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    Mylotarg Vial

    GENERIC NAME(S): Gemtuzumab Ozogamicin

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    WARNINGS:

    This medication may cause very serious (even fatal) liver damage, including a certain type known as veno-occlusive disease (VOD). The risk is increased with higher doses, or if you already have liver problems, or if you have had a bone marrow transplant. Careful monitoring by your doctor may decrease your risk. Tell your doctor right away if you develop nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine, swelling abdomen, sudden weight gain. Your doctor may change your dosage schedule or stop treatment with this medication if you develop VOD.

    Who should not take Mylotarg Vial?
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    Uses

    This medication is used to treat a certain type of leukemia (CD33-positive acute myeloid leukemia-AML). This medication works by slowing or stopping the growth of cancer cells.

    How to use Mylotarg Vial

    This medication is given by slow injection into a vein as directed by your doctor, usually over 2 hours. To decrease the risk of side effects, your doctor may give you other medications (such as acetaminophen, diphenhydramine) before your injection. The dosage and treatment schedule are based on your medical condition, response to treatment, and body size.

    To get the most benefit from this medication, do not miss any doses. To help you remember, mark the days on the calendar when you need to receive the medication.

    Side Effects

    See also Warning section.

    Nausea, vomiting, constipation, or headache may occur. Pain or sores in the mouth and throat may occur. Brush your teeth carefully/gently, avoid using mouthwash that contains alcohol, and rinse your mouth often with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

    This medication may cause a serious infusion reaction. If this happens, it is usually while the drug is being given or within 24 hours of the dose. If you have chills, fever, trouble breathing, or severe dizziness, tell your doctor or pharmacist right away because your injection may need to be stopped.

    People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside effects. Careful monitoring by your doctor may decrease your risk.

    This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

    Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding.

    Get medical help right away if you have any very serious side effects, including: fast/irregular heartbeat, severe dizziness, signs of bleeding (such as pink/bloody urine, dark/tarry stools, vomit that looks like coffee grounds), symptoms of bleeding in the brain (such as dizziness/fainting, sudden vision changes, nausea, seizures, confusion).

    A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

    This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

    In the US -

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

    Precautions

    Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

    Before using this medication, tell your doctor or pharmacist your medical history, especially of: other blood/bone marrow disorders (such as increased white blood cell count), bone marrow transplant, liver disease, recent/current infection.

    This medication can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

    Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

    To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

    This medication may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

    The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using gemtuzumab ozogamicin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

    Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using this medication safely.

    Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

    Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

    Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using this medication. Gemtuzumab ozogamicin may harm an unborn baby. Women should ask about reliable forms of birth control while using this medication and for at least 6 months after stopping treatment. Men should use reliable forms of birth control while using this medication and for at least 3 months after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

    It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for at least 1 month after stopping treatment is not recommended. Consult your doctor before breast-feeding.

    Interactions

    Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

    Overdose

    If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

    Notes

    Lab and/or medical tests (such as complete blood count, liver function) should be done while you are using this medication. Keep all medical and lab appointments.

    Missed Dose

    For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish a new dosing schedule.

    Storage

    Not applicable. This medication is given in a hospital or clinic and will not be stored at home.Information last revised October 2017. Copyright(c) 2017 First Databank, Inc.

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    Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

    CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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