LIVMARLI

Generic Name/API: maralixibat

Manufacturer: Mirum Pharmaceuticals, Inc.

Dosage Forms & Strength & Pack Size:
Oral solution: 9.5 mg of maralixibat per mL. 30ml per bottle

Storage:
Store unopened LIVMARLI between 20°C and 25°C (68°F and 77°F), excursion permitted
between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. After
opening the LIVMARLI bottle, store below 30°C (86°F).

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

Indication
LIVMARLI is a prescription medicine used to treat:

– cholestatic pruritus (itch) in patients who are 3 months of age and older with Alagille syndrome
– cholestatic pruritus (itch) in patients who are 5 years of age and older with progressive familial intrahepatic cholestasis (PFIC)
LIVMARLI is not for use in patients with PFIC type 2 who have a severe defect in the bile salt export pump (BSEP) protein
It is not known if LIVMARLI is safe and effective in children with Alagille syndrome who are under 3 months of age. It is not known if LIVMARLI is safe and effective in children with PFIC who are under 5 years of age. It is not known if LIVMARLI is safe and effective in adults who are 65 years of age and older.

Important Safety Information
What are the possible side effects of LIVMARLI?

– Liver injury. Changes in certain liver tests are common in patients with Alagille syndrome and PFIC but may worsen during treatment. These changes may be a sign of liver injury. In PFIC, this can be serious or may lead to transplant or death. Your health care provider should do blood tests and physical exams before starting and during treatment to check your liver function. Tell your health care provider right away if you get any signs or symptoms of liver problems, including:
nausea or vomiting
your skin or the white part of your eye turns yellow
dark or brown urine
pain on the right side of your stomach (abdomen)
fullness, bloating, or fluid in your stomach area (ascites)
loss of appetite
bleeding or bruising more easily than normal, including vomiting blood

-Stomach and intestinal (gastrointestinal) problems. LIVMARLI can cause stomach and intestinal problems, including diarrhea and stomach pain. Diarrhea can also cause the loss of too much body fluid (severe dehydration). Your health care provider may advise you to monitor for new or worsening stomach problems, including stomach pain, diarrhea, blood in your stool, or vomiting

Tell your health care provider right away if you have any new or worsening signs or symptoms of stomach and intestinal problems, including:
diarrhea
more frequent bowel movements than usual
stools that are black, tarry, or sticky, or have blood or mucous
severe stomach-area pain or tenderness
vomiting
urinating less often than usual
dizziness
headache
– A condition called Fat-Soluble Vitamin (FSV) Deficiency, caused by low levels of certain vitamins (vitamin A, D, E, and K) stored in body fat, is common in patients with Alagille syndrome and PFIC, but may worsen during treatment. Your health care provider should do blood tests before starting and during treatment, and may monitor for bone fractures and bleeding, which are common side effects
Tell your health care provider about all medicines that you take, as LIVMARLI may interact with other medicines. If you take a medicine that lowers cholesterol by binding bile acids, such as cholestyramine, colesevelam, or colestipol, take it at least 4 hours before or 4 hours after you take LIVMARLI.

Your health care provider may change your dose, or temporarily or permanently stop treatment if you have certain side effects.

In patients with Alagille syndrome, LIVMARLI is taken by mouth, 1 time each day, 30 minutes before a meal in the morning. In patients with PFIC, LIVMARLI is taken by mouth, 2 times each day, 30 minutes before a meal. Be sure to use the provided oral dosing dispenser to accurately measure the dose of medicine.

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