Treatment Name: Inotuzumab Ozogamicin (Besponsa®)
Inotuzumab Ozogamicin (Besponsa®) is a Treatment Regimen for Acute Lymphoid Leukemia (ALL)
How does Inotuzumab Ozogamicin (Besponsa®) work?
Inotuzumab ozogamicin is an antibody that targets leukemia cells. Once it binds to the leukemia cell surface, it then enters the inside of the cancer cell. Once inside the cell, the antibody releases a drug called calicheamicin, which damages the DNA of the leukemia cell and causes the cell to die.
Goals of therapy:
Inotuzumab ozogamicin is given to kill leukemia cells and restore normal bone marrow activity. It is given with the goal of achieving disease remission, and possibly a cure, in patients who have relapsed or who are refractory after at least one prior treatment for ALL. If remission is achieved, some patients may receive a bone marrow transplant with the goal of cure.
- Inotuzumab ozogamicin intravenous (I.V.) infusion over 60 minutes on Days 1, 8, and 15
Estimated total infusion time for this treatment:
- Up to 2 hours for Days 1, 8, and 15 of each cycle (one hour infusion followed by one hour observation period)
- Infusion times are based on clinical studies, but may vary depending on doctor preference or patient tolerability. Pre-medications and intravenous (I.V.) fluids, such as hydration, may add more time
Inotuzumab ozogamicin is usually given in an outpatient infusion center, allowing the person to go home afterwards. On occasion, it may be given in the hospital if someone is too sick.
The first cycle of inotuzumab ozogamicin is given over 21 days. All subsequent cycles are given every 28 days. If complete remission is not achieved after three cycles of therapy, inotuzumab ozogamicin is typically stopped.
For patients in remission that are proceeding to bone marrow transplant, inotuzumab ozogamicin may be given for up to three cycles. For patients in remission who are not proceeding to bone marrow transplant, inotuzumab ozogamicin may be given for up to six cycles. Duration of therapy may last up to six months, depending upon response, tolerability, and number of cycles prescribed.
Click here for the common inotuzumab ozogamicin (Besponsa®) starting doses.
In clinical studies, the most commonly reported side effects of inotuzumab ozogamicin are shown here:
- Low white blood cells [neutropenia] (48%)
- Low platelets [thrombocytopenia] (45%)
- Nausea (32%)
- Low red blood cells [anemia] (30%)
- Headache (28%)
- Neutropenic fever (27%)
- Fever (27%)
- Fatigue (22%)
- Diarrhea (18%)
- Vomiting (17%)
- Constipation (17%)
- Nose bleed (15%)
- Trouble sleeping (15%)
- Stomach pain (14%)
- Cough (11%)
- Severe liver injury [veno-occlusive disease] (11%)
- Chills (10%)
- Decreased appetite (9%)
- Rash (9%)
- Pain in arms or legs (9%)
- Dizziness (9%)
- Weakness (9%)
- Fluid accumulation in arms or legs (9%)
- Low blood pressure (8%)
- Shortness of breath (5%)
On average, 15% of patients discontinue treatment due to unacceptable side effects.
How often is monitoring needed?
Labs (blood tests) may be checked before each treatment or more often if needed. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), uric acid, phosphorous, lactate dehydrogenase (LDH), plus any others your doctor may order.
How often is imaging needed?
Imaging may be checked if there are concerns for infection, a blood clot, or bleeding. Imaging may include: X-rays, computerized tomography (CT) scans, or magnetic resonance imaging (MRI). Electrocardiograms, commonly referred to as an ECG or EKG, are used to evaluate the QTc interval prior to therapy and periodically throughout treatment.
How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue inotuzumab ozogamicin (Besponsa®) as planned, reduce the dose of future treatments, delay the next dose until the side effect goes away, or switch to an alternative therapy.
- Inotuzumab ozogamicin can cause a serious liver condition known as veno-occlusive disease (VOD). VOD is more common in patients who receive a bone marrow transplant after receiving therapy with inotuzumab ozogamicin, but it may also occur in patients who don’t receive a transplant. Other risk factors include prior liver disease, increased age, number of prior chemotherapy treatments, and the number inotuzumab ozogamicin treatments given. Contact your doctor immediately if you notice yellowing of the eyes or skin and severe stomach pain or swelling. In some cases, VOD can be treated with a drug called defibrotide (Defitelio®)
- Due to the risk of delayed infusion reactions, you may need to be observed in the infusion center for one hour after each inotuzumab ozogamicin infusion is complete
- If your blood has a high number of leukemia cells (> 10,000 cells/mm), you may need to receive medications to lower the amount of leukemia cells before inotuzumab ozogamicin can be started. These medications may include hydroxyurea (Hydrea®), vincristine (Oncovin®), or a corticosteroid such as dexamethasone (Decadron®)
- Premedications such as diphenhydramine (Benadryl®), acetaminophen (Tylenol®), and hydrocortisone (Solu-Cortef®) may be given before rituximab to help avoid infusion related reactions. You may need to be watched for a reaction for at least one hour after the infusion is complete
- A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
- Clinical trials may exist for ALL. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications
Patient Assistance & Co-payment Coverage
Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Inotuzumab Ozogamicin (Besponsa®), we have provided links that may help.
Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Inotuzumab Ozogamicin (Besponsa®). Depending upon your income, they may be able to help cover the cost of:
For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.
- If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.
Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Inotuzumab Ozogamicin (Besponsa®) and are the best source to help you understand drug cost.
- Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.
What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.
Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.
Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.
Learn more about pursuing emotional wellness while receiving treatment with Inotuzumab Ozogamicin (Besponsa®)