LIVMARLI- maralixibat chloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

maralixibat chloride (UNII: V78M04F0XC) (maralixibat - UNII:UYB6UOF69L)

Available from:

Mirum Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

LIVMARLI® is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 3 months of age and older. None. Risk Summary Maternal use at the recommended clinical dose of LIVMARLI is not expected to result in measurable fetal exposure because systemic absorption following oral administration is low [see Clinical Pharmacology (12.3)]. Maralixibat may inhibit the absorption of fat-soluble vitamins [see Warnings and Precautions (5.3) and Clinical Considerations] . In animal reproduction studies, no developmental effects were observed (see Data) . The estimated background risk of major birth defects for the indicated population is higher than the general population because Alagille syndrome is an autosomal dominant condition. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respec

Product summary:

Oral Solution LIVMARLI is a clear, colorless to yellow oral solution. Each amber plastic bottle contains LIVMARLI oral solution at a concentration of 9.5 mg per mL. One 30 mL amber plastic bottle: NDC 79378-110-01 Storage and Handling 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) [see Dosage and Administration (2.3)].

Authorization status:

New Drug Application

Summary of Product characteristics

LIVMARLI- MARALIXIBAT CHLORIDE SOLUTION
MIRUM PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LIVMARLI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LIVMARLI.
LIVMARLI (MARALIXIBAT) ORAL SOLUTION
INITIAL U.S. APPROVAL: 2021
RECENT MAJOR CHANGES
Indications and Usage (1)
3/2023
Dosage and Administration (2.1, 2.3)
3/2023
INDICATIONS AND USAGE
LIVMARLI is an ileal bile acid transporter (IBAT) inhibitor indicated
for the treatment of cholestatic pruritus
in patients with Alagille syndrome (ALGS) 3 months of age and older.
(1)
DOSAGE AND ADMINISTRATION
The recommended dosage is 380 mcg/kg once daily, taken 30 minutes
before a meal in the morning.
(2.1)
Starting dose is 190 mcg/kg orally once daily, and should be increased
to 380 mcg/kg once daily after
one week, as tolerated. (2.1)
DOSAGE FORMS AND STRENGTHS
Oral solution: 9.5 mg of maralixibat per mL. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Liver Test Abnormalities: Obtain baseline liver tests and monitor
during treatment. Dose reduction or
treatment interruption may be considered if abnormalities occur. For
persistent or recurrent liver test
abnormalities, consider LIVMARLI discontinuation. (5.1)
Gastrointestinal Adverse Reactions: Consider interrupting LIVMARLI
treatment if a patient experiences
persistent diarrhea, abdominal pain, vomiting, or has diarrhea with
bloody stool, vomiting, dehydration
requiring treatment, or fever. If diarrhea, abdominal pain, or
vomiting persists and no alternate etiology
is identified, consider stopping LIVMARLI treatment. (5.2)
Fat-Soluble Vitamin (FSV) Deficiency: Obtain baseline levels and
monitor during treatment. Supplement
if deficiency is observed. If FSV deficiency persists or worsens
despite FSV supplementation, consider
discontinuing LIVMARLI treatment. (5.3)
ADVERSE REACTIONS
Most common adverse reactions (≥5%) are diarrhea, abdominal pain,
vomiting, fat-soluble vitamin
deficiency, liver test abnormali