Produktresumé för våra godkända läkemedel på FASS:
Breyanzi® (lisokabtagen-maraleucel) | Inrebic® (fedratinib) | Reblozyl® (luspatercept) | Revlimid® (lenalidomid)
Nov 2025
The European Medicines Agency (EMA) has approved a label update for Breyanzi, reducing the requirements for post-infusion monitoring of patients who are treated with Breyanzi in aggressive B-cell lymphoma. The changes include the following guidance, but should also be made at the treating physicians discretion.
Patients should be monitored 2–3 times during the first week following infusion for signs and symptom sof potential CRS, neurologic events, and other toxicities. Physicians should consider hospitalisation at the first signs or symptoms of CRS and/or neurologic events.
The frequency of monitoring after the first week should be carried out at the physician’s discretion and continued for at least 2 weeks after infusion – reduced from 4 weeks previously.
Patients should be instructed to remain within proximity of a qualified treatment centre for at least 2 weeks following infusion – reduced from 4 weeks previously.
Due to the potential for neurologic events, including altered mental status or seizures, patients receiving Breyanzi should refrain from driving or operating heavy or potentially dangerous machinery for at least 4 weeks after infusion – reduced from 8 weeks previously.
References
1. Breyanzi product resumé, www.fass.se
2009-SE-2500020 13 nov 2025
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