Ocaliva

Indicated For

Primary Biliary Cholangitis (PBC)

About This Medication

# Ocaliva Patient Assistance Program Guide: Important Update ## Critical Notice: Program Discontinuation As of November 14, 2025, Ocaliva (obeticholic acid) has been voluntarily withdrawn from the US commercial market by Intercept Pharmaceuticals. The Ocaliva Interconnect patient assistance program will no longer be available after December 31, 2025. If you are currently taking Ocaliva or were considering this medication, please contact your healthcare provider immediately to discuss alternative treatment options for primary biliary cholangitis (PBC). ## About Ocaliva (Obeticholic Acid) Ocaliva was a prescription medication used to treat primary biliary cholangitis (PBC), a chronic liver disease. It was indicated for adult patients with PBC either in combination with ursodeoxycholic acid (UDCA) for those with inadequate response to UDCA alone, or as monotherapy for patients unable to tolerate UDCA. The medication worked as a farnesoid X receptor (FXR) agonist, helping to reduce liver inflammation and slow disease progression. However, the FDA had previously restricted its use in patients with advanced cirrhosis due to serious safety concerns, including liver failure requiring transplant in some cases. ## Why Was Ocaliva Withdrawn? Intercept Pharmaceuticals announced the voluntary withdrawal on September 11, 2025, with the official market withdrawal effective November 14, 2025. This was not a medication recall. The company provided a transition period for patients to consult with healthcare providers about alternative treatment options. ## Previous Patient Assistance Program (Now Discontinued) The Ocaliva Interconnect support program previously offered assistance to eligible patients, including sample cards that could be redeemed at pharmacies for free medication supplies. However, this program is no longer available. **Final Support Contact:** For questions about your existing Ocaliva therapy through December 31, 2025, you could have called 1-844-622-4278. This number is no longer active as of January 1, 2026. ## What Should You Do Now? If you were taking Ocaliva or considering it as a treatment option: 1. **Contact Your Healthcare Provider:** Schedule an appointment to discuss alternative PBC treatments. Other FDA-approved therapies are available for PBC management. 2. **Review Your Current Medications:** If you have remaining Ocaliva supply, do not stop taking it without medical guidance. Your doctor will help you transition to an alternative medication. 3. **Explore Other Treatment Options:** Ask your healthcare provider about other approved PBC medications and whether patient assistance programs are available for those alternatives. 4. **Check Insurance Coverage:** If your doctor prescribes an alternative medication, verify coverage with your insurance plan, as prior authorization requirements may apply. ## Alternative PBC Treatments Several other FDA-approved medications are available for PBC treatment. Your healthcare provider can determine which option is most appropriate based on your individual health status, disease severity, and tolerance to medications. Some alternatives may also have patient assistance programs available through their manufacturers. ## Important Disclaimer This guide provides information about the discontinued Ocaliva patient assistance program. It is not medical advice. Always consult with your healthcare provider before making any changes to your medication regimen. If you have questions about PBC treatment options, contact your doctor or a hepatology specialist. For general information about PBC, you may contact the PBC Foundation at pbcfoundation.international.

Program information last verified: March 30, 2026