Before Using

Drug information provided by: Merative, Micromedex®

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of gemtuzumab injection together with other medicines in children 1 month of age and older with newly-diagnosed AML. Safety and efficacy have not been established in children with newly-diagnosed AML to receive gemtuzumab injection alone.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of gemtuzumab injection in children 2 years of age and older with relapsed or refractory AML. Safety and efficacy have not been established children younger than 2 years of age with relapsed or refractory AML.

Geriatric

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.

Breastfeeding

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.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Varicella Virus Vaccine, Live
  • Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Adenovirus Vaccine, Live
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Cholera Vaccine, Live
  • Dengue Tetravalent Vaccine, Live
  • Ebola Zaire Vaccine, Live
  • Influenza Virus Vaccine, Live
  • Levoketoconazole
  • Methotrexate
  • Pexidartinib
  • Poliovirus Vaccine, Live
  • Smallpox Monkeypox Vaccine, Live Non-Replicating
  • Smallpox Vaccine
  • Typhoid Vaccine, Live
  • Yellow Fever Vaccine

Other Interactions

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.

Other Medical Problems

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.

Portions of this document last updated: Feb. 01, 2024

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