Inotuzumab ozogamicin (Besponsa) is an antibody-drug conjugate (ADC) targeting CD22, indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children aged 1 year and older.

What are the Side Effects of Inotuzumab ozogamicin (Besponsa)?

Hematologic Toxicity

Thrombocytopenia: Incidence of 51%, with 42% being Grade 3-4.

Neutropenia: Incidence of 49%, with 48% being Grade 3-4.

Febrile neutropenia: Incidence of 26%.

Anemia: Incidence of 36%, with 24% being Grade 3-4.

Systemic Reactions

Fever (32%).

Fatigue (35%).

Infection (48%, including 28% with severe infections).

Gastrointestinal Symptoms

Nausea (31%).

Vomiting (15%).

Abdominal pain (23%).

Diarrhea (17%).

Severe Side Effects of Inotuzumab ozogamicin (Besponsa)

Hepatotoxicity and Hepatic Veno-Occlusive Disease (VOD)

Overall incidence of VOD: 14%.

Among patients undergoing hematopoietic stem cell transplantation (HSCT), the incidence of VOD increases to 23%.

Risk factors include: Total bilirubin ≥ upper limit of normal (ULN) before stem cell transplantation, double alkylating agent conditioning regimen, prior liver disease, advanced age, multiple salvage therapies, etc.

Severe Infections and Bleeding

Incidence of fatal infections: 5%, including pneumonia, neutropenic sepsis, etc.

Incidence of severe bleeding: 5%, including intracranial hemorrhage, intra-abdominal hemorrhage, etc.

Precautions for Inotuzumab ozogamicin (Besponsa)

Monitoring Requirements During Treatment

Liver function: Monitor ALT, AST, total bilirubin, and alkaline phosphatase before each dose and after treatment.

Electrocardiogram (ECG): Monitor QTc interval at baseline and periodically during treatment.

Blood routine: Monitor complete blood count before each dose.

Precautions for Fertility and Lactation

Women of childbearing age: Effective contraception must be used during treatment and for 8 months after the last dose.

Male patients: Contraceptive measures should be taken during treatment and for 5 months after the last dose.

Lactation: Breastfeeding is prohibited during treatment and for 2 months after the last dose.

Patient Precautions

Prophylactic medication: Corticosteroids, antipyretic analgesics, and antihistamines must be administered before each dose to prevent infusion reactions.

Infusion management: The intravenous infusion time must be strictly controlled at 1 hour, with close monitoring during the infusion and for 1 hour after completion.