How it is administered

Gemtuzumab ozogamicin is given as an intravenous (IV) infusion. It comes as a sterile, white to off-white powder that is reconstituted and diluted before administration. The medication is administered in a hospital or clinic setting by a healthcare professional. Dosing varies depending on the patient's age, body surface area, and whether it is used alone or in combination with other chemotherapy drugs. Premedication with a corticosteroid, acetaminophen, and an antihistamine is recommended to reduce the risk of infusion-related reactions.

How it works

Gemtuzumab ozogamicin is a 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 certain leukemia cells, particularly in acute myeloid leukemia (AML). Once attached to the CD33-positive cells, the antibody is internalized, and the attached cytotoxic agent (calicheamicin) is released inside the cell. This cytotoxic agent causes double-strand breaks in the DNA, leading to cell cycle arrest and programmed cell death (apoptosis) of the cancerous cells.

By targeting CD33, gemtuzumab ozogamicin delivers chemotherapy directly to the leukemia cells, aiming to minimize damage to normal cells and improve treatment outcomes for patients with CD33-positive AML.

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) with newly diagnosed AML, as well as in adults and children (2 years and older) with relapsed or refractory AML. The medication can be given alone or in combination with other chemotherapy agents, depending on the specific clinical situation.

Your healthcare provider will determine if your leukemia cells express the CD33 antigen and if gemtuzumab ozogamicin is appropriate for your treatment plan. It is especially considered for patients who may not tolerate intensive chemotherapy or who have relapsed after previous treatments.

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 any history of severe allergic reactions, such as anaphylaxis, to gemtuzumab ozogamicin or its excipients.

It is also not recommended for use during pregnancy, as it can cause harm to the unborn baby. Women who are pregnant or planning to become pregnant should discuss alternative treatment options with their healthcare provider. Additionally, caution is needed in patients with moderate or severe liver impairment, as the risk of serious liver complications is higher.

Commonly used with

Gemtuzumab ozogamicin is often used in combination with other chemotherapy medications, especially daunorubicin and cytarabine, for the treatment of newly diagnosed AML. The combination is tailored based on the patient's age, health status, and specific characteristics of their leukemia.

It may also be used as a single agent in certain situations, such as in patients who are not candidates for intensive chemotherapy or who have relapsed or refractory disease.

Commonly tested with

In clinical studies, gemtuzumab ozogamicin has been tested in combination with standard chemotherapy regimens, including daunorubicin and cytarabine, in both adults and children with AML. It has also been evaluated as a single agent in patients with newly diagnosed or relapsed/refractory AML.

Research continues to explore its use with other agents and in different patient populations to further improve outcomes for people with blood cancers.