Revised SPC: Kymriah (tisagenlecleucel) cells dispersion for infusion

SPC revised to advise that in management of cytokine release syndrome linked to Kymriah, the treatment centre should have access to additional doses of tocilizumab within 8 hours. Also if volume of Kymriah is ≤20mL, IV push may be used as an alternative method of administration.

SPS commentary:

The advice that patients should remain within proximity of a qualified clinical facility for at least 4 weeks following infusion has been clarified as within 2 hours of travel.


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