that you take certain vitamin supplements while you are using maralixibat. Take only the type and amount your doctor has prescribed.

Store at room temperature away from moisture and heat. Discard any unused oral solution 100 days after opening the bottle.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

You should not use maralixibat if you are allergic to it, or if you have or have ever had chronic liver problems, such as internal bleeding, fluid buildup in the stomach, or brain-related issues caused by liver disease.

Tell your doctor if you have or have ever had:

• trouble swallowing;
• a vitamin A, D, E, or K deficiency; or
• liver disease.

You may be more likely to have a broken bone while using maralixibat. Talk with your doctor about ways to keep your bones healthy.

Maralixibat oral solution may contain an ingredient that can cause serious side effects in children younger than 5 years old. Do not give maralixibat to a child without medical advice.

It is not known if maralixibat will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

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

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

• sudden pain or trouble moving your arm, leg, shoulder, or torso;
• nosebleeds, bleeding gums, abnormal vaginal bleeding, or any bleeding that will not stop;
• liver problems--loss of appetite, nausea, vomiting, tiredness, itching, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes);
• dehydration--dizziness, confusion, feeling very thirsty, or urinating less; or
• stomach and intestinal problems--diarrhea, more frequent bowel movements than usual, black, tarry, sticky or bloody stools, or severe stomach pain or tenderness.

Your doctor may change your dose, or your treatments may be delayed or stopped permanently if you have certain side effects.

Common side effects of maralixibat may include:

• stomach pain, vomiting, diarrhea;
• blood in your stools;
• unusual bleeding;
• bone fractures;
• 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 the FDA at 1-800-FDA-1088.

If you take maralixibat once a day: Take the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late. Do not take two doses at the same time.

If you take maralixibat twice a day: Take the medicine as soon as you can, but skip the missed dose if you are more than 6 hours late. Do not take two doses at the same time.

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

Follow your doctor's instructions about any limits on food, drinks, or activities.

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

• colesevelam;
• colestipol; or
• cholestyramine.

This list is not complete. Other drugs may affect maralixibat, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.