The European Medicines Agency ("EMA") has published new recommended safety measures for the use of
Zydelig (idelalisib). The new measures were triggered by an
increased rate of serious adverse events, including deaths due
mostly to infections (see the previous Jones Day Update). EMA's Pharmacovigilance
Risk Assessment Committee ("PRAC") is issuing provisional
advice for doctors and patients using the cancer medicine Zydelig
to ensure that it continues to be used as safely as possible. Along
with other recommendations, PRAC recommends that all patients
treated with Zydelig receive antibiotics to prevent a particular
type of lung infection (Pneumocystisjirovecii
pneumonia).
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