Use under supervision of a qualified clinician experienced in treatment of acute leukemia in facilities equipped to monitor and treat leukemia patients.
Combined Therapy
Use only as single-agent chemotherapy and not in combination chemotherapy regimens outside of clinical trial setting. Controlled trials have failed to demonstrate efficacy and safety in combination with other chemotherapeutic agents. (See Acute Myeloid Leukemia [AML] under Uses.)
Myelosuppression
Risk of severe myelosuppression at recommended dosages. (See Myelosuppression under Cautions.)
Hypersensitivity
Possible severe, potentially fatal hypersensitivity reactions (e.g., anaphylaxis); strongly consider discontinuance if anaphylaxis develops.
Infusion Reactions
Possible infusion reactions, including severe, potentially fatal pulmonary events; most infusion-related symptoms occur during infusion or within 24 hours of administration and resolve. Interrupt infusion in patients experiencing dyspnea or clinically important hypotension; monitor until manifestations completely resolve. Strongly consider discontinuance if pulmonary edema or acute respiratory distress syndrome develops. (See Pulmonary Reactions under Cautions.)
Leukoreduction
Risk for pulmonary events and tymor lysis syndrome may be greater in patients with high peripheral blast counts; consider leukoreduction with hydroxyurea or leukapheresis to reduce peripheral leukocyte count to <30,000/mm3 prior to administration.
Hepatotoxicity
Possible hepatotoxicity; risk for developing hepatic veno-occlusive disease (VOD), including severe VOD, is increased in patients who receive gemtuzumab ozogamicin either before or after hematopoietic stem-cell transplant (HSCT), patients with underlying hepatic disease or hepatic impairment, and patients receiving gemtuzumab ozogamicin in combination with other chemotherapy. Hepatic failure and VOD have been fatal in some cases. Monitor carefully for manifestations, particularly VOD (e.g., rapid weight gain, right upper quadrant pain, hepatomegaly, ascites, elevations in bilirubin and/or liver enzymes); however, careful monitoring may not identify all patients at risk or prevent complications. (See Hepatotoxicity under Cautions.)
GEMTUZUMAB OZOGAMICIN (jem TOOZ oo mab OH zoe ga MYE sin) is a monoclonal antibody. This medicine changes the way the body's immune system works. By interfering with a specific protein, this medicine can stop cancer cell growth. It is used to treat acute myelogenous leukemia (AML).
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
This medicine is for infusion into a vein. It is administered in a hospital or clinic by a specially trained health care professional.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
It is important not to miss a dose. Call your doctor or health care professional if you are unable to keep an appointment.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.
Drink fluids as directed while you are taking this medicine to prevent kidney damage.
Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.
This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.
Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.
Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.
Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.
signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine
signs of decreased red blood cells - unusually weak or tired, fainting spells, lightheadedness
breathing problems
fast, irregular heartbeat
feeling faint or lightheaded, falls
low blood pressure
mouth sores
right upper belly pain
stomach pain
sudden weight gain
trouble passing urine or change in the amount of urine
vomiting
Side effects that usually do not require medical attention (report to your doctor or other health care professional if they continue or are bothersome):
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
This drug is given in a hospital or clinic and will not be stored at home.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
