Other safety alerts
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| Canada: Association of RITUXAN® (rituximab) with Toxic Epidermal Necrolysis (TEN) and Stevens-Johnson Syndrome (SJS) |
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Hoffmann-La Roche Limited (Roche), in consultation with Health Canada, informed healthcare professionals and the public of important new safety information associated with RITUXAN. RITUXAN is a recombinant chimeric anti-CD20 monoclonal antibody indicated for use in Canada in the treatment of Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Rheumatoid Arthritis (RA), and Granulomatosis with Polyangiitis (GPA, also known as Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA). Cases of Toxic Epidermal Necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), have been very rarely reported in the post-marketing setting, in patients who have used RITUXAN for the treatment of haematological malignancies and autoimmune disorders. Some of the cases of Toxic Epidermal Necrolysis (TEN) and Stevens-Johnson Syndrome (SJS) have been fatal. Health Canada advised healthcare professionals that in case of the occurrence of severe skin reactions, RITUXAN treatment should be discontinued; and the decision to re-administer RITUXAN must be carefully assessed based on the individual patient’s benefit–risk profile.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../23231a-eng.php
In Hong Kong, rituximab is registered under the brand name MabThera. And there are four MabThera products, namely MabThera Inj 500mg/50ml (HK-46231), MabThera Inj 100mg/10ml (HK-46232), MabThera Concentrate for Solution for Infusion 100mg/10ml (Germany) (HK-59248) and MabThera Concentrate for Solution for Infusion 500mg/50ml (Germany) (HK-59249), registered by Roche Hong Kong Limited and they are prescription-only medicines. Related news has been released by Health Sciences Authority (HSA) and was posted on the website of Drug Office on 9 February 2013. Letter to inform healthcare professionals to draw their attention on the issue and urge them to report any adverse drug reaction related to the drug was issued on 14 February 2013. The Department of Health will keep vigilant on any safety updates of the drug and actions taken by other overseas regulatory authorities for consideration of any action deemed necessary.
Ends/ Tuesday, February 26, 2013
Issued at HKT 12:00
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