Generic Name: inotuzumab ozogamicin (IN oh TOOZ ue mab OH zoe ga MYE sin)
Brand Name: Besponsa
What is Besponsa?
Besponsa 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.
Besponsa is used to treat a certain type of acute lymphocytic leukemia that has come back or has not responded after prior chemotherapy.
Besponsa may also be used for purposes not listed in this medication guide.
Besponsa 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.
Besponsa 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 Besponsa if you are allergic to it.
To make sure Besponsa 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.
Besponsa 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. This medicine 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 Besponsa.
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 Besponsa 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 Besponsa given?
Besponsa 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.
Besponsa 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 Besponsa.
Besponsa 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.
Besponsa 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 Besponsa.
What happens if I overdose?
Since Besponsa is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid while receiving Besponsa?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Besponsa 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 Besponsa 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;
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
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.
What other drugs will affect Besponsa?
Besponsa 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.
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.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Copyright 1996-2018 Cerner Multum, Inc. Version: 1.01.
More about Besponsa (inotuzumab ozogamicin)
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- Pricing & Coupons
- En Español
- Drug class: miscellaneous antineoplastics
- FDA Approval History