axicabtagene ciloleucel

Yescarta

tisagenlecleucel

Kymriah

NEW WARNING

The FDA has required prescribing information for B-cell maturation antigen (BCMA)-directed and CD19-directed genetically modified autologous chimeric antigen receptor T-cell immunotherapies to be revised to include a Boxed Warning related to the risk of T-cell malignancies. The warning states that T-cell malignancies have occurred after treatment with these immunotherapies and that serious outcomes, including hospitalization and death, have occurred.

Health care providers are directed to provide lifelong monitoring of patients for secondary malignancies, including T-cell malignancies, after treatment with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies. Patients should be advised of the risk for secondary malignancies and that lifelong monitoring is necessary.

Adverse effects from the use of BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.

Released: April 2024

Nursing Drug Handbook

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