Generic Name: inotuzumab ozogamicin (IN oh TOOZ ue mab OH zoe ga MYE sin)
Brand Name: Besponsa
What is inotuzumab ozogamicin?
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.
This medicine 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 can also weaken (suppress) your immune system, and you may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, weakness, cold or flu symptoms, mouth sores, skin sores, cough, trouble breathing).
Before taking this medicine
You should not be treated with inotuzumab ozogamicin if you are allergic to it.
To make sure inotuzumab ozogamicin is safe for you, tell your doctor if you have ever had:
a personal or family history of long QT syndrome; 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.
It is not known whether inotuzumab ozogamicin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine and for at least 2 months after your last dose.
How is inotuzumab ozogamicin given?
Inotuzumab ozogamicin is injected into a vein through an IV. 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 this medicine.
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). You will need frequent blood tests to check your liver function.
Inotuzumab ozogamicin can also lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.
Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your inotuzumab ozogamicin injection.
What happens if I overdose?
Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid while receiving inotuzumab ozogamicin?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Inotuzumab ozogamicin side effects
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.
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 may include:
nausea, stomach pain;
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 dosing information
Usual Adult Dose for Acute Lymphoblastic Leukemia:
Cycle 1 (total dose is 1.8 mg/m2/cycle):
-Day 1: 0.8 mg/m2 IV
-Day 8: 0.5 mg/m2 IV
-Day 15: 0.5 mg/m2 IV
Duration of therapy: Cycle 1 is 21 days in duration, but may be extended to 28 days (7-day therapy free interval starting on Day 21) if the patient achieves a complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), and/or to allow for recovery from toxicity
For patients who achieve a CR or CRi (total dose is 1.5 mg/m2/cycle):
-Day 1: 0.5 mg/m2 IV
-Day 8: 0.5 mg/m2 IV
-Day 15: 0.5 mg/m2 IV
Duration of therapy: 28 days (7-day therapy free interval starting on Day 21)
For patients who do not achieve a CR or CRi (total dose is 1.8 mg/m2/cycle):
-Day 1: 0.8 mg/m2 IV
-Day 8: 0.5 mg/m2 IV
-Day 15: 0.5 mg/m2 IV
Duration of therapy: 28 days (7-day therapy free interval starting on Day 21); patients who do not achieve a CR or CRi within 3 cycles should discontinue therapy
For patients proceeding to hematopoietic stem cell transplant (HSCT):
-Duration of therapy: 2 cycles; a third cycle may be considered for those patients who do not achieve CR or CRi and minimal residual disease (MRD) negativity after 2 cycles
For patients not proceeding to HSCT:
-Duration of therapy: Additional cycles of treatment, up to a maximum of 6 cycles, may be administered
-Premedicate patients with a corticosteroid, an antipyretic, and an antihistamine prior to dosing.
-Infuse for 1 hour at a rate of 50 mL/hr.
-Doses on days 8 and 15 may be varied by plus or minus 2 days (maintain a minimum of 6 days between doses).
-Complete remission (CR) is defined as less than 5% blasts in bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts [platelets 100 x 10(9)/L or greater and absolute neutrophil count (ANC) 1 x 10(9)/L or greater] and resolution of any extramedullary disease.
-Complete remission with incomplete hematologic recovery (CRi) is defined as less than 5% blasts in bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts [platelets less than 100 x 10(9)/L and ANC less than 1 x 10(9)/L] and resolution of any extramedullary disease.
-For patients with circulating lymphoblasts, cytoreduction with a combination of hydroxyurea, steroids, and/or vincristine to a peripheral blast count of 10,000/mm3 or less is recommended prior to the first dose.
-Observe patients for infusion reactions during and for at least 1 hour after the end of the infusion.
What other drugs will affect inotuzumab ozogamicin?
Inotuzumab ozogamicin can cause a serious heart problem, especially if you use certain medicines at the same time, such as antibiotics, antifungal medicine, antidepressants, anti-malaria medicine, asthma inhalers, antipsychotic medicine, cancer medicine, certain HIV/AIDS medicine, heart or blood pressure medicine, or medicine to prevent vomiting. Tell your doctor about all your current medicines and any medicine you start or stop using.
Other drugs may interact with 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.
More about inotuzumab ozogamicin
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- Support Group
- En Español
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- Drug class: miscellaneous antineoplastics
Other brands: Besponsa
Related treatment guides
Where can I get more information?
- Your pharmacist can provide more information about inotuzumab ozogamicin.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
- Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2012 Cerner Multum, Inc. Version: 1.01.
Date modified: January 03, 2018
Last reviewed: September 05, 2017