For maximum clinical benefit, CHOLBAM® should be dosed by the patient’s weight1

The recommended dosage of CHOLBAM® (cholic acid) capsules is 10 to 15 mg/kg taken once per day, or in 2 divided doses, in pediatric and adult patients1

Number of CHOLBAM® capsules needed to achieve a recommended dosage

10 mg/kg/day dosage

Body weight (kg)Number of 50 mg capsulesNumber of 250 mg capsules
4 to 610
7 to 1020
11 to 1530
16 to 20*40

15 mg/kg/day dosage

Body weight (kg)Number of 50 mg capsulesNumber of 250 mg capsules
4 to 510
6 to 920
10 to 1330
14 to 1640
17 to 1901
20 to 23*11

*For additional weights, please see dosing charts in the Prescribing Information.

For patients with concomitant familial hypertriglyceridemia, the dosage is 11 to 17 mg/kg once daily or in 2 divided doses and is adjusted based on clinical response.

CHOLBAM® should be administered as follows1:

CHOLBAM® should be taken with food. For infants and children who cannot swallow capsules, CHOLBAM® capsules can be opened and mixed with breast milk or food.


CHOLBAM® should be administered in the lowest dose that effectively maintains liver function.

Administer the lowest dosage of CHOLBAM® that effectively maintains liver function1


Patients taking CHOLBAM® should be carefully monitored1

  • A continual supply of cholic acid, supplied by CHOLBAM®, may help to restore regulation of cholic acid.2
  • Monitor AST, ALT, serum GGT, ALP, bilirubin, and INR every month for the first 3 months, every 3 months for the next 9 months, every 6 months during the subsequent 3 years, and annually thereafter.1
  • Monitor more frequently during periods of rapid growth, concomitant disease, and pregnancy.1
  • Discontinue treatment with CHOLBAM® if liver function does not improve within 3 months of the start of treatment or if there are persistent indicators of worsening liver function.1
  • The utility of bile acid measurements in monitoring the clinical course of patients and in decisions regarding dose adjustment has not been demonstrated.1
Testing your patients for cholestasis and the presence of atypical bile acids may help diagnose BASD.

Learn about no-cost tests for your BASD patients

CHOLBAM® Total Care HUB - A comprehensive support program for you and your CHOLBAM® patients.

Get your BASD patients started on CHOLBAM®

REFERENCES:  1. CHOLBAM® (cholic acid) capsules, for oral use [prescribing information]. San Diego, CA: Travere Therapeutics, Inc.; April 2021.  2. Berendse K, Klouwer FCC, Koot BGP, et al. Cholic acid therapy in Zellweger spectrum disorders. J Inherit Metab Dis. 2016;39(6):859-868. doi: 10.1007/s10545-016-9962-9.  

INDICATION

CHOLBAM® (cholic acid) is a bile acid indicated for
  • Treatment of bile acid synthesis disorders due to single enzyme defects
  • Adjunctive treatment of peroxisomal disorders, including Zellweger spectrum disorders, in patients who exhibit manifestations of liver disease, steatorrhea, or complications from decreased fat-soluble vitamin absorption.

LIMITATIONS OF USE

The safety and effectiveness of CHOLBAM on extrahepatic manifestations of bile acid synthesis disorders due to single enzyme defects or peroxisomal disorders, including Zellweger spectrum disorders, have not been established.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS – Exacerbation of liver impairment

  • Monitor liver function and discontinue CHOLBAM in patients who develop worsening of liver function while on treatment.
  • Concurrent elevations of serum gamma glutamyltransferase (GGT) and alanine aminotransferase (ALT) may indicate CHOLBAM overdose.
  • Discontinue treatment with CHOLBAM at any time if there are clinical or laboratory indicators of worsening liver function or cholestasis.

ADVERSE REACTIONS

  • The most common adverse reactions (≥1%) are diarrhea, reflux esophagitis, malaise, jaundice, skin lesion, nausea, abdominal pain, intestinal polyp, urinary tract infection, and peripheral neuropathy.

DRUG INTERACTIONS

  • Inhibitors of Bile Acid Transporters: Avoid concomitant use of inhibitors of the bile salt efflux pump (BSEP) such as cyclosporine. Concomitant medications that inhibit canalicular membrane bile acid transporters such as the BSEP may exacerbate accumulation of conjugated bile salts in the liver and result in clinical symptoms. If concomitant use is deemed necessary, monitoring of serum transaminases and bilirubin is recommended.
  • Bile Acid Binding Resins: Bile acid binding resins such as cholestyramine, colestipol, or colesevelam adsorb and reduce bile acid absorption and may reduce the efficacy of CHOLBAM. Take CHOLBAM at least 1 hour before or 4 to 6 hours (or at as great an interval as possible) after a bile acid binding resin.
  • Aluminum-Based Antacids: Aluminum-based antacids have been shown to adsorb bile acids in vitro and can reduce the bioavailability of CHOLBAM. Take CHOLBAM at least 1 hour before or 4 to 6 hours (or at as great an interval as possible) after an aluminum-based antacid.

PREGNANCY

No studies in pregnant women or animal reproduction studies have been conducted with CHOLBAM. Women who become pregnant during CHOLBAM treatment are encouraged to call 1-844-202-6262.

LACTATION

Endogenous cholic acid is present in human milk. Clinical lactation studies have not been conducted to assess the presence of CHOLBAM in human milk, the effects of CHOLBAM on the breastfed infant, or the effects of CHOLBAM on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CHOLBAM and any potential adverse effects on the breastfed infant from CHOLBAM or from the underlying maternal condition.

GERIATRIC USE

It is not known if elderly patients respond differently from younger patients.

HEPATIC IMPAIRMENT

  • Discontinue treatment with CHOLBAM if liver function does not improve within 3 months of the start of treatment.
  • Discontinue treatment with CHOLBAM at any time if there are clinical or laboratory indicators of worsening liver function or cholestasis. Continue to monitor laboratory parameters of liver function and consider restarting at a lower dose when the parameters return to baseline.

OVERDOSAGE

Concurrent elevations of serum GGT and serum ALT may indicate CHOLBAM overdose. In the event of overdose, the patient should be monitored and treated symptomatically. Continue to monitor laboratory parameters of liver function and consider restarting at a lower dose when the parameters return to baseline.
To report SUSPECTED ADVERSE REACTIONS, contact Travere Therapeutics at 1‑877‑659‑5518 or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.
Please see accompanying full Prescribing Information for additional Important Safety Information.