Maralixibat
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Tejasvi Aryaputra
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Overview
Maralixibat is an ileal bile acid transporter inhibitor that is FDA approved for the treatment of cholestatic pruritus associated with Alagille syndrome. Common adverse reactions include liver test abnormalities, abdominal pain,, fat-soluble vitamin deficiency, diarrhea, bone fractures, and gastrointestinal bleeding.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- 380 mcg/kg once daily, taken 30 minutes before the first meal of the day orally is recommended dosage in patients.
- 190 mcg/kg once daily is the recommended starting dosage for one week upon starting treatment of Maralixibat. After one week, increase dosage to recommended dosage of 380 mcg/kg.
- 3 mL per day is the maximum dosage in patients weighing above 70kg.
Table 1 shows Dosage of Maralixibat based on Patient’s Weight.
Insert Table 1
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Maralixibat in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Maralixibat in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Maralixibat FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Maralixibat in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Maralixibat in pediatric patients.
Contraindications
There are no contraindications associated with Maralixibat.
Warnings
Liver Test Abnormalities
- Trial studies show patients experiencing abnormal liver tests at the baseline.
- Comparing baseline liver test data in patients, liver tests worsened when taking Maralixibat.
- Patients showed increases in AST, ALT, or T/DB.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Maralixibat Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Maralixibat Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Maralixibat Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Maralixibat in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Maralixibat in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Maralixibat during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Maralixibat in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Maralixibat in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Maralixibat in geriatric settings.
Gender
There is no FDA guidance on the use of Maralixibat with respect to specific gender populations.
Race
There is no FDA guidance on the use of Maralixibat with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Maralixibat in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Maralixibat in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Maralixibat in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Maralixibat in patients who are immunocompromised.
Administration and Monitoring
Administration
- If a dosage is missed less than 12 hours of scheduled time, take dosage as soon as possible.
- If a dosage is missed by more than 12 hours, then skip dosage and take next dosage at scheduled time.
Monitoring
There is limited information regarding Maralixibat Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Maralixibat and IV administrations.
Overdosage
There is limited information regarding Maralixibat overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Maralixibat Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Maralixibat Mechanism of Action in the drug label.
Structure
There is limited information regarding Maralixibat Structure in the drug label.
Pharmacodynamics
There is limited information regarding Maralixibat Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Maralixibat Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Maralixibat Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Maralixibat Clinical Studies in the drug label.
How Supplied
There is limited information regarding Maralixibat How Supplied in the drug label.
Storage
There is limited information regarding Maralixibat Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Maralixibat |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Maralixibat |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Maralixibat Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Maralixibat interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Maralixibat Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Maralixibat Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.