WARNING

Besponsa (inotuzumab ozogamicin) is a medication used to treat certain types of leukemia. Like any medication, it comes with potential risks and side effects. Here are some key risks associated with taking Besponsa:

• Liver toxicity: Besponsa can cause liver damage, which may be severe in some cases. Monitoring liver function is crucial during treatment.
• Infusion reactions: Some people may experience allergic reactions or infusion-related reactions during or shortly after receiving Besponsa. These can range from mild to severe and may require medical intervention.
• Increased risk of infections: Besponsa can suppress the immune system, increasing the risk of infections. Patients should be monitored for signs of infection and may need treatment with antibiotics or other medications.
• Bleeding: Besponsa can affect blood clotting, leading to an increased risk of bleeding. This risk may be higher in patients with pre-existing bleeding disorders or those taking blood-thinning medications.
• Tumor lysis syndrome: In some cases, Besponsa may cause tumor lysis syndrome, a condition where cancer cells break down rapidly, releasing toxins into the bloodstream. This can lead to serious complications such as kidney failure and abnormal heart rhythms.
• Other side effects: Other common side effects of Besponsa include nausea, fever, fatigue, headache, and low blood cell counts.

It’s essential for patients to discuss the potential risks and benefits of Besponsa with their healthcare provider before starting treatment and to report any unusual symptoms or side effects promptly.

Why is this medication prescribed?

Besponsa is prescribed primarily for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This type of leukemia is a rapidly progressing cancer of the blood and bone marrow characterized by the overproduction of immature white blood cells called lymphoblasts.

When ALL relapses (returns) after initial treatment or becomes refractory (fails to respond) to standard therapies, Besponsa may be considered as a treatment option. It works by targeting and killing cancerous B-cells, helping to suppress the progression of the disease.

How should this medicine be used?

Besponsa (inotuzumab ozogamicin) is typically administered intravenously (IV) by a healthcare professional. The dosage and schedule for Besponsa may vary based on individual patient factors, such as weight, overall health condition, and response to treatment. Here’s a general overview of how Besponsa is typically used:

• Administration: Besponsa is administered as an intravenous infusion over a period of time. The infusion is given through a vein, usually in the arm.
• Dosage: The recommended dosage of Besponsa can vary depending on factors such as body weight and overall health. Your healthcare provider will determine the appropriate dosage for you.
• Treatment cycles: Besponsa treatment usually consists of multiple cycles. Each treatment cycle may include several doses of the medication given over a specified period.
• Monitoring: Your healthcare provider will closely monitor your response to Besponsa treatment. This may involve regular blood tests and other assessments to evaluate the effectiveness of the medication and monitor for any potential side effects.
• Follow-up: It’s essential to follow your healthcare provider’s instructions precisely when using Besponsa. Attend all scheduled appointments and follow any additional recommendations provided by your healthcare team.
• Storage: Besponsa should be stored according to the manufacturer’s instructions, typically at controlled room temperature. Be sure to store the medication safely out of reach of children and pets.

It’s crucial to communicate openly with your healthcare provider about any questions or concerns you have about Besponsa, including its use, dosage, and potential side effects. They can provide personalized guidance based on your individual needs and circumstances.

Other uses for this medicine

Besponsa (inotuzumab ozogamicin) is primarily used for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults. However, there may be other off-label uses of Besponsa, meaning it could be prescribed by healthcare providers for conditions not specifically approved by regulatory agencies like the FDA. Off-label use may occur based on clinical judgment and evidence supporting the medication’s efficacy and safety for certain conditions.

What special precautions should I follow?

Some special precautions to consider when using Besponsa include:

• Pregnancy and breastfeeding: Besponsa can cause harm to a developing fetus, so it’s essential to avoid becoming pregnant while receiving treatment and for a period afterward. Additionally, it’s not recommended to breastfeed during treatment with Besponsa.
• Liver function: Besponsa can affect liver function, so your healthcare provider may monitor your liver function through blood tests before and during treatment. Depending on the results, adjustments to the dosage or frequency of administration may be necessary.
• Infusion reactions: Like many intravenous medications, Besponsa may cause infusion-related reactions, such as fever, chills, or allergic reactions. Your healthcare provider will monitor you closely during and after the infusion and may administer medications to manage any reactions that occur.
• Bone marrow suppression: Besponsa can suppress bone marrow function, leading to decreased production of blood cells. Your healthcare provider will monitor your blood counts regularly and may adjust your treatment regimen as needed.
• Infections: Patients receiving Besponsa may be at an increased risk of developing infections due to decreased immune function. It’s important to take precautions to avoid infections and promptly report any signs or symptoms of infection to your healthcare provider.
• Other medications: Inform your healthcare provider about all medications, supplements, and herbal products you are taking, as they may interact with Besponsa and affect its effectiveness or increase the risk of side effects.
• Medical history: Your healthcare provider should be aware of your medical history, including any pre-existing conditions such as liver disease or previous allergic reactions, as these may affect the safety and suitability of Besponsa treatment for you.

