Gemtuzumab Ozogamicin (Mylotarg®)

About This Drug

Gemtuzumab ozogamicin is used to treat cancer. It is given in the vein (IV).

Possible Side Effects

  • Abnormal bleeding – symptoms may be coughing up blood, throwing up blood (may look like coffee grounds), red or black tarry bowel movements, abnormally heavy menstrual flow, nosebleeds or any other unusual bleeding.
  • Infection
  • Fever
  • Nausea and throwing up (vomiting)
  • Constipation (not able to move bowels)
  • Soreness of the mouth and throat. You may have red areas, white patches, or sores that hurt.
  • Headache
  • Changes in your liver function. Your liver function will be checked as needed.
  • Rash

Note: Each of the side effects above was reported in 15% or greater of patients treated with gemtuzumab ozogamicin. Not all possible side effects are included above.

Warnings and Precautions

  • Severe changes in your liver function, which can very rarely cause liver failure and be fatal. Patients who have received, or will receive a stem cell transplant may be at an increased risk.
  • While you are getting this drug in your vein (IV), you may have a reaction to the drug. Sometimes you may be given medication to stop or lessen these side effects. Your nurse will check you closely for these signs: fever or shaking chills, flushing, facial swelling, feeling dizzy, headache, trouble breathing, rash, itching, chest tightness, or chest pain. These reactions may happen after your infusion. If this happens, call 911 for emergency care.
  • Severe abnormal bleeding which can very rarely be fatal.
  • Abnormal heart beat/EKG.

Important Information

  • This drug may be present in the saliva, tears, sweat, urine, stool, vomit, semen, and vaginal secretions. Talk to your doctor and/or your nurse about the necessary precautions to take during this time.

Treating Side Effects

  • Ask your doctor or nurse about medicines that are available to help stop or lessen constipation.
  • If you are not able to move your bowels, check with your doctor or nurse before you use enemas, laxatives, or suppositories.
  • Drink plenty of fluids (a minimum of eight glasses per day is recommended).
  • To help with nausea and vomiting, eat small, frequent meals instead of three large meals a day. Choose foods and drinks that are at room temperature. Ask your nurse or doctor about other helpful tips and medicine that is available to help or stop lessen these symptoms.
  • Mouth care is very important. Your mouth care should consist of routine, gentle cleaning of your teeth or dentures and rinsing your mouth with a mixture of 1/2 teaspoon of salt in 8 ounces of water or ½ teaspoon of baking soda in 8 ounces of water. This should be done at least after each meal and at bedtime.
  • If you have mouth sores, avoid mouthwash that has alcohol. Also avoid alcohol and smoking because they can bother your mouth and throat.
  • If you get a rash do not put anything on it unless your doctor or nurse says you may. Keep the area around the rash clean and dry. Ask your doctor for medicine if your rash bothers you.
  • Infusion reactions may occur after your infusion. If this happens, call 911 for emergency care.

Food and Drug Interactions

  • There are no known interactions of gemtuzumab ozogamicin with food or with other medications.
  • Tell your doctor and pharmacist about all the medicines and dietary supplements (vitamins, minerals, herbs and others) that you are taking at this time.

When to Call the Doctor

Call your doctor or nurse if you have any of these symptoms and/or any new or unusual symptoms:

  • Fever of 100.5 F (38 C) or higher
  • Chills
  • Easy bleeding or bruising
  • Blood in your urine, vomit (bright red or coffee-ground) and/or stools ( bright red, or black/tarry)
  • Coughing up blood
  • Feeling that your heart is beating in a fast or not normal way (palpitations)
  • Pain in your mouth or throat that makes it hard to eat or drink
  • Nausea that stops you from eating or drinking and/or is not relieved by prescribed medicines
  • Throwing up more than 3 times a day
  • Loose bowel movements (diarrhea) 4 times a day or loose bowel movements with lack of strength or a feeling of being dizzy
  • New rash and/or itching
  • Rash that is not relieved by prescribed medicines
  • Signs of possible liver problems: dark urine, pale bowel movements, , feeling very tired and weak, unusual itching, yellowing of the eyes or skin, rapid weight gain, or right upper abdomen pain and tenderness
  • Signs of infusion reaction: fever or shaking chills, flushing, facial swelling, feeling dizzy, headache, trouble breathing, rash, itching, chest tightness, or chest pain.
  • If you think you may be pregnant or may have impregnated your partner

Reproduction Warnings

  • Pregnancy warning: This drug can have harmful effects on the unborn baby. Women of child bearing potential should use effective methods of birth control during your cancer treatment and for at least 6 months after treatment. Men with female partners of child bearing potential should use effective methods of birth control during your cancer treatment and for at least 3 months after your cancer treatment. Let your doctor know right away if you think you may be pregnant or may have impregnated your partner
  • Breastfeeding warning: It is not known if this drug passes into breast milk. Women should not breast feed during treatment and for 1 month after treatment because this drug could enter the breast milk and cause harm to a breast feeding baby.
  • Fertility warning: In men and women both, this drug may affect your ability to have children in the future. Talk with your doctor or nurse if you plan to have children. Ask for information on sperm or egg banking.

Revised September 2017