Other safety alerts
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| Canada: OCALIVA (obeticholic acid): New contraindication for the treatment of primary biliary cholangitis |
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Health Canada announces that OCALIVA (obeticholic acid) is now contraindicated for primary biliary cholangitis (PBC) patients with advanced disease, such as those with Child-Pugh Class B or C decompensated cirrhosis or a prior decompensation event, as well as for patients with compensated cirrhosis who have evidence of portal hypertension. This change is based on the frailty of and the inability to complete studies to verify its clinical benefits in these patients, as well as available safety data from post-marketing reports.
The independent data monitoring committee reviewed interim data from the studies designed to confirm efficacy and safety in PBC patients with decompensated cirrhosis (moderate to severe hepatic impairment [study 747-401]) and in a broader PBC population (study 747-302). The committee determined that the studies were highly unlikely to produce any useful results, and recommended the termination of Study 747-401 and that Study 747-302 stop enrolling subjects. In addition, there have been post-market reports of hepatobiliary disorders, including hepatic failure and hepatic cirrhosis, for which there is a possibility of a causal association with OCALIVA treatment in PBC patients with cirrhosis.
Given the difficulties completing the studies, the limited information available to further inform benefit/risk, the frailty of patients with PBC and decompensated cirrhosis, and available safety data from post-market reports, OCALIVA is now contraindicated for these patients, as well as for patients with compensated cirrhosis who have evidence of portal hypertension. The Canadian Product Monograph (CPM) for OCALIVA has been updated to include the new contraindication and additional warnings based on newly available safety data.
Information for healthcare professionals
- OCALIVA is now contraindicated in PBC patients with: decompensated cirrhosis (including Child-Pugh Class B or C) or a prior decompensation event; compensated cirrhosis who have evidence of portal hypertension.
- Do not start treatment with OCALIVA in patients who have decompensated cirrhosis (including Child-Pugh Class B or C) or who have had a prior decompensation event, or in patients who have compensated cirrhosis with evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia).
- Discontinue treatment with OCALIVA in PBC patients with decompensated cirrhosis, and in patients with compensated cirrhosis who have evidence of portal hypertension.
- Routinely monitor patients during OCALIVA treatment for progression of PBC. Treatment with OCALIVA should be permanently discontinued in patients with laboratory or clinical evidence of hepatic decompensation, including progression to Child-Pugh class B or C, or in patients who have compensated cirrhosis and develop evidence of portal hypertension.
Please refer to the following website in Health Canada for details:
http://recalls-rappels.canada.ca/en/alert-recall/ocaliva-obeticholic-acid-new-contraindication-treatment-primary-biliary-cholangitis
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by the United States Food and Drug Administration, and was posted on the Drug Office website on 27 May 2021.
Ends/Tuesday, Dec 6, 2022
Issued at HKT 15:00
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