Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
maralixibat chloride (UNII: V78M04F0XC) (maralixibat - UNII:UYB6UOF69L)
Mirum Pharmaceuticals Inc.
ORAL
PRESCRIPTION DRUG
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
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)].
New Drug Application
LIVMARLI- MARALIXIBAT CHLORIDE SOLUTION MIRUM PHARMACEUTICALS INC. ---------- 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 Prečítajte si celý dokument