Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
Cholbam Generic Name & Formulations
Legal Class
Rx
General Description
Cholic acid 50mg, 250mg; caps.
Pharmacological Class
Bile acid.
How Supplied
Caps—90
Manufacturer
Generic Availability
NO
Cholbam Indications
Indications
Bile acid synthesis due to single enzyme defects (SEDs). Adjunct in peroxisomal disorders (PDs) including Zellweger spectrum disorders in patients who exhibit manifestations of liver disease, steatorrhea or complications from decreased fat soluble vitamin absorption.
Limitations of Use
Safety and efficacy on extrahepatic manifestations of bile acid synthesis disorders due to SEDs or PDs not established.
Cholbam Dosage and Administration
Adults and Children
<3wks: not established. Take with food. Swallow whole. If unable to swallow caps, can open and mix contents with infant formula/breast milk or soft foods. ≥3wks: 10–15mg/kg once daily or in 2 divided doses. Concomitant familial hypertriglyceridemia: 11–17mg/kg once daily or in 2 divided doses.
Cholbam Contraindications
Not Applicable
Cholbam Boxed Warnings
Not Applicable
Cholbam Warnings/Precautions
Warnings/Precautions
Exacerbation of hepatic impairment. Discontinue if liver function does not improve within 3 months of treatment initiation, complete biliary obstruction develops, or if persistent clinical or lab indicators of worsening liver function or cholestasis present; monitor and consider restarting at lower dose after return to baseline. Monitor AST, ALT, GGT, ALP, bilirubin, INR monthly for the first 3 months, every 3 months for the next 9 months, every 6 months for the next 3 years, and yearly thereafter; more frequently during rapid growth, concomitant disease, pregnancy. Use lowest effective dose that maintains liver function. Elderly. Pregnancy. Nursing mothers.
Cholbam Pharmacokinetics
See Literature
Cholbam Interactions
Interactions
Avoid concomitant bile salt efflux pump inhibitors (eg, cyclosporine); if concomitant use needed, monitor serum transaminases and bilirubin. Antagonized by bile acid binding resins (eg, cholestyramine, colestipol, colesevelam) or aluminum-based antacids. Separate cholic acid dosing by ≥1hr before or 4–6hrs after bile acid resins or aluminum-based antacids.
Cholbam Adverse Reactions
Adverse Reactions
Diarrhea, reflux esophagitis, malaise, jaundice, skin lesion, nausea, abdominal pain, intestinal polyp, UTI, peripheral neuropathy.
Cholbam Clinical Trials
See Literature
Cholbam Note
Not Applicable
Cholbam Patient Counseling
See Literature
