Trade Name: BESPONSA™
Generic Name: inotuzumab ozogamicin
For which conditions is BESPONSA™ approved? BESPONSA is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The labeling contains a boxed warning to alert healthcare professionals and patients about potential severe and or life-threatening side effect of severe liver damage that includes blockage of veins in the liver. The boxed warning also includes an increased risk of death for patients who take Besponsa after receiving a certain type of stem cell transplant.
What is the mechanism of action of BESPONSA™? BESPONSA is a a targeted therapy that consists of an antibody connected to an anti-tumor agent that is toxic to cells. It is thought to work by taking the anti-tumor agent to the CLL cells that express the CD33 antigen, blocking the growth of cancerous cells and causing cell death.
How is BESPONSA typically given (administered)? BESPONSA is administered intravenously following premedication with antihistamines, corticosteroid, and medication to prevent or reduce fever. The schedule and dose of BESPONSA depends on cycle and response to treatment.
How are patients typically monitored? Before taking BESPONSA, discuss any medical conditions with your healthcare provider. Patients are monitored for infusion-related reactions during and for at least 1 hour after the infusion is complete. Electrocardiograms and electrolytes are also typically monitored during treatment with BESPONSA. In addition, blood will be drawn before and after treatment to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans, or other measures to assess side effects and response to therapy.
BESPONSA can harm an unborn baby, so women and partners of men on BESPONSA should not become pregnant during treatment. Women are advised to avoid pregnancy for at least 8 month following their last dose of BESPONSA and men are advised to avoid reproduction for at least 5 months following treatment. Do not breastfeed during treatment with BESPONSA and for at least 2 months after your last treatment.
What are the most common (occur in 20% or more of patients) side effects of treatment with BESPONSA?
- Low levels of platelets (thrombocytopenia)
- Low levels of white blood cells (neutropenia, leukopenia)
- Low levels of red blood cells (anemia)
- Severe bleeding
- Low levels of white blood cells with fever (febrile neutropenia)
- Liver damage
- Abdominal pain
- High levels of bilirubin in the blood
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects of BESPONSA™?
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how BESPONSA works and can cause side effects. BESPONSA may cause severe or life-threatening side effects and it is important that you call your healthcare provider or get emergency help right away if you experience symptoms of veno-occlusive disease which include elevated bilirubin, rapid weight gain, or abdominal swelling that may be painful. Talk to your doctor about risks of treatment with BESPONSA after a hematopoietic stem cell transplant.
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Are there any special precautions patients should be aware of before starting treatment?
Talk to your healthcare provider about any medicines (prescription and over-the-counter), vitamins or herbal supplements that you are taking. BESPONSA can affect your ability to drive and use machines, avoid operating heavy or potentially dangerous machinery for at least 8 weeks following treatment with BESPONSA. Talk to your doctor about the risk of manufacturing failure of BESPONSA. You should plan to stay within 2 hours of the location where you received your treatment for at least 4 weeks after treatment with BESPONSA.
When should patients notify their physician?
Tell your doctor if you experience any side effects that bother you or don’t go away. BESPONSA may cause severe or life-threatening side effects and it is important that you call your healthcare provider or get emergency help right away if you experience symptoms of veno-occlusive disease which include elevated bilirubin, rapid weight gain, or abdominal swelling that may be painful. Talk to your doctor about risks of treatment with BESPONSA after a hematopoietic stem cell transplant. Also, report signs and symptoms of infection, bleeding, or other effects of decreased blood counts as well as signs ofa heart rhythm condition (QT interval prolongation) which include dizziness, lightheadedness, or loss of consciousness.
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
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