CanadaYescarta (axicabtagene ciloleucel) Suspension for Intravenous Infusion used in patients with primary mediastinal B‑cell lymphoma (PMBCL) is the product of concern. Health Canada warns patients treated with Yescarta for PMBCL may be at increased risk of developing cerebral edema, including fatal events, compared with other large B‑cell lymphomas; cerebral edema is a known risk of CAR T‑cell therapy and is described in the Canadian product monograph. See Key Messages below.
How to identify it
Yescarta (axicabtagene ciloleucel) Suspension for Intravenous Infusion
The hazard
Patients being treated with Yescarta for primary mediastinal B-cell lymphoma (PMBCL) may be at increased risk for developing cerebral edema, including fatal events, compared to other large B-cell lymphomas. Cerebral edema is a known risk of CAR T-cell therapy and is described in the Yescarta Canadian product monograph (CPM).
What to do
See Key Messages below
Where it was sold
National
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)