Gemtuzumab (Intravenous)
Medically reviewed by Drugs.com. Last updated on Mar 26, 2022.
Hepatotoxicity, including severe or fatal hepatic 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. Monitor frequently for signs and symptoms of VOD after treatment with gemtuzumab ozogamicin
Commonly used brand name(s)
In the U.S.
- Mylotarg
Available Dosage Forms:
- Powder for Solution
Therapeutic Class: Antineoplastic Agent
Pharmacologic Class: Antibody Drug Conjugate
Uses for gemtuzumab
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 alone to treat CD33-positive AML that has come back (relapsed) or after other medicines did not work well (refractory).
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 gemtuzumab as well as the possible risks of using it.
Gemtuzumab is to be given only by or under the direct supervision of your doctor.
Before using gemtuzumab
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 gemtuzumab, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to gemtuzumab 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 gemtuzumab.
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 breastfeed..
