Gemtuzumab (Mylotarg) is a CD33-targeted antibody-drug conjugate indicated for the treatment of newly diagnosed or relapsed/refractory CD33-positive acute myeloid leukemia.

Adverse Reactions of Gemtuzumab (Mylotarg)

Common Systemic Reactions (≥15%)

Bleeding-related: The incidence of bleeding of all grades reaches 90% (21% of which are grade 3-4).

Infection: Severe infections occur in 47% of patients.

Fever: Fever reactions occur in 69% of patients.

Gastrointestinal symptoms: Nausea (75%), vomiting (46%), constipation (37%), diarrhea (35%), mucositis (21%).

Liver function abnormalities: Increased AST (84%), increased ALT (90%), hypoalbuminemia (63%).

Other common reactions: Rash (16%), headache (25%), decreased appetite (37%), peripheral edema (28%).

Laboratory Abnormality Characteristics

Hematological toxicity: Anemia (96%), neutropenia (66%), thrombocytopenia (59%).

Metabolic disorders: Hypophosphatemia (64%), hypokalemia (57%), hyponatremia (44%).

Severe Adverse Reactions of Gemtuzumab (Mylotarg)

Hepatotoxicity and Hepatic Veno-Occlusive Disease (VOD)

VOD can be induced by monotherapy or combination chemotherapy, which can be fatal in severe cases.

High-risk factors: Moderate to severe baseline liver impairment, previous or subsequent hematopoietic stem cell transplantation, high-dose administration.

Monitoring requirements: Test liver function before each administration, and closely observe symptoms of VOD (hepatomegaly, ascites, rapid weight gain) after treatment.

Bleeding Risk

Fatal bleeding may occur due to persistent thrombocytopenia.

Management specifications: Monitor platelet counts frequently; severe bleeding requires treatment suspension or permanent discontinuation.

Infusion-Related Reactions

Clinical manifestations: Fever, chills, hypotension, tachycardia, hypoxia, respiratory failure.

Preventive measures: Glucocorticoids, antihistamines, and acetaminophen must be administered before each infusion.

QT Interval Prolongation

Similar to other calicheamicin-containing drugs, there is a risk of QTc prolongation.

Management requirements: For patients with risk factors, electrocardiogram and electrolyte monitoring should be performed before and during treatment.

Precautions for the Use of Gemtuzumab (Mylotarg)

Special Population Management

Pregnant women: Has a clear risk of fetal teratogenesis.

Lactating women: Breastfeeding is prohibited during treatment and within 1 month after the last dose.

Pediatric patients: Dosage needs to be adjusted according to body surface area.

Drug Preparation and Infusion

Must be prepared with sterile water, and the concentration should be controlled between 0.075-0.234mg/mL.

A light-shielding infusion bag and a 0.2-micron filter must be used during infusion.

The prepared drug must be used within 6 hours (including 2 hours of infusion time).