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[Posted 05/26/2021]
Ocaliva (obeticholic acid) by Intercept Pharmaceuticals: Drug Safety Communication - Due to Risk of Serious Liver Injury, FDA Restricts Use of Ocaliva in Primary Biliary Cholangitis Patients with Advanced Cirrhosis
AUDIENCE: Patient, Health Professional, Pharmacy
ISSUE: The FDA is restricting the use of the liver disease medicine Ocaliva (obeticholic acid) in patients having primary biliary cholangitis (PBC) with advanced cirrhosis of the liver because it can cause serious harm. Some PBC patients with cirrhosis who took Ocaliva, especially those with evidence of advanced cirrhosis, developed liver failure, sometimes requiring liver transplant. In the five years since Ocaliva's accelerated approval, FDA identified 25 cases of serious liver injury leading to liver decompensation or liver failure associated with Ocaliva in PBC patients with cirrhosis, both in those without clinical signs of cirrhosis (compensated) or in those with clinical signs of cirrhosis (decompensated). Many of these PBC patients had advanced cirrhosis before starting Ocaliva.
FDA added a new Contraindication, FDA's strongest warning, to the Ocaliva prescribing information and patient Medication Guide stating that Ocaliva should not be used in PBC patients with advanced cirrhosis. FDA also revised the Boxed Warning, our most prominent warning, to include this information along with related warnings about this risk.
Based on the original clinical trials, FDA believes the benefits of Ocaliva outweigh the risks for PBC patients who do not have advanced cirrhosis. FDA will continue to monitor and evaluate the clinical benefit and adverse events of Ocaliva and will communicate any new information to the public if it becomes available.
BACKGROUND: PBC is a rare, chronic disease affecting the ducts in the liver that carry bile, which helps with digestion.
RECOMMENDATIONS:
Patients:
• Patients with PBC who have cirrhosis and are taking Ocaliva should talk to your health care professional about these new warnings. Contact your prescriber immediately if you develop any symptoms, which may be signs of worsening liver injury or development of advanced cirrhosis.
Health Care Professionals:
• Health care professionals should determine before starting Ocaliva whether a patient with PBC has advanced cirrhosis as the medicine is contraindicated in these patients. Advanced cirrhosis is defined as cirrhosis with current or prior evidence of hepatic decompensation (e.g., encephalopathy, coagulopathy) or portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia).
• Routinely monitor patients during Ocaliva treatment for progression of PBC with laboratory and clinical assessments to determine whether the medicine needs to be discontinued. Permanently discontinue Ocaliva in patients with cirrhosis who progress to advanced cirrhosis.
• Also monitor patients for clinically significant liver-related adverse reactions that may manifest as development of acute-on-chronic liver disease with nausea, vomiting, diarrhea, jaundice, scleral icterus, and/or dark urine. Permanently discontinue Ocaliva in patients developing these symptoms.
Read more about the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at: https://reurl.cc/3amL10
美國FDA 發布藥物安全警訊，患有晚期肝硬化的原發性膽管性膽管炎（primary biliary cholangitis, PBC）的病人須限制使用肝臟疾病藥物Ocaliva（obeticholic acid），因為可能引起嚴重的傷害。某些服用Ocaliva的PBC肝硬化患者，特別是晚期肝硬化者，造成肝功能衰竭，有些甚至需進行肝移植。自Ocaliva加速核准以來的五年，美國FDA發現25例嚴重肝損傷導致肝失代償或肝功能衰竭的案例，與患有肝硬化（包括無肝硬化臨床症狀（代償型）或有臨床肝硬化症狀的患者（失代償））的PBC患者服用Ocaliva相關。這些PBC患者中有許多在開始服用Ocaliva前已患有晚期肝硬化。
美國FDA於Ocaliva仿單和病人用藥指南中增加新的禁忌症，申明Ocaliva不應用於晚期肝硬化的PBC患者。美國FDA另修訂加框警語，納入此風險之訊息。
PBC是一種罕見且影響肝臟中輸送膽汁的膽道的慢性疾病。根據原始的臨床試驗，美國FDA認為使用Ocaliva於未患有晚期肝硬化之PBC患者的益處仍大於其風險。美國FDA將繼續監測和評估Ocaliva的臨床益處和不良事件，如有任何最新消息將隨時告知大眾。
建議：
病人
● 患有肝硬化並正在服用Ocaliva的PBC患者，應就這些新警訊與醫療專業人員討論。若出現任何症狀，請立即與醫師聯繫，因這些症狀可能是肝損傷惡化或晚期肝硬化發展的跡象。
醫療專業人員
● 因晚期肝硬化之PBC患者禁用此藥，故醫療專業人員應在開立Ocaliva前確定PBC患者是否為晚期肝硬化。晚期肝硬化的定義為目前或先前具有肝失代償（例如肝性腦病變、凝血問題）或肝門靜脈高壓（例如腹水、胃食道靜脈曲張、持續性血小板減少低下）的證據之肝硬化。
● 在Ocaliva治療期間，定期藉由實驗室數值和臨床評估監測患者的PBC進程，以決定是否需停藥。進展為晚期肝硬化的患者應永久停用Ocaliva。
● 監測患者臨床上與肝臟相關的顯著不良反應，這些不良反應可能表現為慢性肝病的急性發作合併噁心、嘔吐、腹瀉、黃疸、鞏膜呈現黃色和/或深色尿液。出現這些症狀的患者應永久停用Ocaliva。
更多相關訊息與連結請參考FDA網址：https://reurl.cc/3amL10
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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