Skip to main content

Gemtuzumab ozogamicin

Details of the Drug
Generic Name:
Gemtuzumab ozogamicin
gem-TOO-zoo-mab OH-zoh-ga-MIH-sin
Drug Type:
CD33-directed antibody and cytotoxic drug conjugate
How the Drug is Given:

Intravenously (IV)

Gemtuzumab ozogamicin

Indications and Usage

Gemtuzumab ozogamicin is approved for the treatment of

  • Newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older 
  • Relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older (1.2).

Side effects needing medical attention

The most common adverse reactions (greater than 15%) were hemorrhage, infection, fever, nausea, vomiting, constipation, headache, increased AST (sign of liver damage), increased ALT (sign of liver damage), rash, mucositis (mouth sores), febrile neutropenia (fever, often with signs of infection, in a patient with neutropenia [a low number of a type of white blood cells] in the blood), and decreased appetite.

The prescribing information for Mylotarg includes a boxed warning that severe or fatal liver damage (hepatotoxicity), including blockage of veins in the liver (veno-occlusive disease or sinusoidal obstruction syndrome), occurred in some patients who took Mylotarg.

For information on how to manage the costs of drug therapy, please see Financial Support, or to speak with an Information Specialist, call (800) 955-4572.