Inotuzumab ozogamicin is a monoclonal antibody linked to a chemotherapy drug. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

Inotuzumab ozogamicin is used to treat a certain type of acute lymphocytic leukemia that has come back or has not responded after prior chemotherapy.

Inotuzumab ozogamicin may also be used for purposes not listed in this medication guide.

inotuzumab ozogamicin may cause serious or life-threatening liver problems, including veno-occlusive disease (blocked blood vessels in the liver that can lead to liver damage).

Call your doctor at once if you have signs of liver problems, such as upper stomach pain, jaundice (yellowing of the skin or eyes), rapid weight gain, or painful swelling in your midsection.

Inotuzumab ozogamicin is given as an infusion into a vein. A healthcare provider will give you this injection.

You may be given other medicines to help prevent certain side effects of inotuzumab ozogamicin. Take these medicines for the full prescribed length of time.

Inotuzumab ozogamicin is given in a 21-day or 28-day treatment cycle. You may need to use the medicine only on certain days of each cycle. Your doctor will determine how long to treat you with inotuzumab ozogamicin.

Inotuzumab ozogamicin may cause serious or life-threatening liver problems, including veno-occlusive disease (blocked blood vessels in the liver that can lead to liver damage). Your liver function will need to be checked.

Inotuzumab ozogamicin can also weaken (suppress) your immune system, and you may get an infection or bleed more easily. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results.

Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Tell your doctor if you have ever had:

• liver problems;

• a stem cell transplant;

• long QT syndrome (in you or a family member); or

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

You may need to have a negative pregnancy test before starting this treatment.

Inotuzumab ozogamicin can harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine, whether you are a man or a woman. Men should use condoms. Inotuzumab ozogamicin use by either parent may cause birth defects.

If you are a woman, keep using birth control for at least 8 months after your last dose of inotuzumab ozogamicin. If you are a man, keep using condoms for at least 5 months after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using inotuzumab ozogamicin.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because inotuzumab ozogamicin may harm the baby if a pregnancy does occur.

You should not breastfeed while using this medicine and for at least 2 months after your last dose.

Call your doctor for instructions if you miss an appointment for your inotuzumab ozogamicin injection.

Since inotuzumab ozogamicin is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during or shortly after the injection. Tell your caregiver right away if you feel cold, itchy, feverish, or short of breath. These symptoms could also occur up to 1 hour after your inotuzumab ozogamicin injection.

Inotuzumab ozogamicin may cause serious side effects. Call your doctor at once if you have:

• fever, weakness, cold or flu symptoms;

• cough, trouble breathing;

• swollen gums, mouth sores;

• pale skin, easy bruising, skin sores;

• a headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

• signs of liver problems--upper stomach pain, jaundice (yellowing of the skin or eyes), or rapid weight gain, swelling in your arms or legs, painful swelling in your midsection; or

• unusual bleeding--bleeding gums, abnormal vaginal bleeding, blood in your urine or stools, coughing up blood or vomit that looks like coffee grounds.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of inotuzumab ozogamicin may include:

• fever;

• feeling tired;

• nausea, stomach pain;

• headache; or

• abnormal laboratory tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Inotuzumab ozogamicin can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Other drugs may affect inotuzumab ozogamicin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.