maralixibat

What is the most important information I should know about maralixibat?

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

What is maralixibat?

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. This medicine is not a treatment or cure for Alagille syndrome.

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

What should I discuss with my healthcare provider before taking maralixibat?

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.

How should I take maralixibat?

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.

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.

What happens if I miss a dose?

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.

What happens if I overdose?

What should I avoid while taking maralixibat?

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

What are the possible side effects of maralixibat?

• 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 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.

What other drugs will affect maralixibat?

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.

Where can I get more information?

Your pharmacist can provide more information about maralixibat.