Gemtuzumab Ozogamicin

Pediatric Medication

Brand Names: US

Mylotarg

Warning

  • Liver problems have happened with this drug. Sometimes, this has been life-threatening or deadly. The chance of liver problems is higher in people who had a stem cell transplant before or after treatment with this drug. It is also higher in people who have already had liver problems and in people getting higher doses of this drug. Tell your child’s doctor if your child has ever had liver problems or a stem cell transplant.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.

What is this drug used for?

  • It is used to treat leukemia.

What do I need to tell the doctor BEFORE my child takes this drug?

  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

If your child is breast-feeding a baby:

  • Be sure your child does not breast-feed a baby while taking this drug and for 1 month after stopping this drug.

This drug may interact with other drugs or health problems.

Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while my child takes this drug?

  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Your child may bleed more easily. Make sure your child is careful and avoids injury. Be sure your child has a soft toothbrush. Rarely, some bleeding problems have been deadly.
  • Your child may have more chance of getting infections. Have your child wash hands often. Avoid crowds and people with infections, colds, or flu.
  • Talk with the doctor before your child gets any vaccines. Use with this drug may either raise the chance of very bad infection or make the vaccine not work as well.
  • Infusion reactions have happened with this drug. Sometimes, these could be very bad or life-threatening. Talk with the doctor.
  • Infusion reactions can happen up to 24 hours after this drug is given.
  • This drug may affect fertility. Fertility problems may lead to not being able to get pregnant or father a child. Talk with the doctor.
  • If your child is of childbearing age, a pregnancy test will need to be done before starting this drug to make sure she is not pregnant.

If your child is or may be sexually active:

  • Have your child use birth control to prevent pregnancy while taking this drug and for 6 months after stopping this drug.
  • If your child is a male and has sex with a female who could get pregnant, they must prevent pregnancy during care and for 3 months after care ends. They must use birth control that can be trusted.
  • If your child is a male and his sex partner gets pregnant while he takes this drug or within 3 months after his last dose, call the doctor right away.

If your child is pregnant:

  • This drug may cause harm to the unborn baby if your child takes it during pregnancy.
  • If your child gets pregnant while taking this drug or within 6 months after her last dose, call the doctor right away.

What are some side effects that I need to call my child’s doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
  • Stomach swelling or fast weight gain.
  • Fever or chills.
  • A fast heartbeat.
  • A heartbeat that does not feel normal.
  • Very bad dizziness or passing out.
  • Shortness of breath.
  • Not able to pass urine or change in how much urine is passed.
  • This drug can cause a very bad and sometimes deadly bowel problem (neutropenic enterocolitis). Call the doctor right away if your child has stomach pain with or without a fever.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:

  • Upset stomach or throwing up.
  • Hard stools (constipation).
  • Mouth irritation or mouth sores.
  • Headache.
  • Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.

You may report side effects to your national health agency.

How is this drug best given?

Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.

  • It is given as an infusion into a vein over a period of time.
  • Other drugs will be given with this drug to help avoid side effects.

What do I do if my child misses a dose?

  • Call your child’s doctor to find out what to do.

How do I store and/or throw out this drug?

  • If you need to store this drug at home, talk with your child’s doctor, nurse, or pharmacist about how to store it.

General drug facts

  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with the doctor before giving your child any new drug, including OTC, natural products, or vitamins.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Last Reviewed Date

2017-09-18

Copyright

© 2018 Wolters Kluwer Clinical Drug Information, Inc. and its affiliates and/or licensors. All rights reserved.

Last Updated