CTEXLI™ (chenodiol) tablets
CTEXLI is a bile acid indicated for the treatment of adults with cerebrotendinous xanthomatosis (CTX). Patients currently on CHENODAL®, which had a medical necessity for CTX, can view the full Prescribing Information here.
Important Safety Information
What are the possible side effects of CTEXLI?
Serious Side Effects—Hepatotoxicity (Liver Injury): You will need to undergo laboratory testing before starting and periodically while on treatment with CTEXLI to assess liver function. Changes in certain liver tests may occur during treatment and may be a sign of liver injury. People with preexisting liver disease or bile duct abnormalities may be at higher risk for liver injury during treatment. Stop taking CTEXLI immediately and tell your healthcare provider right away if you get any signs or symptoms of liver problems, including:
Most Common Side Effects: Diarrhea, headache, stomach pain, constipation, high blood pressure, muscular weakness, and upper respiratory tract infection..
Tell your healthcare provider about all the medications that you take, as CTEXLI may interact with other medicines. Do not take bile acid sequestering agents or aluminum-based antacids with CTEXLI. If you take coumarin, your doctor will need to monitor your prothrombin time (PT) while taking CTEXLI and may adjust your coumarin dose.
Your healthcare provider may temporarily or permanently stop treatment if you have certain side effects.
CTEXLI is taken by mouth three (3) times each day and can be taken with or without food. Swallow tablets whole.
These are not all the possible side effects of CTEXLI. For more information, ask your healthcare provider or pharmacist. Tell your doctor if you have any side effect that bothers you or that does not go away.
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Mirum Pharmaceuticals at 1-855-MRM-4YOU (1-855-676-4968).
Accessing CTEXLI in the U.S.
Connect with experts from the Mirum Access Plus program who can help secure access for patients and families.