It’s crucial to discuss any questions or concerns you have about Besponsa and its potential side effects with your healthcare provider. They can provide personalized guidance and monitoring throughout your treatment journey.

What special dietary instructions should I follow?

Regarding special dietary instructions, there are no specific dietary restrictions associated with Besponsa. However, it’s essential to maintain a balanced and nutritious diet to support overall health and well-being during treatment.

What should I do if I forget a dose?

If you forget a dose of Besponsa, contact your healthcare provider or treatment team as soon as possible for guidance. They can advise you on the best course of action, which may involve rescheduling the missed dose or adjusting your treatment plan as necessary. It’s important not to double the dose to make up for a missed one unless instructed to do so by your healthcare provider.

What side effects can this medication cause?

Besponsa (inotuzumab ozogamicin) can cause various side effects, ranging from mild to severe. It’s essential to be aware of these potential side effects and to promptly inform your healthcare provider if you experience any concerning symptoms. Common side effects of Besponsa may include:

• Infusion-related reactions: These may include fever, chills, flushing, rash, itching, or shortness of breath during or shortly after the infusion. Your healthcare provider will monitor you closely during treatment and may administer medications to manage these reactions.
• Low blood cell counts: Besponsa can suppress bone marrow function, leading to decreased production of blood cells. This may result in an increased risk of anemia (low red blood cell count), neutropenia (low white blood cell count), or thrombocytopenia (low platelet count), which can cause symptoms such as fatigue, weakness, increased susceptibility to infections, and easy bruising or bleeding.
• Infections: Besponsa treatment may increase the risk of infections due to decreased immune function. Inform your healthcare provider if you develop signs or symptoms of infection, such as fever, chills, cough, sore throat, or difficulty breathing.
• Liver problems: Besponsa can affect liver function, leading to elevated liver enzymes or liver damage. Your healthcare provider will monitor your liver function through blood tests and may adjust your treatment regimen if necessary.
• Nausea, vomiting, diarrhea: These gastrointestinal symptoms may occur as side effects of Besponsa treatment. Your healthcare provider may prescribe medications to help manage these symptoms.
• Fatigue: Feeling tired or weak is a common side effect of Besponsa treatment.
• Headache: Some individuals may experience headaches while receiving Besponsa.
• Abdominal pain: Pain or discomfort in the abdominal area may occur as a side effect of Besponsa.

These are not all the possible side effects of Besponsa. Other side effects may occur. If you experience any new or worsening symptoms while receiving Besponsa, contact your healthcare provider promptly for further evaluation and guidance. They can provide recommendations for managing side effects and adjust your treatment plan if necessary.

What should I know about storage and disposal of this medication?

Storage and disposal of Besponsa:

• Storage: Besponsa should be stored according to the manufacturer’s instructions, typically at controlled room temperature away from light and moisture. Be sure to keep it out of reach of children and pets.
• Disposal: Unused or expired Besponsa should be disposed of properly according to local regulations. Do not dispose of medications in household trash or flush them down the toilet unless instructed to do so. Instead, consult with your healthcare provider or pharmacist for guidance on safe disposal options.

In case of emergency/overdose

• Seek medical attention: If you believe you or someone else may have overdosed on Besponsa or experienced a severe reaction, seek immediate medical assistance by calling emergency services or going to the nearest emergency room.
• Symptom management: Depending on the nature and severity of the overdose or reaction, medical professionals will provide appropriate treatment to manage symptoms and stabilize the individual’s condition.

What other information should I know?

• Follow-up appointments: Attend all scheduled follow-up appointments with your healthcare provider to monitor your response to Besponsa treatment and to address any concerns or questions you may have.
• Medication adherence: It’s crucial to follow your healthcare provider’s instructions precisely when using Besponsa, including the dosage, schedule, and administration method. Do not adjust your dosage or stop taking Besponsa without consulting your healthcare provider first.
• Inform healthcare providers: Make sure to inform all healthcare providers involved in your care, including doctors, nurses, and pharmacists, that you are receiving Besponsa treatment. This helps ensure coordinated care and reduces the risk of potential interactions with other medications or treatments.
• Patient support resources: Consider utilizing patient support resources provided by the manufacturer or healthcare institutions, which may offer additional information, assistance, or resources related to Besponsa treatment.
• Adverse reactions: Be vigilant for any adverse reactions or side effects while receiving Besponsa treatment, and promptly report them to your healthcare provider. They can provide guidance on managing side effects and adjusting your treatment plan if necessary.

By adhering to proper storage and disposal practices, being aware of emergency procedures, and staying informed about Besponsa treatment, you can help ensure safe and effective use of the medication. Always consult with your healthcare provider for personalized guidance and recommendations specific to your individual circumstances.