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Gemtuzumab is an antibody-drug conjugate (ADC) targeting the CD33 antigen, developed and produced by Pfizer of the United States.
1. Generic name : Gemtuzumabozogamicin
2. Trade name : MYLOTARG™
3. Dosage form : Lyophilized powder injection (4.5mg/bottle)
4. Main ingredients :Each bottle contains 4.5mg gemtuzumab, which is a CD33-targeting antibody-drug conjugate (ADC), containing a conjugate of anti-CD33 monoclonal antibody and cytotoxic calicheamicin.
1. Newly diagnosed CD33-positive acute myeloid leukemia (AML) : Applicable to adult patients.
2. Relapsed/refractory CD33-positive AML : Applicable to adults and children aged ≥2 years old.
1. Specifications of : 4.5mg/bottle (single-dose vial of lyophilized powder).
2. Characteristics of : The freeze-dried powder is a white to off-white block or powder. After reconstitution, it becomes a colorless to slightly yellow clear liquid.
1. Recommended dose of :
Newly diagnosed AML : 3mg/m² when combined with chemotherapy (days 1, 4, and 7).
Relapsed/refractory AML : single drug 3mg/m² (days 1, 4, and 7), with a maximum of 9mg/m² per treatment course.
2. Reconstitution method : Dissolve in 5 mL of sterile water for injection, shake gently until completely dissolved, then dilute in 0.9% sodium chloride injection (final concentration ≤ 0.3 mg/mL), and infuse in the dark.
3. Infusion time : Intravenous infusion within 2 hours, avoid mixing with other drugs.
1. Hepatotoxicity : Suspend administration when ALT/AST>2.5 times ULN or bilirubin>1.5 times ULN.
2. Myelosuppression : Delay administration when ANC<0.5×10⁹/L or platelets <50×10⁹/L.
1. Pretreatment : Corticosteroids, antihistamines, antipyretics and analgesics need to be given before infusion to prevent infusion reactions.
2. Risk of hepatic veno-occlusive disease (VOD) : Especially before and after hematopoietic stem cell transplantation, liver function needs to be monitored.
3. Bleeding risk : Monitor platelets, PT/aPTT and fibrinogen during treatment.
4. QT interval prolongation : Monitor the electrocardiogram regularly, especially when combined with other drugs that cause QT prolongation.
1. Pregnant women : Disabled (may cause fetal damage).
2. Lactation : Stop breastfeeding during treatment and within 1 month after the last dose.
3. Children : It is safe and effective for ≥2 years old, but there is insufficient data for <2 years old.
1. Common (≥20%) : Fever (85%), nausea (75%), infection (65%), thrombocytopenia (45%), VOD (14%).
2. Severe reactions : Sepsis (10%), acute respiratory distress syndrome (5%), fatal bleeding (3%).
It is prohibited for those allergic to gemtuzumab or calicheamicin.
1. Strong CYP3A inhibitor : It may increase the toxicity of calicheamicin and should be used with caution.
2. Antiplatelet/anticoagulant drug : increases the risk of bleeding, avoid combined use.
Store unopened vials in a refrigerator at 2-8°C and away from light. After reconstitution, use within 6 hours at room temperature or within 24 hours of refrigeration.
Manufacturer : Pfizer (Pfizer Inc., United States).
Note : During treatment, blood routine, liver function and heart function need to be monitored regularly. If VOD symptoms (ascites, hepatomegaly) or severe bleeding occur, the drug should be discontinued immediately.