INSTRUCTIONS FOR USE LIVMARLI® [liv-MAR-lee] (maralixibat) oral solution
This Instructions for Use contains information on how to take LIVMARLI. Read this Instructions for Use before you start taking LIVMARLI for the first time and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. LIVMARLI is available in two strengths: • LIVMARLI 9.5 mg/mL is for the treatment of Alagille Syndrome. • LIVMARLI 19 mg/mL is for the treatment of Progressive Familial Intrahepatic Cholestasis.
Follow your healthcare provider's instructions for the dose of LIVMARLI to give.
Ask your healthcare provider or pharmacist if you have questions about how to prepare or give the prescribed dose of LIVMARLI.
	Important information about measuring LIVMARLI
• Before you give LIVMARLI for the first time, talk to your healthcare provider or pharmacist about how to correctly measure your prescribed dose. • You may be given 1 or more dosing dispensers of different sizes as shown in Table 1 below. Always use the correct dosing dispenser size provided with LIVMARLI based on your current prescribed dose.
	Table 1
	Dose (mL)	Dosing dispenser size (mL)
	0.1 to 0.5	0.5
	0.6 to 1	1
	1.25 to 3	3
• Your prescribed dose may change over time. Use the table above to choose the correct dosing dispenser size for your prescribed dose. • If you do not have the correct dosing dispenser size for your prescribed dose, contact your healthcare provider or pharmacist. • The dosing dispenser may be used for 100 days if cleaned correctly (see Section C). After 100 days, replace the dosing dispenser with a new one. A new replacement dosing dispenser may be used within the 100 days if necessary. • Do not use a household teaspoon or any other dosing device to measure the dose. • Do not open more than 1 bottle of LIVMARLI at a time. • Do not give more than the prescribed dose. • Do not use LIVMARLI after 100 days of first opening the bottle or after the throw away (discard) date listed on the pharmacy label (see Section D). • When you start a new bottle of LIVMARLI, use a new dosing dispenser.
	Storage information
• Store unopened LIVMARLI at room temperature, between 68°F and 77°F (20°C and 25°C). • After opening the LIVMARLI bottle, store below 86°F (30°C) and throw away (discard) any remaining LIVMARLI after 100 days. • Store the dosing dispenser in a clean, dry place when not in use. Keep LIVMARLI and all medicines out of the reach of children.
	You will receive
LIVMARLI oral solution
Each package of LIVMARLI contains:
	LIVMARLI (9.5 mg/mL or 19 mg/mL):
Dosing dispensers, provided separately by your pharmacist:

