While Mechanism And Frequency Currently Unknown, This Situation Can Involve Acute Hepatic Failure Or Fulminant Hepatitis Leading To Liver Transplantation Or Death
(Posted by Tom Lamb at DrugInjuryWatch.com)
Back in May 2016 Health Canada issued a safety warning, "BCR-ABL Tyrosine Kinase Inhibitors [GLEEVEC (imatinib mesylate), TASIGNA (nilotinib), BOSULIF (bosutinib), SPRYCEL (dasatinib), ICLUSIG (ponatinib hydrochloride)] - Risk of Hepatitis B Reactivation", which did not receive much public attention in the US.
According to this May 4, 2016 Health Canada document, BCR-ABL tyrosine kinase inhibitors (TKIs) are used for the treatment of specific types of blood cancers, including Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) and Ph+ acute lymphoblastic leukemia (ALL), and less commonly, other types of cancers.
The currently available medicines in this BCR-ABL TKIs class of drugs include:
- Gleevec (imatinib mesylate) -- Novartis Pharmaceuticals Canada Inc.
- Tasigna (nilotinib) -- Novartis Pharmaceuticals Canada Inc.
- Bosulif (bosutinib) -- Pfizer Canada Inc.
- Sprycel (dasatinib) -- Bristol-Myers Squibb Canada
- Iclusig (ponatinib hydrochloride) -- ARIAD Pharmaceuticals, Inc.
Further, according to Health Canada, this apparent side effect of HBV reactivation in chronic HBV carriers is considered to be a class-effect of BCR-ABL TKIs.
Gleevec / Iclusig
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From that May 2016 Health Canada document, we get the following detailed safety information about these drugs:
A recent review of clinical trials and reports received in the post-marketing period as well as published medical literature indicate that cases of HBV reactivation have occurred in patients who are carriers for the virus after receiving BCR-ABL TKIs. In some of the cases, HBV reactivation caused acute liver failure or fulminant hepatitis requiring liver transplantation or death. HBV reactivation occurred at different points during therapy, with cases reported worldwide between three weeks and more than 8 years after starting treatment.
Although no mechanism for HBV reactivation has been identified to date, based on a review of the available evidence, HBV reactivation is considered to be a class effect of BCR-ABL TKIs.
This document goes on to note that the Canadian Product Monographs for all BCR-ABL TKIs drugs will be updated to reflect this new safety information concerning hepatitis B reactivation.
For patients, it is important to know the symptoms of hepatitis include weight loss, fever, abdominal pain, and nausea or vomiting followed by yellowing of the skin (jaundice).
We will continue to monitor this still relatively new safety development for Gleevec and Islusig, as well as Tasigna, Bosulif, and Sprycel. In particular, we will watch for developments regarding (1) the mechanism and (2) the frequency of HBV reactivation during treatment, both of which Health Canada says are not known at present.
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