CHENODIOL

Other

Brand names: CTEXLI

Oral

Mechanism of Action

12.1 Mechanism of Action Endogenous chenodiol (chenodeoxycholic acid) is a primary bile acid, synthesized from cholesterol in the liver. In CTX, the major bile acid synthesis pathways are disrupted due to partial or total deficiency in sterol 27-hydroxylase encoded by the CYP27A1 gene. CTEXLI may act to replace deficient levels of the endogenous bile acid chenodeoxycholic acid in patients with CTX. Increased chenodiol levels in the enterohepatic bile acid pool restore the activation of farnesoid X receptor (FXR) and downregulate CYP7A1 leading to suppression and reduction of atypical bile acids and bile alcohols including cholestanol and 23S-pentol.

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS None. None. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Hepatotoxicity : Obtain baseline liver transaminase and total bilirubin levels in all patients and monitor yearly and as clinically indicated
Patients with pre-existing liver disease or bile duct abnormalities may be at higher risk for hepatotoxicity during treatment with CTEXLI

Known Side Effects

8 documented side effects by frequency

Diarrhea

>10%

Vomiting

>10%

Constipation

1-10%

Drug Not Working

1-10%

Nausea

0.1-1%

Headache

0.1-1%

Decreased Appetite

0.1-1%

Dizziness

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral