cholic acid


koe-lik as-id

Trade Name(s)

  • Cholbam

Ther. Class.
orphan drugs

Pharm. Class.
bile acid replacements


  • Treatment of bile acid synthesis disorders caused by single enzyme defects (SEDs).
  • Adjunctive treatment of peroxisomal disorders (PDs) including Zellweger spectrum disorders associated with manifestations of liver disease, steatorrhea or complications from decreased fat-soluble vitamin absorption.


Cholic acid is the primary bile produced by the liver from cholesterol. Genetic deficiency of primary bile acids result in accumulation of intermediate bile acids and cholestasis. Bile acids facilitate fat digestion and absorption, facilitate absorption of fat-soluble vitamins, enhance bile flow and regulate feedback inhibition of bile acid synthesis. Deficiencies result in progressive hepatic damage.

Therapeutic Effect(s):

Stable/improved hepatic parameters, ↑ weight and improved survival.


Absorption: Absorbed by passive diffusion along the entire gastrointestinal tract. (absorption may be ↓ in newly diagnosed/family history of familial hypertriglyceridemia).

Distribution: Unknown.

Metabolism and Excretion: Enters into the bile acid pool, is conjugated in the liver and undergoes enterohepatic circulation and is actively secreted into bile, then released into the small intestine and enters another cycle of enterohepatic circulation. Some is reabsorbed in the colon, some is fecally eliminated.

Half-life: Unknown.




Contraindicated in:

  • None noted.

Use Cautiously in:

  • Worsening of liver function (discontinue/re-evaluate treatment)
  • Periods of rapid growth, concomitant disease, and pregnancy (careful/more frequent monitoring required with necessary dose adjustments).
  • OB:  enrollment in pregnancy surveillance program is recommended.
  • Lactation: Benefits of breastfeeding should be considered along with mother's need for treatment and potential adverse effects on the infant.
  • Pedi:  Safe and effective use in children ≥3 mos has been established.

Adverse Reactions/Side Effects

CNS: malaise

GI: abominal pain, diarrhea, intestinal polyps, exacerbation of liver impairment, nausea, reflux esophagitis

Derm: skin lesions

Neuro: peripheral neuropathy

* CAPITALS indicate life-threatening.
Underline indicate most frequent.



  •  Bile Salt Efflux Pump (BSEP) Inhibitors  including  cyclosporine  exacerbate liver impairment; avoid concurrent use, if unavoidable monitor liver function carefully•
  •  Bile acid resins  and  aluminum-based antacids  may ↓ absorption and effectiveness; administer cholic acid at least 1 hour before or at least 4 to 6 hours after.


PO (Adults and Children): 10–15 mg/kg once daily or in two divided doses; concomitant familial hypertriglyceridemid– 11–17 mg/kg once daily or in two divided doses. Use lowest dose that maintains liver function without further impairment; discontinue if there is no improvement in three mo or if deterioration occurs.


Capsules: 50 mg, 250 mg


  • Assess patient for signs and symptoms of worsening liver impairment periodically during therapy.

Lab Test Considerations:

Monitor AST, ALT, GGT, alkaline phosphatase, bilirubin and INR every mo for first 3 months, every 3 mo for next 9 months, every 6 mo during next three years and annually thereafter. Discontinue cholic acid if liver function does not improve within 3 mo of starting treatment, if complete biliary obstruction develops, or if persistent clinical or laboratory indicators of worsening liver function or cholestasis occur. Continue to monitor liver function and consider restarting a lower dose when parameters return to baseline.

Potential Diagnoses


  • PO Administer once or twice daily with food. Swallow capsules whole; do not crush or chew. If needed, capsules can be opened and contents mixed with food or drink (15–30 mL of infant formula, breast milk for younger children or mashed potatoes or apple puree for older children to mask taste). Stir for 30 seconds and administer immediately. Administer lowest dose that effectively maintains liver function.

Patient/Family Teaching

  • Instruct patient to take cholic acid as directed.
  • Advise patient to take cholic acid 1 hr before or 4–6 hrs after bile acid sequestrants or antacids containing aluminum.
  • Inform patient of need for liver function tests. Caution patient to notify health care professional if signs and symptoms of worsening liver impairment (skin or whites of eyes turn yellow, urine turns dark or brown [tea colored], pain on the right side of stomach, bleeding or bruising occurs more easily than normal, or increased lethargy) occur.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Encourage women who become pregnant during therapy to enroll in pregnancy registry (COCOA Registry (ChOlbam: Child and mOther's heAlth) by calling 1-844-20C-OCOA or 1-844-202-6262 to enroll.

Evaluation/Desired Outcomes

Stable/improved hepatic parameters, ↑ weight and improved survival.

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