FDA safety alert – New dosing for Ocaliva (obeticholic acid)
| Date: | February 9, 2018 |
| To: | Gastroenterologists |
| From: | HPSJ Pharmacy Department |
| Subject: | FDA safety alert – New dosing for Ocaliva (obeticholic acid) |
| Business: | Medi-Cal |
The Food and Drug Administration (FDA) is warning that the liver disease medicine Ocaliva (obeticholic acid) has been incorrectly dosed.
Previously, it was recommended daily in patients with moderate to severe Primary Biliary Cholangitis (PBC), a rare chronic liver disease.
Now, due to an increased risk of serious liver injury, the FDA has changed the dosing to weekly to prevent serious liver injury.
To ensure correct dosing and reduce the risk of liver problems, the FDA is clarifying the current recommendations for screening, dosing, monitoring and managing PBC patients with moderate-tosevere liver disease taking Ocaliva.
Health care professionals should follow the new Ocaliva dosing regimen in the new drug label, which is based on calculating a Child-Pugh score in PBC patients with suspected liver cirrhosis before treatment to determine their specific classification and starting dosage.
- Dosing higher than recommended in the drug label can increase the risk for liver decompensation, liver failure and sometimes death.
- Routinely monitor all patients for biochemical response, tolerability, and PBC progression, and re-evaluate Child-Pugh classification to determine if dosage adjustment is needed
- Close monitoring is recommended for patients at an increased risk of liver decompensation, including those with laboratory evidence of worsening liver function (e.g., total bilirubin, INR, albumin) or progression to cirrhosis.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online: www.fda.gov/MedWatch/report
- Call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
If you have questions, please contact our HPSJ Customer Service team (Monday-Friday 8 a.m. – 6 p.m. PST): 1-888-936-PLAN (7526), or TTY/TDD 711.