Gemtuzumab Ozogamicin Injection (GEMTUZUMAB OZOGAMICIN - INJECTION)

For treating cancer.

Brand Name(s): Mylotarg

Generic Name: Gemtuzumab Ozogamicin

Instructions

This medicine is given as an IV injection into a vein.

This medicine should be given over 2 hours.

This medicine should be given by a trained health care provider.

Tell your doctor if you have severe or persistent sweating, diarrhea or vomiting. These can increase your risk of a serious side effect.

If you miss a dose, contact your doctor for instructions.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Your doctor may prescribe other medications to reduce side effects. Follow instructions carefully.

Talk to your doctor before taking other medicines, including aspirins and ibuprofen containing products. Speak to your doctor about which medicines are safe to use while you are on this medicine.

Keep using this medicine for the full number of days that it is prescribed. Do not stop the medicine even if you start to feel better.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

May cause mouth sores. Brush teeth gently. Avoid products containing alcohol. Rinse mouth with a mixture of water and baking soda or salt.

Some patients on this medicine have developed severe, life-threatening infections. Please speak with your doctor about the risks and benefits of using this medicine.

Some patients taking this medicine have experienced serious side effects. Please speak with your doctor to understand the risks and benefits associated with this medicine.

This medicine is associated with a rare, but serious problem of the liver. Speak to your doctor about the early signs of liver problems and the benefits and risks of using this medicine.

Tell your doctor or nurse right away if fever, chills, severe dizziness, or shortness of breath develop while the medicine is being given. The medicine may need to be stopped or given at a slower rate.

Do not drink beverages with alcohol while on this medicine.

This medicine may reduce your body's ability to fight infections. Avoid contact with people with colds, flu or other infections. Contact your doctor if you develop fever, cough, sore throat, or chills.

Speak with your health care provider before receiving any vaccinations.

Do not breastfeed while on this medicine. You may safely start breastfeeding 1 month after stopping treatment.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Women must use reliable forms of birth control while taking this medicine and for 6 months after stopping to prevent pregnancy.

Men with a female partner who is of childbearing age must use a condom and a second form of birth control during sexual activity while taking this medicine and for 3 months after stopping to prevent pregnancy.

Always carry an ID card or wear a medical alert bracelet indicating your medical condition.

Call your doctor right away if you notice any unusual bleeding or bruising.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • constipation
  • headaches
  • mouth sores or irritation
  • nausea and vomiting
  • stomach upset or abdominal pain

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • bleeding or bruising
  • confusion
  • cough that does not go away
  • coughing up blood or vomit that looks like coffee grounds
  • fainting
  • fever or chills
  • fast or irregular heart beats
  • signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
  • seizures
  • shortness of breath
  • sore throat
  • bloody or dark, tarry stools
  • symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
  • blood in urine
  • sudden change or loss of vision

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.

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