Gemtuzumab (Intravenous Route)

Gemtuzumab injection is used alone or together with other medicines (eg, cytarabine, daunorubicin) to treat newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults. It is also used to treat CD33-positive AML that has come back or after other medicines did not work well, in adults and children 2 years of age and older.

Gemtuzumab is an antineoplastic (cancer) medicine. It interferes with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal cells may also be affected by gemtuzumab, other side effects can occur. Before you begin treatment, talk to your doctor about the benefits of this medicine as well as the possible risks of using it.

This medicine is to be given only by or under the direct supervision of your doctor.

This product is available in the following dosage forms:

• Powder for Solution

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gemtuzumab injection in the elderly. However, elderly patients are more likely to have high fever or serious infections, which may require caution in patients receiving this medicine.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Electrolyte imbalance or
• Liver disease, moderate or severe or
• Patients who have had hematopoietic stem cell transplant (HSCT)—Use with caution. May cause side effects to become worse.

• Heart rhythm problems (including QT prolongation), history of—Use with caution. May make this condition worse.

• Hyperleukocytosis (blood problem)—Surgical removal of cancer cells is recommended before starting treatment with gemtuzumab.