Jitumumab is an antibody drug conjugate (ADC) targeting CD33 antigen, developed and produced by Pfizer in the United States.

1、 Drug name and main ingredients

1. Common name: Gemtuzumab bozogamicin

2. Product Name: MYLOTARG ™

3. Dosage form: Freeze dried powder injection (4.5mg/bottle)

4. Main ingredients: Each bottle contains 4.5mg of cetuximab, which is a CD33 targeted antibody drug conjugate (ADC). It contains a conjugate of anti-CD33 monoclonal antibody and the cytotoxic kanamycin.

2、 Indications

1. Newly diagnosed CD33 positive acute myeloid leukemia (AML): suitable for adult patients.

2. Recurrent/refractory CD33 positive AML: suitable for adult and children aged ≥ 2 years.

3、 Specifications and characteristics

1. Specification: 4.5mg/bottle (single dose penicillin bottle freeze-dried powder).

2. Appearance: Freeze dried powder is a white to off white block or powder, and after reconstitution, it becomes a colorless to slightly yellow clear liquid.

4、 Usage and dosage

1. Recommended dosage:

Newly diagnosed AML: 3mg/m ² during combination chemotherapy on days 1, 4, and 7.

Recurrent/refractory AML: monotherapy at 3mg/m ² (on days 1, 4, and 7), with a maximum of 9mg/m ² per course of treatment.

2. Dissolving method: Dissolve 5mL of sterile injection water, shake gently until completely dissolved, then dilute in 0.9% sodium chloride injection (final concentration ≤ 0.3mg/mL) and transfuse in the dark.

3. Infusion time: 2 hours intravenous infusion, avoid mixing with other drugs.

5、 Dose adjustment

1. Hepatotoxicity: Discontinue administration when ALT/AST>2.5 times ULN or bilirubin>1.5 times ULN.

2. Bone marrow suppression: Delayed administration when ANC<0.5 × 10 ⁹/L or platelet<50 × 10 ⁹/L.

6、 Medication precautions

1. Preparation: Corticosteroids, antihistamines, and antipyretic analgesics should be administered before infusion to prevent infusion reactions.

2. Risk of hepatic vein occlusion (VOD): Liver function needs to be monitored, especially before and after receiving hematopoietic stem cell transplantation.

3. Bleeding risk: Monitor platelets, PT/aPTT, and fibrinogen during treatment.

4. QT interval prolongation: Regularly monitor electrocardiogram, especially when combined with other QT prolonging drugs.

7、 Medication for special populations

1. Pregnant women: Prohibited (may cause fetal damage).

2. Breastfeeding period: Stop breastfeeding during the treatment period and within one month after the last dose.

3. Children: Safe and effective for ages ≥ 2, insufficient data for ages<2.

8、 Adverse reactions

1. Common (≥ 20%): Fever (85%), Nausea (75%), Infection (65%), Thrombocytopenia (45%), VOD (14%).

2. Serious reactions: sepsis (10%), acute respiratory distress syndrome (5%), fatal bleeding (3%).

9、 Contraindications

It is contraindicated for individuals who are allergic to the ingredients of cetuximab or kanamycin.

10、 Drug interactions

1. Strong CYP3A inhibitors: may increase the toxicity of kanamycin and should be used with caution.

2. Antiplatelet/anticoagulant drugs: increase the risk of bleeding, avoid combination therapy.

11、 Storage method

Unopened penicillin bottles should be refrigerated at 2-8 ° C and stored away from light. After reconstitution, they should be used at room temperature for 6 hours or refrigerated for 24 hours.

12、 Manufacturer

Manufacturer: Pfizer Inc. (USA).

Note: During the treatment period, regular monitoring of blood routine, liver function, and heart function is necessary. If VOD symptoms (ascites, liver enlargement) or severe bleeding occur, medication should be stopped immediately.

Mylotarginformation