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Review

Isatuximab: Short Chapter

No authors listed
In: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012.
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Review

Isatuximab: Short Chapter

No authors listed.
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Excerpt

Isatuximab is a cytolytic monoclonal antibody to CD38 used in the therapy of multiple myeloma in combination with pomalidomide and dexamethasone. The addition of isatuximab to pomalidomide and dexamethasone increases the rate of severe infections and serious adverse events associated with pomalidomide and dexamethasone alone, but does not increase the rate of serum ALT, AST or bilirubin elevations. Since its more widespread clinical use, isatuximab has not been implicated in cases clinically apparent liver injury.

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References

    1. FDA. Integrated Review. 2020.
    1. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761113Orig1s000M... [ (FDA Integrated review of the data on isatuximab safety and efficacy submitted in support of the application for approval as therapy of multiple myeloma mentions that ALT elevations arose in 36% [4% above 5 times ULN] of patients receiving isatuximab vs 31% [3% above 5 times ULN] with pomalidomide and dexamethasone alone, and there were no serious or fatal liver related adverse events attributable to therapy with isatuximab). ]
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