Inotuzumab ozogamicin

Inotuzumab ozogamicin is a monoclonal antibody connected to a chemotherapy drug. Monoclonal antibodies are designed to target and kill specific cells in the body, which may help to spare healthy cells from harm.

Inotuzumab ozogamicin is used to treat a specific type of acute lymphocytic leukemia that has returned or has not responded to previous chemotherapy.

Inotuzumab ozogamicin may also be used for reasons not mentioned 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 right away if you notice signs of liver problems, such as pain in the upper stomach, jaundice (yellowing of the skin or eyes), rapid weight gain, or painful swelling in your abdomen.

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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty 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 happen up to 1 hour after your inotuzumab ozogamicin injection.

Inotuzumab ozogamicin may cause serious side effects. Call your doctor immediately 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 stopped 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 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).

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 happen.

Follow your doctor's instructions regarding any restrictions on food, drinks, or activities.

Inotuzumab ozogamicin can lead to a serious heart issue. Your risk might increase if you are also taking specific other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Other medications may interact with inotuzumab ozogamicin, including both prescription and over-the-counter drugs, vitamins, and herbal products. Inform your doctor about all the medicines you are currently taking and any new medicine you begin or stop using.