How it Works

Gemtuzumab ozogamicin is a recombinant humanized IgG4 kappa antibody. An antibody is a protein, which is a natural part of the immune system that helps fight off infections and diseases. The antibody in gemtuzumab ozogamicin has been "humanized" and modified in a laboratory to make it more effective against acute myeloid leukemia (AML) cells.

Gemtuzumab ozogamicin works by attaching to a protein called CD33, which is found on the surface of many AML cells. Once the drug is attached to the AML cell, it releases a chemical called calicheamicin, which can kill the cancer cell. Calicheamicin is a type of antibiotic that is made from a type of bacteria called Micromonospora echinospora ssp. calichensis.

How it’s Administered

• Is given as an intravenous infusion (through a vein); dosage depends on the regimen and the weight of the patient. 

Who Should Take Gemtuzumab Ozogamicin

• Newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older
• Adults and children who are 2 years old or older, and who have CD33-positive AML that has come back (relapsed) or has not responded to other treatments (refractory).

Who Shouldn’t Take Gemtuzumab Ozogamicin 

• Pregnant women. It is important to inform your healthcare provider if you are pregnant, or planning to become pregnant before starting treatment, as it may cause harm to the fetus.
• Breastfeeding women should suspend breastfeeding if they start taking this medication. 
• Patients with blood disorders or a low platelet count may not be able to have this treatment
• Patients with a history of liver or kidney problems may not be eligible for this therapy.
• Patients diagnosed with Long QT syndrome (LQTS). A rare inherited heart rhythm disorder that can cause potentially life-threatening irregular heartbeats, known as arrhythmias.
• People who are allergic to the medication or any of its components

The Most Common Side Effects of Taking Gemtuzumab Ozogamicin Include:

• Decreased blood cell counts: Your levels of platelets, white and red blood cells may temporarily drop. Which may cause, fatigue, weakness, shortness of breath, increased risk of infections, bleeding or bruising. 
• Fever, infection, increased liver enzymes, bleeding
• Nausea, vomiting, constipation, mucositis 
• QT interval prolongation electrocardiogram 
• Warning: liver toxicity, including severe or fatal liver veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of Gemtuzumab ozogamicin as a single agent, and as part of a combination chemotherapy regimen.

Commonly Used in Acute Myeloid Leukemia With

• Daunorubicin and cytarabine for the treatment of AML in adults.
• It may be used as a stand-alone treatment for certain adult and pediatric patients.

TAKE A LOOK AT THE AVAILABLE CLINICAL TRIALS FOR AML

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Date last updated: 12/22/22