Bendamustine (Levact): increased mortality observed in recent clinical studies in off-label use; monitor for opportunistic infections, hepatitis B reactivation

Recent clinical trials have shown increased mortality when bendamustine (Levact) was used in combination treatments outside its approved indications. Be aware that the risk of opportunistic infections for all patients receiving bendamustine including those receiving off-label treatment may be greater than previously recognised. Be aware of your responsibilities if prescribing bendamustine outside the licensed indications.