How it is administered

Gemtuzumab ozogamicin is given as an intravenous (IV) infusion, meaning it is administered directly into a vein. It is supplied as a sterile, white to off-white powder that is reconstituted and diluted before use. The medication is dosed based on body surface area (mg/m²) and is given on specific days, depending on the treatment regimen (for example, Days 1, 4, and 7 for certain protocols). The infusion is typically administered over 2 hours and must be protected from light during administration.

How it works

Gemtuzumab ozogamicin is a type of targeted therapy known as an antibody-drug conjugate. It consists of an antibody that specifically binds to the CD33 antigen, which is commonly found on the surface of acute myeloid leukemia (AML) cells. Attached to this antibody is a potent chemotherapy agent called N-acetyl gamma calicheamicin.

When gemtuzumab ozogamicin binds to CD33-positive cells, the entire complex is taken into the cancer cell. Inside the cell, the chemotherapy component is released, causing breaks in the cell's DNA, which leads to cell cycle arrest and programmed cell death (apoptosis). This targeted approach helps to deliver the chemotherapy directly to the leukemia cells, potentially reducing damage to normal cells.

Who Should take it

Gemtuzumab ozogamicin is indicated for patients with CD33-positive acute myeloid leukemia (AML). It can be used in adults and children (as young as 1 month old) who have newly diagnosed AML, as well as in adults and children (2 years and older) with relapsed or refractory AML.

The medication may be used alone or in combination with other chemotherapy drugs, depending on the patient's specific situation and health status. It is important that the leukemia cells express the CD33 antigen, as the drug specifically targets this marker.

Who should not take it

Gemtuzumab ozogamicin should not be used in patients who have a known hypersensitivity or allergy to the active substance or any of its components. This includes patients who have experienced anaphylactic reactions to the medication in the past.

Additionally, it should be used with caution or avoided in patients with significant liver impairment, as the risk of severe liver toxicity (including veno-occlusive disease) is increased. Pregnant women should not use this medication due to the risk of harm to the unborn baby. Always inform your healthcare provider of your full medical history before starting treatment.

Commonly used with

Gemtuzumab ozogamicin is often used in combination with other chemotherapy drugs, particularly daunorubicin and cytarabine, for the treatment of newly diagnosed AML. The combination regimen is determined by the treating physician based on the patient's age, health status, and specific characteristics of the leukemia.

In some cases, it may be used as a single agent, especially in patients who are not able to tolerate intensive chemotherapy.

Commonly tested with

In clinical studies, gemtuzumab ozogamicin has been tested in combination with standard chemotherapy agents such as daunorubicin and cytarabine for newly diagnosed AML. It has also been studied as a single agent in patients with relapsed or refractory AML.

Additionally, it may be given as part of a treatment plan that includes supportive care medications to manage side effects, such as corticosteroids, acetaminophen, and antihistamines to prevent infusion-related reactions.