FDA Safety Communication for Ocaliva


FDA issues new communication about risk of liver injury with Ocaliva (obeticholic acid).

The FDA has issued a Drug Safety Communication about an increased risk of serious liver injury with incorrect dosages of Ocaliva (obeticholic acid). The drug is used to treat primary biliary cholangitis (PBC).

Obeticholic acid is being incorrectly dosed in some patients, which results in an increased risk of liver injury and death. The patients being misdosed are those with moderate to severe decreases in liver function who are receiving excessive doses of obeticholic acid, but the drug may be associated with liver injury in some patients with mild disease who are receiving the correct dose.

Health-care professionals, including pharmacists, are recommended to:

  • Determine the patient’s baseline liver function prior to starting obeticholic acid.

  • Patients with moderate to severe liver impairment (Child-Pugh B and C) should be started on the approved dosing schedule of 5 mg once weekly, rather than the 5 mg daily dosing used for other PBC patients. If needed, the dose can be increased up to a maximum approved dose of 10 mg twice weekly.

  • Health-care professionals should monitor patients frequently for disease progression, and reduce the dosing frequency to once or twice weekly for patients who progress to moderate or severe liver impairment.

  • In all patients treated with obeticholic acid, monitor frequently for liver injury (e.g., worsened liver blood tests and adverse liver-related reactions that may be inconsistent with the patient’s extent of disease). If liver injury is suspected, discontinue obeticholic acid. After the patient has stabilized, weigh the benefits against the risks when deciding whether to reinitiate treatment.

  • Educate patients on the symptoms of potential liver injury.
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