Bendamustine

Red

Brand Name(s):Levact

Indication:Chronic lymphocytic leukaemia, multiple myeloma

Rationale:1,2,3

Considered:Apr-10

Review Date:Apr-26

Comments:
Drug safety update: Increased risk of non-melanoma skin cancer and PML.
It is advised that skin examinations should be periodically performed in patients on bendamustine-containing regimens and PML considered in the differential diagnosis for patients on bendamustine with new or worsening neurological, cognitive, or behavioural signs or symptoms.
MHRA March ’21

Drug safety alert:
Fatal toxicities mainly (opportunistic) infections, but some fatal cardiac, neurological, and respiratory toxicities were also reported.
March ’21

Drug Safety Update
Increased mortality observed in recent clinical studies in off-label use; monitor for opportunistic infections, hepatitis B reactivation
Jul-17
…………………………
Bendamustine is recommended as an option for
the first-line treatment of chronic lymphocytic
leukaemia (Binet stage B or C) in patients for
whom fludarabine combination chemotherapy is
not appropriate.

NICE Guidance Feb 2011