Why is this medicine prescribed?
Maralixibat is used to treat itching caused by Alagille syndrome (ALGS, a condition in which bile builds up in the liver and damages the liver) and progressive familial intrahepatic cholestasis (PFIC; a liver disease in which bile flow from the liver is blocked) in certain adults and children. Maralixibat is in a class of medications called ileal bile acid transporter inhibitors. It works by decreasing the amount of bile acids in the body.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Maralixibat comes as a solution (liquid) and as a tablet to take by mouth. Take 30 minutes before a meal once or twice a day. Take maralixibat at around the same time(s) every day.
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.
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.
If you are taking the solution, your doctor with give you the manufacturer's instructions for use. These instructions describe how to measure and take a dose of the solution. Read these instructions and follow them carefully. Be sure to ask your pharmacist or doctor if you have any questions.
Maralixibat controls itching caused by Alagille syndrome and progressive familial intrahepatic cholestasis 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.
What special precautions should I follow?
Before taking maralixibat,
- tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking maralixibat. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- if you are taking cholestyramine, colesevelam, or colestipol, take them at least 4 hours before or 4 hours after maralixibat.
- tell your doctor if you have or have ever had any liver problems, including hepatitis or cirrhosis. Your doctor may tell you not to take maralixibat.
- tell your doctor if you have or have ever had any blood clotting problems, malabsorption problems (problems absorbing food or vitamins), osteoporosis (a condition in which the bones are fragile and break easily), osteomalacia (weak bones due to a lack of vitamin D or difficulty absorbing this vitamin), or other conditions that cause weak bones.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking maralixibat, call your doctor.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget to take a dose?
If you are taking maralixibat once a day, take the missed dose as soon as you remember it. However, if it is more than 12 hours since you were supposed to take the dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
What should I do in case of overdose?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What side effects can this medicine cause?
Maralixibat may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- diarrhea
Maralixibat may cause side effects. Some side effects can be serious. If you experience any of these symptoms call your doctor immediately:
- vomiting, decreased urination, dizziness, or headache
- persistent diarrhea; bloody or black, tarry stools; persistent stomach pain; or fever
- skin or the whites of eyes turn yellow, pain on the upper right side of your stomach, nausea or vomiting, loss of appetite, or dark or brown urine
- unusual bleeding or bruising
- vomiting blood
Taking maralixibat may increase the risk that you will experience a bone fracture. Talk to your doctor about the risk of taking this medication and about ways to keep your bones healthy during your treatment.
Maralixibat may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone ( 1-800-332-1088).What should I know about storage and disposal of this medication?
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).
Dispose of any unused maralixibat solution 100 days after first opening the container.
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.What other information should I know?
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.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.