Inotuzumab ozogamicin (Besponsa) is a targeted drug used for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia. Although it has shown favorable efficacy in clinical practice, patients must fully understand its potential side effects.
What Are the Side Effects of Inotuzumab Ozogamicin (Besponsa)?
Hematological System-Related Side Effects
Thrombocytopenia: The incidence rate is as high as 51%, and severe cases may increase the risk of bleeding.
Neutropenia: Occurs in approximately 49% of patients, which easily leads to infections.
Anemia: Occurs in approximately 36% of patients, presenting with symptoms such as fatigue and shortness of breath.
Febrile neutropenia: Occurs in approximately 26% of patients and requires close monitoring.
Systemic Reactions
Fever: Occurs in approximately 32% of patients.
Fatigue: Occurs in approximately 35% of patients, and severe cases may affect daily life.
Headache: Occurs in approximately 28% of patients.
Gastrointestinal Reactions
Nausea and vomiting: The incidence rates are approximately 31% and 15%, respectively.
Abdominal pain: Occurs in approximately 23% of patients.
Elevated liver enzymes: Such as transaminases and gamma-glutamyl transferase, indicating liver function impairment.
Other Common Reactions
Infection: Occurs in approximately 48% of patients, and some are severe infections.
Bleeding: Occurs in approximately 33% of patients, ranging from mild nosebleeds to severe internal bleeding.
Severe Side Effects of Inotuzumab Ozogamicin (Besponsa) That Require Vigilance
Hepatotoxicity
Including Hepatic Venous Occlusive Disease (VOD).
Occurrence: Approximately 14% of patients receiving inotuzumab ozogamicin treatment develop VOD, and some cases are fatal.
High-risk factors: A history of liver disease, previous hematopoietic stem cell transplantation, older age, multiple rounds of treatment, etc.
Warning symptoms: Jaundice, pain in the liver area, rapid weight gain, ascites, etc.
Management recommendations: Once VOD is diagnosed, the drug should be discontinued immediately and supportive treatment should be initiated.
Increased Non-Relapse Mortality After Hematopoietic Stem Cell Transplantation
Main causes: VOD and infection are the main causes of death.
Recommendation: Strengthen infection prevention and liver function monitoring before and after transplantation.
Myelosuppression
Manifestations: Severe decrease in platelets and neutrophils, which can lead to infection and bleeding.
Severe consequences: Some patients experience fatal infections or bleeding events.
Management: Monitor blood routine regularly; suspend or adjust the dose if necessary.
Infusion-Related Reactions
Manifestations: Fever, chills, rash, dyspnea, etc.
Time of occurrence: Mostly occur after the first infusion.
Management: Use glucocorticoids, antihistamines, and antipyretics for prevention before infusion; immediately interrupt the infusion and provide treatment if a reaction occurs.
Precautions for the Administration of Inotuzumab Ozogamicin (Besponsa)
Preparation Before Medication
Confirm CD22 positivity: Only applicable to patients with CD22-positive B-cell precursor ALL.
Pretreatment medication: Glucocorticoids, antipyretics, and antihistamines must be used before each infusion.
Cytoreduction: If the peripheral blood blast count is high, cytoreductive therapy should be performed first.
Dose Adjustment and Monitoring
Liver function monitoring: Check indicators such as ALT, AST, and total bilirubin before each administration.
Blood routine monitoring: Check indicators such as platelets and neutrophils before each treatment cycle.
Dose adjustment: Adjust the dose according to the severity of adverse reactions; suspend or discontinue treatment if necessary.
Patient Education and Follow-Up
Symptom reporting: Patients should be aware of warning signs such as VOD, infection, bleeding, and cardiac symptoms, and report them in a timely manner.
Regular reexamination: Regularly reexamine blood routine, liver function, and electrocardiogram during and after treatment.
