Gemtuzumab Ozogamicin Injection
(jem tooz' ue mab oh" zoe ga mye' sin)
Gemtuzumab ozogamicin injection may cause severe or life-threatening liver damage, including hepatic veno-occlusive disease (VOD; blocked blood vessels inside the liver). Tell your doctor if you have or have ever had liver disease or have had a hematopoietic stem-cell transplant (HSCT; procedure that replaces diseased bone marrow with healthy bone marrow). If you experience any of the following symptoms, call your doctor immediately: rapid weight gain, pain or swelling in the upper right part of the stomach, yellowing of the skin or eyes, nausea, vomiting, dark colored urine, or extreme tiredness.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests before, during, and after your treatment to check your body's response to gemtuzumab ozogamicin injection.
Talk to your doctor about the risks of taking gemtuzumab ozogamicin injection.
WHY is this medicine prescribed?
Gemtuzumab ozogamicin injection is used alone or in combination with other chemotherapy medications to treat a certain type of acute myeloid leukemia (AML; a type of cancer that begins in the white blood cells) in adults whose cancer was never treated before. It is also used alone to treat a certain type of AML in adults and children 2 years of age and older whose cancer worsened during or after treatment with other chemotherapy medications. Gemtuzumab ozogamicin injection is in a class of medications called monoclonal antibodies. It works by helping to kill cancer cells.
HOW should this medicine be used?
Gemtuzumab ozogamicin injection comes as a powder to be mixed with liquid and given through a needle or catheter placed into a vein. It is usually injected slowly over a period of 2 hours. Your doctor will tell you how often you will receive gemtuzumab ozogamicin injection. The dosing schedule depends on if you are being treated with other chemotherapy medications, if your cancer was previously treated, and how your body responds to the medication.
Gemtuzumab ozogamicin injection may cause serious or life-threatening reactions during an infusion and for up to a day afterwards. You will receive certain medications to help prevent a reaction before you receive each dose of gemtuzumab ozogamicin. A doctor or nurse will watch you closely while you are receiving the infusion and shortly after the infusion to be sure you are not having a serious reaction to the medication. Tell your doctor or nurse immediately if you experience any of the following symptoms that may occur during or within 24 hours after the infusion: rash, fever, chills, fast heartbeat, swollen tongue or throat, shortness of breath or difficulty breathing.
Your doctor may slow down your infusion, delay, or stop your treatment with gemtuzumab ozogamicin injection, or treat you with additional medications depending on your response to the medication and any side effects that you experience. Talk to your doctor about how you are feeling during and after your treatment.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking gemtuzumab ozogamicin injection,
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What SIDE EFFECTS can this medicine cause?
Gemtuzumab ozogamicin injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:
Gemtuzumab ozogamicin injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( http://www.fda.gov/Safety/MedWatch ) or by phone (1-800-332-1088).
What OTHER INFORMATION should I know?
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: February 15, 2018.
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