Can ozogamicin (gemtuzumab) cause liver problems?
Mar 21, 2022 · Gemtuzumab ozogamicin (GO), a humanized anti-CD33 monoclonal antibody conjugated to the cytotoxic antibiotic agent calicheamicin, is approved for the treatment of newly-diagnosed CD33 + AML in adults and children ≥ 1 month old, and relapsed or refractory CD33 + AML in adults and children ≥ 2 years old.
What foods should you not eat if you have cancer?
On September 1, 2017, the U.S. Food and Drug Administration approved gemtuzumab ozogamicin (Mylotarg, Pfizer Inc.) for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML ...
What are the doses of ozogamicin and Gemtuzumab during induction?
Gemtuzumab ozogamicin (GO) is an antibody-drug conjugate consisting of a monoclonal antibody targeting CD33 linked to a cytotoxic derivative of calicheamicin. Despite the known clinical efficacy in relapsed/refractory acute myeloid leukemia (AML), GO was withdrawn from the market in 2010 due to incr …
Is gemtuzumab ozogamicin a CD33?
Mar 05, 2018 · You should not breastfeed while you are receiving gemtuzumab ozogamicin injection, and for 1 month after your final dose. you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of receiving gemtuzumab ozogamicin. What special dietary instructions should I follow?
What is Gemtuzumab used for?
Gemtuzumab ozogamicin may be used in combination with daunorubicin and cytarabine for adults with newly-diagnosed AML, or as a stand-alone treatment for certain adult and pediatric patients.
When was gemtuzumab approved?
On September 1, 2017 , the U.S. Food and Drug Administration approved gemtuzumab ozogamicin (Mylotarg, Pfizer Inc.) for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and for treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older.
What age can you get AML?
Eligible patients had newly-diagnosed AML and were 1) greater than 75 years of age or 2) 61 to 75 years of age with a WHO performance status greater than 2 or were unwilling to receive intensive chemotherapy.
What to do if you are allergic to gemtuzumab?
Before receiving gemtuzumab ozogamicin injection, tell your doctor and pharmacist if you are allergic to gemtuzumab ozo gamicin, any other medications, or any of the ingredients in gemtuzumab ozogamicin injection. Ask your pharmacist for a list of the ingredients. tell your doctor and pharmacist what prescription and nonprescription medications, ...
What is Gemtuzumab used for?
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 and children 1 month of age and older who were recently found to have this cancer.
What are the side effects of a syringe?
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: 1 unusual or severe bleeding or bruising 2 cough, shortness of breath, or difficulty breathing 3 fast heartbeat 4 fever, chills, sore throat, or other signs of infection
How long does it take to get Gemtuzumab?
It is usually injected slowly over a period of 2 hours. Your doctor will tell you how often you will receive gemtuzumab ozogamicin injection.
Can you have a reaction to gemtuzumab?
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.
Can Gemtuzumab cause liver damage?
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 ...
What is Gemtuzumab used for?
This may help to protect healthy cells from damage. Gemtuzumab ozogamicin is used to treat a certain type (CD33-positive) of newly-diagnosed acute myeloid leukemia in adults and children at least 1 month old.
What are the side effects of a syringe?
bleeding; fever, infection; mouth sores; nausea, vomiting, constipation; headache; or. abnormal liver function tests. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Can Gemtuzumab cause liver damage?
Gemtuzumab ozogamicin can increase your risk of bleeding or liver damage, either of which may be life-threatening. Your cancer treatments may be delayed or permanently discontinued if you have certain side effects. Common side effects may include: bleeding; fever, infection; mouth sores; nausea, vomiting, constipation; headache; or.
What are the symptoms of liver problems?
signs of liver problems--right-sided upper stomach pain, jaundice (yellowing of the skin or eyes), rapid weight gain, swelling in your arms or legs, painful swelling in your midsection; low blood cell counts--fever, flu symptoms, swollen gums, skin sores, cough, trouble breathing, pale skin, unusual tiredness;
How long after birth control do you have to take a pregnancy test?
Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose. If you are a man, use effective birth control if your sex partner is able to get pregnant.
What does it mean when you have a bleed in your brain?
signs of bleeding in the brain--sudden numbness or weakness (especially on one side of the body), sudden severe headache, problems with speech or vision.
Can you breastfeed with gemtuzumab?
However, it is important to use birth control to prevent pregnancy because gemtuzumab ozogamicin may harm the baby if a pregnancy does occur. Do not breastfeed while using this medicine, and for at least 1 month after your last dose.
What is the cytotoxicity of GO?
GO cytotoxicity requires antibody-conjugate binding to the AML cell surface, followed by internalization, hydrolysis of the linker (allowing calicheamicin activation and release from the lysosome), and calicheamicin binding to DNA (inducing single- and double-strand breaks), followed by activation of downstream pathways leading to apoptotic cell death. Factors affecting each step have been identified and shown to influence GO effectiveness in vitro. 28 Critical factors identified in clinical studies include variation in CD33 expression and multidrug-resistance mechanisms.
When was gemtuzumab approved?
On 1 September 2017 , the US Food and Drug Administration (FDA) approved gemtuzumab ozogamicin (GO) for the treatment of adults with newly diagnosed CD33 + acute myeloid leukemia and for patients aged ≥2 years with CD33 + acute myeloid leukemia who have experienced a relapse or who have not responded to initial treatment.
Does calicheamicin bind to DNA?
To exert its cytotoxic effect, calicheamicin binds to the minor groove of DNA in a sequence-specific manner, inducing DNA single- and double-strand breaks that in turn initiate downstream pro- and antisurvival signaling events.
Foods to Avoid During Cancer Treatment
If your treatment has caused side effects like nausea, taste changes, or mouth sores, you probably have already started your own mental list of foods you'd much rather steer clear of. However, there are some foods that no matter how good they sound are probably best avoided due to the risk of foodborne illness, aka food poisoning.
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What is ozogamicin inotuzumab?
Inotuzumab ozogamicin is a monoclonal antibody linked to a chemotherapy drug. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.
What is inotuzumab used for?
Inotuzumab ozogamicin is used to treat a certain type of acute lymphocytic leukemia that has come back or has not responded after prior chemotherapy. Inotuzumab ozogamicin may also be used for purposes not listed in this medication guide.
How to know if you have a symtom?
Call your doctor at once if you have: 1 fever, weakness, cold or flu symptoms; 2 cough, trouble breathing; 3 swollen gums, mouth sores; 4 pale skin, easy bruising, skin sores; 5 a headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats; 6 signs of liver problems--upper stomach pain, jaundice (yellowing of the skin or eyes), or rapid weight gain, swelling in your arms or legs, painful swelling in your midsection; or 7 unusual bleeding--bleeding gums, abnormal vaginal bleeding, blood in your urine or stools, coughing up blood or vomit that looks like coffee grounds.
What are the symptoms of a fever?
Call your doctor at once if you have: fever, weakness, cold or flu symptoms; cough, trouble breathing; swollen gums, mouth sores; pale skin, easy bruising, skin sores; a headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
What are the side effects of a syringe?
fever; feeling tired; nausea, stomach pain; headache; or. abnormal laboratory tests. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Can inotuzumab affect fertility?
Tell your doctor right away if a pregnancy occurs while either the mother or the father is using inotuzumab ozogamicin. This medicine may affect fertility (ability to have children) in both men and women.