CHENODAL® (Chenodiol Tablets 250 mg)
CHENODAL® is an FDA-approved synthetic bile acid that was indicated in 1983 for patients with radiolucent stones in wellopacifying gallbladders, in whom selective surgery would be undertaken except for the presence of increased surgical risk due to systemic disease or age.1 Since then, advancements in care have significantly limited the use of CHENODAL® in these patients.
More recently, the FDA has cited that CHENODAL® is medically necessary for the treatment of cerebrotendinous xanthomatosis (CTX), a rare, progressive, and underdiagnosed genetic disorder affecting many parts of the body.2,3 In people with CTX, the body is unable to break down cholesterol properly, causing toxins (e.g., cholestaenol and bile alcohols) to build up throughout the body over time, which may lead to serious health issues.3,4 We are currently taking the necessary steps to have a CTX indication added to the full prescribing information for CHENODAL®, which has orphan drug designation from the FDA for the treatment of CTX.
While Retrophin does not market CHENODAL®, we distribute the medication to patients - as prescribed - through our Chenodal Total Care HUB®.
CHENODAL® is not an appropriate treatment for many patients with gallstones and should be reserved for carefully selected patients, and treatment must be accompanied by systematic monitoring of liver function.1
CHENODAL® is contraindicated in the presence of known hepatocyte dysfunction or bile ductal abnormalities such as intrahepatic cholestasis, primary biliary cirrhosis or sclerosing cholangitis (see Warnings); a gallbladder confirmed as nonvisualizing after two consecutive single doses of dye; radiopaque stones; or gallstone complications or compelling reasons for gallbladder surgery including unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary gastrointestinal fistula.1
CHENODAL® can cause serious side effects or potential complications, including liver damage (hepatoxicity) and serious hepatic disease, which could be fatal. Adverse reactions associated with CHENODAL® include increased cholecystectomy rate, dose-related diarrhea, increased serum total cholesterol and low-density lipoprotein, and decreases in white cell count.1 Please see full prescribing information for CHENODAL®.
Patients who are interested in treatment with CHENODAL® are encouraged to first consult a licensed healthcare professional. Additional information about CHENODAL® is available through our Chenodal Total Care HUB® (1-866-758-7068). This free support program dedicated to patients eases access to therapy, while providing live, on-demand support from dedicated pharmacists and HUB counselors to answer product questions, and assist with insurance verification, reimbursement options, and financial support.
We also offer co-pay assistance and free medication to patients who qualify, as part of our patient assistance program.
For medical inquiries and product complaints, contact Retrophin at 1-877-659-5518.
To report suspected adverse reactions,
at 1-877-659-5518 or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- CHENODAL® (Chenodiol Tablets 250 mg) [prescribing information]. San Diego, CA: Retrophin, Inc.; March 2015.
- Data on file. San Diego, CA: Retrophin, Inc.; July 2016.
- Lorincz, et al. Arch Neurol 2005;62(9):1459-1463.
- Gallus GN, et al. Neurol Sci. 2006;27:143-149.