Chinese instructions for gemtuzumab/gemtuzumab (MYLOTARG)

1. Indications:Gemtuzumab/Gemtuzumab is used to treat patients with acute myeloid leukemia (AML). It is mainly suitable for the following situations:

1.Among newly treated AML patients, CD33 positive AML.

2.RelapsedAMLpatients, or AMLpatients who cannot tolerate traditional treatments (such as chemotherapy).

2. Mechanism of action:Gemtuzumab/Gemtuzumab is a monoclonal antibody drug. Its mechanism of action includes:

1.Selectively bindsCD33antigen:Gemtuzumab/Gemtuzumab can specifically bind to the CD33 antigen on the surface of AML cells.

2.Induces immune cell attack: Oncegemtuzumab/gemtuzumab binds to CD33antigen, it activates the host Immune cells, such as natural killer cells (NK cells) and macrophages, direct them to attack and kill CD33-positive AML cells.

3. Pharmacology:Gemtuzumab/The pharmacological characteristics of gemtuzumab include:

1.Absorption and distribution:Gemtuzumab/GemtuzumabAdministered via intravenous injection and rapidly distributed throughout the body.

2.Metabolism and excretion:Gemtuzumab/The metabolism and excretion of gemtuzumab are unknown.

3.Drug concentration monitoring: Usually there is no need to monitor blood drug concentration.

4. Dosage and dosage: The usage and dosage should be determined according to the patient's specific condition and the doctor's advice. Common usage includes:

1.Initial treatment: In accordance with the doctor's prescription, intravenous injection of gemtuzumab/gemtuzumab within a specific treatment cycle.

2.Dose adjustment: Doctors may adjust the dosage and treatment regimen of gemtuzumab/gemtuzumab based on the patient's response and tolerance.

5. Side effects:Gemtuzumab/GemtuzumabPossible side effects include but are not limited to:

1.Fever, headache, nausea and vomiting.

2.Blood system problems, such as anemia, thrombocytopenia, leukopenia, etc.

3.Abnormal liver function.

4.Adverse reactions related to the immune system, such as increased risk of infection.

5.Cardiovascular system problems, such as tachycardia, hypertension, etc.

6. Warnings and Precautions: Patients need to pay special attention to the following matters when usinggemtuzumab/gemtuzumab:

1.It needs to be used under the supervision of a doctor. Do not change the dosage or stop treatment on your own.

2.Monitor blood routine and liver function.

3.Pregnant and breastfeeding women need to consult a doctor because Gemtuzumab/Gemtuzumab may have effects on the fetus or infant.

7. Contraindications:Gemtuzumab/GemtuzumabContraindications include patients who are allergic to the drug or its ingredients.

8. Drug interactions: There are currently no clear reports of drug interactions. However, patients should avoid unnecessary use of other drugs, especially drugs with potential hepatotoxicity, during treatment with gemtuzumab/getuzumab.

9. Medication for special groups:

1.Elderly patients: Elderly patients require close monitoring when taking gemtuzumab/gemtuzumab because they may have different reactions to the metabolism and tolerability of the drug.

2.Children and Adolescents:Gemtuzumab/The safety and effectiveness of gemtuzumab in children and adolescents have not been established.

10. Listing and Price Status: Gemtuzumab/Gemtuzumab is not currently available in the country, so it cannot be included in medical insurance. Patients cannot purchase it domestically and need to purchase gemtuzumab through overseas channels./Gemtuzumab. Gemtuzumab abroad/The only gemtuzumab available is Pfizer's original drug, which is expensive. The cheaper ones are mainly Turkish original drugs, which cost 45 000yuan, and the price of the original drug in Hong Kong, China is around 65,000yuan, and the ingredients and efficacy of the original drug are consistent.