Inotuzumab ozogamicin (Besponsa) is an antibody-drug conjugate targeting CD22, indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia in adults and children aged 1 year and older. Although this drug has shown favorable efficacy in clinical practice, there are multiple serious risks associated with its use, particularly hepatotoxicity and myelosuppression.

Precautions for the Administration of Inotuzumab Ozogamicin (Besponsa)

Risk of Hepatotoxicity

Inotuzumab ozogamicin can cause severe and even fatal sinusoidal obstruction syndrome (SOS).

Risk factors include: Receiving hematopoietic stem cell transplantation.

Using a conditioning regimen containing double alkylating agents.

A history of liver disease or previous sinusoidal obstruction syndrome.

Advanced age, multiple salvage treatments, and a large number of treatment cycles.

Management recommendation: Discontinue the drug immediately if sinusoidal obstruction syndrome occurs.

Monitor liver function weekly during treatment and for at least one month after transplantation.

Increased Non-Relapse Mortality After Transplantation

Patients who receive hematopoietic stem cell transplantation after treatment with inotuzumab ozogamicin have a significantly increased non-relapse mortality rate; common causes of death are infection and sinusoidal obstruction syndrome.

Recommendations: Closely monitor for signs of infection and sinusoidal obstruction syndrome after transplantation.

Strictly control the number of treatment cycles: 2 cycles are recommended, and a 3rd cycle may be considered if necessary.

Myelosuppression

Inotuzumab ozogamicin can cause myelosuppression manifestations such as thrombocytopenia and neutropenia, and may even lead to infection or bleeding.

Monitoring and management: Check complete blood count before each administration.

Interrupt or adjust the dose if persistent cytopenia occurs.

Use anti-infective drugs and blood transfusion support if necessary.

Infusion-Related Reactions

Some patients may experience symptoms such as fever, chills, rash, and dyspnea during or after infusion.

Management measures: Closely monitor the patient for at least 1 hour.

Interrupt the infusion and provide symptomatic treatment if a reaction occurs.

Permanent drug discontinuation is required for severe cases.

QT Interval Prolongation

Inotuzumab ozogamicin may cause QT interval prolongation, increasing the risk of arrhythmia.

Recommendations: Conduct regular electrocardiogram (ECG) examinations and electrolyte tests before and during medication.

Avoid concurrent use of other drugs that can prolong the QT interval.

Monitoring During Inotuzumab Ozogamicin (Besponsa) Treatment

Liver Function Monitoring

Detect alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, and alkaline phosphatase before each administration.

Suspend medication if abnormalities occur, until liver function returns to normal.

Permanent drug discontinuation and active treatment are required for sinusoidal obstruction syndrome.

Complete Blood Count Monitoring

Check platelets, neutrophils, and other indicators before each administration.

Interrupt treatment if persistent low counts occur, until counts recover or are confirmed to be related to the underlying disease.

Cardiac Function Monitoring

Conduct baseline and regular electrocardiogram (ECG) examinations during medication.

Strengthen monitoring when combined with other drugs.