Maralixibat (mar-a-LIX-i-bat)

Treats skin itching in patients with Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC).

Brand Name(s):

Livmarli

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid

• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Measure the oral liquid medicine with the provided dosing dispenser.
• Take this medicine at least 30 minutes before the first meal of the day.
• Check the liquid in the bottle. It should be clear to almost clear and colorless to light yellow. Do not use the medicine if the liquid is discolored, or has particles in it.
• To use:
  • Write the date on the bottle when you first opened the medicine. Remove the plastic seal.
  • Open the bottle by pushing down on the child-resistant cap and turn the cap to the left (counter-clockwise).
  • If you are using a new dosing dispenser, remove it from the wrapper. If you are using a used dosing dispenser, make sure that it has been cleaned. Remove and throw away the cap of the dosing dispenser, if applicable.
  • Measure the oral liquid medicine with the provided dosing dispenser. Make sure to use the correct dosing dispenser depending on the prescribed dose.
  • Push the plunger down fully to remove air from the dispenser. Once the cap of the bottle is removed, insert the tip of the dispenser into the bottle. The tip should fit into the hole. Check for air bubbles. If you see any, push the plunger so that the medicine flows back into the bottle.
  • Keep the dosing dispenser in place and turn the bottle upside down. Pull back the plunger slowly until the top of the plunger is even with the marking on the barrel of the dosing dispenser.
  • Remove the dosing dispenser from the bottle by pulling straight up on the barrel. Place the tip of the dispenser against the inside of the cheek and slowly push the plunger all the way to give the entire dose.
  • Swallow the whole dose. If you are not sure the full dose was swallowed, do not give another dose. Wait until the next scheduled dose.
• Missed dose:
  • Once a day dosing: If it has been 12 hours or less, take it as soon as possible, and then go back to your regular schedule. If it has been more than 12 hours, do not take an extra dose. Take the next dose at the regular scheduled time. Do not take extra medicine to make up for the missed dose.
  • Two times a day dosing: If it has been 6 hours or less, take it as soon as possible, and then go back to your regular schedule. If it has been more than 6 hours, do not take an extra dose. Take the next dose at the regular scheduled time. Do not take extra medicine to make up for the missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store this medicine with the cap on the bottle.
• Throw away any unused medicine 100 days after opening the bottle.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Take this medicine at least 4 hours before or 4 hours after using bile acid sequestrants (including cholestyramine, colesevelam, colestipol).

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have fat-soluble vitamin (vitamins A, D, E, and K) deficiency.
• This medicine may cause the following problems
  • Liver problems
  • Stomach or bowel problems, including diarrhea, stomach pain, or vomiting
  • Bone fracture
  • Bleeding problems
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Black, tarry stools, constipation, vomiting of blood or material that looks like coffee grounds
• Bone fractures
• Dark urine, pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Severe diarrhea
• Unusual bleeding

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088