Inotuzumab Ozogamicin (Besponsa®)

About This Drug

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

Possible Side Effects

  • Bone marrow depression. This is a decrease in the number of white blood cells, red blood cells, and platelets. This may raise your risk of infection, make you tired and weak (fatigue), and raise your risk of bleeding.
  • Infections
  • Fever, which can be in the setting of decreased white blood cells and put you at an increased risk of infections.
  • Tiredness
  • 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.
  • Nausea
  • Pain in your abdomen
  • Headache
  • Changes in your liver function. Your liver function will be checked as needed.

Note: Each of the side effects above was reported in 20% or greater of patients treated with inotuzumab ozogamicin. Not all possible side effects are included above.

Warnings and Precautions

  • Changes in your liver function, which can very rarely lead to liver failure and be fatal.
  • Abnormal heart beat
  • Increased risk of complications and death in patients who will undergo a stem cell transplant after receiving inotuzumab ozogamicin.
  • Severe bone marrow depression which can very rarely be fatal.
  • 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.

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

  • Manage tiredness by pacing your activities for the day.
  • Be sure to include periods of rest between energy-draining activities.
  • To help decrease infection, wash your hands regularly.
  • Avoid close contact with people who have a cold, the flu, or other infections.
  • Take your temperature as your doctor or nurse tells you, and whenever you feel like you may have a fever.
  • To help decrease bleeding, use a soft toothbrush. Check with your nurse before using dental floss.
  • Be very careful when using knives or tools.
  • Use an electric shaver instead of a razor.
  • Drink plenty of fluids (a minimum of eight glasses per day is recommended).
  • If you throw up or have loose bowel movements, you should drink more fluids so that you do not become dehydrated (lack water in the body from losing too much fluid).
  • 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.
  • Keeping your pain under control is important to your well-being. Please tell your doctor or nurse if you are experiencing pain.
  • 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 inotuzumab ozogamicin with food.
  • Check with your doctor or pharmacist about all other prescription medicines and dietary supplements you are taking before starting this medicine as there are known drug interactions with inotuzumab ozogamicin. Also, check with your doctor or pharmacist before starting any new prescription or over-the-counter medicines, or dietary supplement to make sure that there are no interactions.

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
  • Fatigue that interferes with your daily activities
  • Feeling dizzy or lightheaded
  • Easy bleeding or bruising
  • Feeling that your heart is beating in a fast or not normal way (palpitations)
  • Blood in your urine, vomit (bright red or coffee-ground) and/or stools ( bright red, or black/tarry)
  • Coughing up blood
  • Nausea that stops you from eating or drinking and/or is not relieved by prescribed medicines
  • Throwing up more than 3 times a day
  • Signs of infusion reaction: fever or shaking chills, flushing, facial swelling, feeling dizzy, headache, trouble breathing, rash, itching, chest tightness, or chest pain.
  • Signs of possible liver problems: dark urine, pale bowel movements, bad stomach pain, feeling very tired and weak, unusual itching, or yellowing of the eyes or skin
  • Pain in your abdomen that does not go away
  • 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 8 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 5 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: Women should not breast feed during treatment and for 2 months 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.

New August 2017