Cholic Acid

Cholic acid is used to treat bile acid synthesis disorders and peroxisomal disorders.

Cholic acid is available under the following different brand names: Cholbam.

Dosages of Cholic Acid:

Adult and Pediatric Dosage Forms and Strengths

Capsule

• 50 mg
• 250 mg

Dosage Considerations – Should be Given as Follows:

Bile Acid Synthesis Disorders

• Indicated for bile acid synthesis disorders due to single enzyme defects (SEDs)
• Adults and children 3 weeks and older: 10-15 mg/kg/day orally once daily or divided twice daily
• Children under 3 weeks: Safety and efficacy not established

Peroxisomal Disorders

• Indicated for adjunctive treatment of peroxisomal disorders (PDs), including Zellweger spectrum disorders in patients who exhibit manifestations of liver disease, steatorrhea, or complications from decreased fat-soluble vitamin absorption
• Adults and children 3 weeks and older: 10-15 mg/kg/day orally once daily or divided twice daily
• Children under 3 weeks: Safety and efficacy not established

Dosage Modifications

Familial hypertriglyceridemia

• Patients with newly diagnosed or a family history of familial hypertriglyceridemia may have poor absorption of cholic acid from the intestine and require a 10% increase in the recommended dosage to account for losses due to malabsorption
• Recommended dosage range: 11-17 mg/kg/day orally once daily or divided twice daily
• Determine adequacy of the dosage regimen by monitoring clinical response, including steatorrhea, and laboratory values, including transaminases, bilirubin, and PT/INR laboratory values, including transaminases, bilirubin, and PT/INR

Dosing Considerations

• Safety and effectiveness on extrahepatic manifestations of bile acid synthesis disorders due to SEDs or PDs have not been established

Monitoring

• Monitor AST, ALT, GGT, alkaline phosphatase, 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 yr; and annually thereafter
• Monitor more frequently during periods of rapid growth, concomitant disease, or pregnancy
• Administer the lowest dose that effectively maintains liver function
• Discontinue treatment if the liver function does not improve within 3 months of the start of treatment or complete biliary obstruction develops
• Discontinue treatment at any time if there are persistent clinical or laboratory indicators of worsening liver function or cholestasis
• Concurrent elevations of GGT and ALT may indicate overdose; continue to monitor laboratory parameters of liver function and consider restarting at a lower dose when the parameters return to baseline
• Serum or urinary bile acid level using mass spectrometry is used in the diagnosis of bile acid synthesis disorders due to SEDs and PDs, including Zellweger spectrum disorders
• The utility of bile acid measurements in monitoring the clinical course of patients and in decisions regarding dose adjustment has not been demonstrated

Common side effects of Cholic Acid include:

• Diarrhea
• Reflux esophagitis
• Feeling unwell (malaise)
• Yellowing skin and eyes (jaundice)
• Skin lesions
• Nausea
• Abdominal pain
• Intestinal polyps
• Urinary tract infection (UTI)
• Numbness and tingling of extremities

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Cholic acid has no listed severe interactions with other drugs.
• Serious interactions of cholic acid include:
  • atazanavir
  • felodipine
• Cholic acid has moderate interactions with at least 35 different drugs.
• Cholic acid has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains cholic acid. Do not take Cholbam if you are allergic to cholic acid or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• None

Effects of Drug Abuse

• No information is available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Cholic Acid?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Cholic Acid?"

Cautions

• Monitor liver function and discontinue at any time there are clinical or laboratory indicators of worsening liver function or cholestasis
• Concurrent elevations of GGT and ALT may indicate overdose; discontinue
• Evidence of liver impairment was present before treatment with cholic acid in approximately 86% of patients with bile acid synthesis disorders due to SEDs and in approximately 50% of patients with PDs, including Zellweger spectrum disorders

Pregnancy and Lactation

• No studies of cholic acid use in pregnant women or animal reproduction studies have been conducted. There are limited published case reports discussing pregnancies in women taking cholic acid for 3beta-HSD deficiency, resulting in healthy infants.
• COCOA Registry (ChOlbam: Child and mOther's heAlth)
  • Women who become pregnant during treatment are encouraged to enroll
  • Patients or their healthcare providers should call 1-844-20C-OCOA or 1-844-202-6262
• Endogenous cholic acid is present in human milk. Clinical lactation studies have not been conducted to assess the presence of cholic acid in human milk, the effects on the breastfed infant, or the effects on milk production. There are no animal lactation data and no data from case reports available in the published literature on the use of cholic acid in breastfeeding women. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cholic acid and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition.