Other safety alerts
|
| |
| Singapore: Risk of hepatitis B virus reactivation with ibrutinib |
| |
The Health Sciences Authority (HSA) announces the potential risk of hepatitis B virus (HBV) reactivation associated with ibrutinib treatment. This risk was identified by the European Medicines Agency (EMA) following its review of overseas cases of HBV reactivation in patients who received treatment with ibrutinib.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) conducted a routine review examining the safety profile of ibrutinib, which identified cases of HBV reactivation in ibrutinib-treated patients. This cumulative review took into consideration available data from clinical trials, scientific literature, as well as postmarketing adverse drug reaction reports of HBV reactivation in patients receiving ibrutinib treatment. EMA’s review of cumulative data available till Nov 2016 identified eight cases of HBV reactivation in which the role of ibrutinib was considered possible or probable. In other cases, the role of ibrutinib in the onset of HBV reactivation could not be clearly established due to confounding by prior or concomitant treatment regimens known to be associated with the development of viral reactivation. The remaining cases had insufficient information to allow for meaningful causality assessment. None of the cases of HBV reactivation had led to fulminant liver failure requiring liver transplantation. However, there was one report with a fatal outcome, which was attributed to HBV reactivation and concurrent metastatic melanoma of the liver, lung and spleen.
Based on review of the available information, the EMA’s PRAC concluded in Jun 2017 that the benefit-risk balance of ibrutinib in relation to its approved indications remained unchanged. However, the PRAC recommended that healthcare professionals establish the HBV status of patients prior to initiating treatment with ibrutinib. In patients with positive hepatitis B serology, consultation with a hepatic disease expert is recommended before initiating treatment with ibrutinib. The PRAC also advised that patients with positive hepatitis B serology who require ibrutinib be monitored and managed according to local medical standards of care, so as to minimise the risk of HBV reactivation. The EU product information for ibrutinib would also be updated to include warnings on the risk of HBV reactivation and to include HBV reactivation as an uncommon adverse reaction.
To date, HSA has not received any local adverse reaction report of HBV reactivation in patients receiving treatment with ibrutinib. The Singapore package insert for ibrutinib (Imbruvica®) will be updated to include safety information regarding the risk of HBV reactivation. In view of the higher prevalence of hepatitis B in Singapore than in Europe, and the potentially serious outcomes caused by HBV reactivation in immunosuppressed patients, healthcare professionals should ensure that HBV status is established before initiating treatment with ibrutinib. They are also advised to closely monitor patients with positive hepatitis B serology who require ibrutinib and institute appropriate therapy as indicated to minimise the risk of hepatitis B reactivation.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/content/hsa/../risk-of-hepatitisbvirusreactivationwithibrutinib.html
In Hong Kong, there are 2 pharmaceutical products containing ibrutinib, namely Imbruvica Capsules 140mg (HK-64088) and Imbruvica Capsules 140mg (HK-65397). Both products are registered by Johnson & Johnson (Hong Kong) Ltd. (Johnson HK), and are prescription-only medicines. So far, the Department of Health (DH) has received 7 cases of adverse drug reaction related to ibrutinib, but these cases were not related to HBV reactivation.
Related news was previously issued by the UK Medicines and Healthcare products Regulatory Agency (MHRA), and was posted on the Drug Office website on 16 Aug 2017. Letters to inform local healthcare professionals of the risk of HBV reactivation of the drug were issued by the DH on the same day. In Dec 2017, the Registration Committee of the Pharmacy and Poisons Board discussed the matter and noted that Johnson HK had submitted application to update the package insert of the drug. This application has being reviewed and the updated package insert will include the safety information on the risk of HBV reactivation. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Thursday, Dec 28, 2017
Issued at HKT 15:00
|
| |
|
