Case reports suggest association between alectinib and rhabdomyolysis
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Case reports suggest association between alectinib and rhabdomyolysis Recent case reports support an association between alectinib and rhabdomyolysis, according to the latest WHO Pharmaceuticals Newsletter. As of 19 May 2019, there were eight reports for alectinib and the ADR rhabdomyolysis in VigiBase, the WHO global database of individual case safety reports. Alectinib is indicated as first-line monotherapy for adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer. In six reports, alectinib was the only suspected drug. In two reports, patients received concomitant medications for which rhabdomyolysis is a labelled event. A positive dechallenge was reported in six cases, with a positive rechallenge in two. The time to onset, when reported, was consistent, between 12 and 14 days. One case had a clear temporal sequence and rechallenge. The cases in VigiBase support an association between alectinib and rhabdomyolysis, suggests the Newsletter. Current product information includes myalgia and increased blood creatinine phosphokinase (CPK) levels for alectinib, but rhabdomyolysis is not described in the labels. There are also no warnings or precautions for healthcare professionals and patients regarding the potential of rhabdomyolysis as an adverse effect of alectinib in the product information. In a response, Roche comments that only one of the eight cases matches all three criteria for the diagnosis of rhabdomyolysis. However, in this case, alternative explanations for the event were present, and "a causal relationship between the rhabdomyolysis and alectinib is deemed to be not confirmed," suggests Roche. Roche also notes that myalgia and CPK elevation are "adequately reflected as adverse drug reaction in the alectinib product labels." WHO. Alectinib - Rhabdomyolysis. WHO Pharmaceuticals Newsletter : 4 Sep 2020. Available from: URL: https://www.who.int/publications/i/ item/9789240010741
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Reactions 19 Sep 2020 No. 1822
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