Besponsa
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Besponsa treats a type of cancer in the white blood cells called leukemia. Your provider may choose to give you medications before receiving Besponsa to reduce the chance of side effects.
Besponsa Overview
Besponsa is a prescription medication used to treat a type of leukemia called B-cell acute lymphoblastic leukemia (ALL) in adults.
Besponsa belongs to a group of drugs called monoclonal antibodies. These help by turning on the immune system to kill cancer cells.
This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.
Common side effects of Besponsa include a change in blood cell count, infection, and fatigue.
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Besponsa Drug Class
Besponsa is part of the drug class:
Besponsa FDA Warning
WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME AND INCREASED RISK OF POST-HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY
HEPATOTOXICITY, INCLUDING VOD
- Hepatotoxicity, including fatal and life-threatening VOD occurred in patients with relapsed or refractory acute lymphoblastic leukemia (ALL) who received Besponsa. The risk of VOD was greater in patients who underwent HSCT after Besponsa treatment; use of HSCT conditioning regimens containing 2 alkylating agents and last total bilirubin level ≥ upper limit of normal (ULN) before HSCT were significantly associated with an increased risk of VOD.
- Other risk factors for VOD in patients treated with Besponsa included ongoing or prior liver disease, prior HSCT, increased age, later salvage lines, and a greater number of Besponsa treatment cycles.
- Elevation of liver tests may require dosing interruption, dose reduction, or permanent discontinuation of Besponsa. Permanently discontinue treatment if VOD occurs. If severe VOD occurs, treat according to standard medical practice.
INCREASED RISK OF POST-HSCT NON-RELAPSE MORTALITY
- There was higher post-HSCT non-relapse mortality rate in patients receiving Besponsa, resulting in a higher Day 100 post-HSCT mortality rate.