US FDA approved new drug Besponsa that contains active pharmaceutical ingredient inotuzumab ozogamicin for the treatment of recurring acute lymphoblastic leukemia (ALL) in adult patients. Besponsa is targeted therapy for acute lymphoblastic leukemia and FDA categorized besponsa as breakthrough therapy.
Acute lymphoblastic leukemia is characterized by over proliferation abnormal and immature white blood cells. Leukocytes are also termed as white blood cells so, this disease is also known as white blood cells cancer. Prevalence rate of acute lymphoblastic leukemia remains high in childhood and old age especially after 50's. White blood cells are produce by bone marrow but due to abnormality in genetic makeup immature and abnormal white blood cells produce that inhibits production of normal leukocytes and spread to other organs of body.
Symptoms associated with acute lymphoblastic leukemia include limited or no production of normal leukocytes, fever, more susceptibility towards infections, chills, shortness of breath, chest pain, nausea, vomiting, headache and weakness. Unfortunately, these symptoms usually develop in late stages or when the disease progressed more than 50%. At the beginning of disease patient do not feel any significant symptom due to which it becomes difficult to identify it. Survival and prognosis is strongly depends upon stage at which it is identified.
Research is still in process to identify exact reason leukemia but many scientist believe that children who have family history of such events are more prone to this deadly disease due to vulnerability present in their genetic make-up. Besponsa contains Inotuzumab that is monoclonal antibody utilized to bind with CD22 and ozogamicin that is cytotoxic agent belongs to a class termed as calicheamicins.
Besponsa/inotuzumab Side effects
According to data provided by health authorities drug exhibit following side effects during clinical trials.
- Thrombocytopenia (Decrase in platelets)
- Leukopenia (Decrease in white blood cells)
- Body swelling
- Abdominal Discomfort
- Elevated level of liver enzymes
Besponsa/inotuzumab Uses/Prescribing information
US FDA approved besponsa for the treatment of refractory acute lymphoblastic leukemia in adults. US FDA categorized beponsa as a breakthrough therapy.
Besponsa is formulated as lyophilized powder for reconstitution in a single use vial. One vial of besponsa contains 0.9mg of drug. However, dosage frequency of besponsa is 0.8mg/m2 at first day of therapy then 0.5mg/m2 at 8th and 15th day. This is first cycle of drug administration in which
in total 1.8mg/m2 drug is administered in three divided doses. Similarly, in subsequent cycles total dose that is adminitered is 1.5mg/m2 in three divided doses.
This drug is administered by your healthcare practitioner (HCP), which usually means:
- It may comes under special items category.
- You cannot fill this prescription in a regular pharmacy. Your doctor, hospital, or clinic will provide this medication because of possible complications or other issues.
- This drug is likely to be covered under your medical benefit if you have insurance.