What is Besponsa (inotuzumab ozogamicin) for?
Besponsa (inotuzumab ozogamicin) is a CD22-directed antibody-drug conjugate (ADC) used to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)1,2.
How does Besponsa (inotuzumab ozogamicin) work?
The active substance in Besponsa, inotuzumab ozogamicin, is a monoclonal antibody (a type of protein) that has been linked to a small molecule - N-acetyl-gamma-calicheamicin dimethylhydrazide - a cytotoxic agent that once activated provokes the death of cancer cells. The monoclonal antibody has been designed to recognise and attach to CD22 on the cancerous B cells. Once attached, the medicine is taken up by the cell where the cytotoxic agent becomes active, causing breaks in the cell’s DNA and thereby killing the cancer cell3.
Where has Besponsa (inotuzumab ozogamicin) been approved?
Besponsa (inotuzumab ozogamicin) was approved as a monotherapy for relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL)1,2 by:
European Medical Agency (EMA), European Union, June 29, 20173
Food and Drug Administration (FDA), USA, August 17, 20174
Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.
How is Besponsa (inotuzumab ozogamicin) taken?
The standard dosage is:
Prior to all infusions, patients need to be pre-medicated with a corticosteroid, antipyretic, and antihistamine1,2.
Besponsa (inotuzumab ozogamicin) is given as an infusion into a vein lasting for at least one hour. The infusions are given on days 1, 8 and 15 of a 3 or 4-week treatment cycle. The treatment may be interrupted or the dose may be reduced if the patient develops certain serious side effects3.
Patients in whom Besponsa (inotuzumab ozogamicin) works well should receive 2 or 3 cycles, after which they can have a stem cell transplant to replace their bone marrow, the only curative treatment. Patients whose treatment works well, but who are not going to receive a stem cell transplant, may receive up to a maximum of 6 cycles of treatment. In patients who do not respond to treatment, Besponsa (inotuzumab ozogamicin) should be stopped after 3 cycles3.
Complete information about Besponsa (inotuzumab ozogamicin) dosage and administration can be found in the resources section1,2.
Note: Consult your treating doctor for personalised dosing.
Are there any known adverse reactions or side effects of Besponsa (inotuzumab ozogamicin)?
Common adverse reactions
The most common adverse reactions (≥ 20%) listed in the prescribing information include1,2:
- Thrombocytopenia (low level of platelets)
- neutropenia (low level of neutrophils, a type of white blood cell)
- anemia (low levels of red blood cells)
- Leukopenia (low level of number of circulating neutrophil granulocytes)
- Pyrexia (fever)
- Nausea (feeling sick)
- febrile neutropenia (fever in concomitance with a level of neutrophils, a type of white blood cell)
- transaminases increased (liver damage)
- abdominal pain
- gamma-glutamyltransferase increased (high level of liver enzymes)
- hyperbilirubinemia (high levels of bilirubin, a substance made by the breakdown of red blood cells)
- Serious adverse reactions
The serious adverse reactions listed in the prescribing information include1,2:
febrile neutropenia (fever in concomitance with a level of neutrophils, a type of white blood cell)
heart rhythm disorder: QT interval prolongation
Use in specific populations
Besponsa (inotuzumab ozogamicin) can be fatal for a fetus, it is advised to avoid pregnancies and breast feeding1,2.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1,2.