Maralixibat
Mechanism :
Maralixibat is an inhibitor of ileal bile acid transporter (IBAT).
IBAT inhibitors act locally in the distal ileum to reduce the reuptake of bile acids and increase the clearance of bile acids through the colon thus decreasing the serum concentration of bile acids.
Indication :
- Cholestatic Pruritis (in patients aged more than 1 year of age with Alagille syndrome)
Contraindications :
• Contraindicated in patients with hypersensitivity to drug components
• Use cautiously in patients with a history of hepatic decompensation
• Use cautiously in patients with fat-soluble vitamin deficiency
Pregnancy: Limited data available regarding use in the course of pregnancy. Caution advised. Monitor fat-soluble vitamin levels if administered.
Lactation: Limited data available regarding use in the course of breastfeeding. Caution advised. Monitor fat-soluble vitamin levels if administered.
Dosing :
Available as an oral solution of 9.5 mg/ml
Dosage for Cholestatic Pruritis (in patients aged more than 1 year of age with Alagille syndrome):
Days 1-7: 190 mcg/kg orally daily.
Day 8: Increase dose to 380 mcg/kg orally daily as tolerated; do not exceed 28.5 mg/day for patients with a weight of more than 70 kg.
Administer 30 minutes prior to the first meal of the day
Adverse Effect :
GI bleeding, fat soluble vitamin deficiency, diarrhea, abdominal pain, vomiting, elevation of AST and ALT, nausea, bone fractures.