	Note: Dosing dispenser sizes shown are for example only.
	Section A: Prepare the bottle
	1. Remove the LIVMARLI bottle from the box (See Figure A).
	Note: The LIVMARLI bottle may not be in a box.
	Figure A
	2. Write the date (bottle open date) on the LIVMARLI bottle (See Figure B).
	Note: The date of first opening or a throw away (discard) date may already be written on the bottle label by your pharmacist.
	Figure B
	3. Remove the plastic seal from the bottle (See Figure C).
	Note: Your pharmacist may have already removed the plastic seal from the bottle.
	Figure C
	Section B: Prepare and give LIVMARLI
Step 1: Draw the dose
1.1:	Open the bottle by pushing down firmly on the child-resistant cap and turning the cap to the left (counter-clockwise) (See Figure D). Do not throw away the child-resistant cap.
	Figure D
1.2:	If using a new dosing dispenser, remove the dosing dispenser from the wrapper (See Figure E). Throw away (dispose of) the wrapper in household trash. Figure E If using a used dosing dispenser, make sure the dosing dispenser has been cleaned (See Section C). If there is a cap on the dosing dispenser, remove it and throw away (dispose of) the cap into the household trash (See Figure F). Important: • Make sure you use the correct dosing dispenser size for your prescribed dose (See Table 1). • After 100 days, replace with a new dosing dispenser provided. A new replacement dosing dispenser may be used within the 100 days if necessary. • Check the dosing dispenser for any damage to the barrel, plunger or tip (See Figure G). If you cannot see the dosage marking or if it becomes hard to move the plunger, replace with a new dosing dispenser. Note: You can mark the prescribed dose on the dosing dispenser with a thin permanent marker to draw up the prescribed dose more easily.
	Figure F	Figure G
1.3: Push the plunger down fully to remove air from the dosing dispenser (See Figure H).
	Figure H
1.4:	Make sure the cap is removed from bottle and insert the tip of the dosing dispenser into the bottle. The tip of the dosing dispenser should fit securely into the hole of the bottle (See Figure I).
	Figure I
1.5:	Keep the dosing dispenser in place and turn the bottle upside down (See Figure J).
	Figure J
1.6:	Pull back the plunger slowly until the top of the plunger is even with the marking on the barrel of the dosing dispenser for your prescribed dose of LIVMARLI (See Figure K). See Figure L on how to align the plunger with your prescribed dose. Note: The medicine should appear colorless to light yellow and clear. If it is not, do not use the medicine and contact your pharmacist.
	Figure K	Figure L
	Note: Your dose may be different than the dose shown in the figures.
1.7:	Check the dosing dispenser for air bubbles. If you see any air bubbles, fully push the plunger so that the medicine flows back into the bottle and withdraw the prescribed dose (See Figure M).
	Figure M
1.8:	When you have measured the correct dose, leave the dosing dispenser in the bottle, and turn the bottle right side up (See Figure N).
	Figure N
1.9:	Carefully remove the dosing dispenser from the bottle by pulling straight up on the barrel of the dosing dispenser (See Figure O). Do not push the dosing dispenser plunger during this step.
	Figure O
Step 2: Give the dose
Note: LIVMARLI should be taken while sitting up or standing. After taking LIVMARLI wait a few minutes before lying down.
2.1:	Place the tip of the dosing dispenser against the inside of the cheek (See Figure P) and slowly push the plunger all the way in to give the entire dose of LIVMARLI (See Figure Q).
	Figure P	Figure Q
2.2:	Swallow the dose. If you are not sure the entire dose was swallowed, do not give another dose. Wait until the next scheduled dose.
2.3:	Place the child-resistant cap back on the bottle and turn the cap to the right (clockwise) (See Figure R).
	Figure R
	Section C: Cleaning instructions for the dosing dispenser
Step 1: Rinse dosing dispenser
1.1:	Fill a cup with water (See Figure S).
	Figure S
1.2:	Clean the dosing dispenser by pulling back on the plunger slowly to fill the dosing dispenser with water from the cup (See Figure T).
	Figure T
1.3:	Over a sink, push the water out of the dosing dispenser (See Figure U). Repeat several times to make sure that all of the LIVMARLI has been removed.
	Figure U
Step 2: Dry the dosing dispenser
2.1:	Remove the plunger from the barrel of the dosing dispenser by pulling the plunger and barrel away from each other (See Figure V).
	Figure V
2.2:	Shake off excess water (See Figure W).
	Figure W
2.3:	Place the plunger and barrel on a clean, dry paper towel to air dry. Store the dosing dispenser in a clean, dry place until your next dose (See Figure X).
	Figure X Before you give the next dose, put the dosing dispenser back together by pushing the plunger into the barrel (See Figure Y). Figure Y
	Section D: Disposal
• Throw away (dispose of) the bottle of LIVMARLI following the steps below 100 days after first opened or after the throw away (discard) date listed on the pharmacy label, even if there is still medicine in it. 1. Mix medicine with a substance such as dirt, cat litter, or used coffee grounds. 2. Place the mixture in a container such as a sealed plastic bag. 3. Delete all personal information on the prescription label of the empty medicine bottle, then throw away (dispose of) in the household trash or recycle the empty bottle. • Throw away (dispose of) used dosing dispensers in the household trash.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.			Revised: July 2024
LB00203 / LB00212

maralixibat

Product monograph

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