Moxetumomab Pasudotox-tdfk (Lumoxiti™)

How to Take Moxetumomab Pasudotox-tdfk (Lumoxiti™)

Moxetumomabpasudotox-tdfk is given by intravenous (IV, into a vein) infusion. The dosage is based on your size and how often you receive the medication will depend on how well you tolerate it. It is very important to maintain proper hydration before, during and after the infusion. You will be instructed regarding how much fluid you should take in by mouth on certain days of your chemotherapy regimen cycle. You will also be given intravenous fluids before and after the infusion.

You may be instructed to take low dose aspirin on certain days to prevent a blood clot. To prevent a reaction to the medication you will be given acetaminophen, an antihistamine (such as Benadryl), and an H2 receptor antagonist (such as Zantac). You may also be given medications after the infusion to continue to prevent a reaction and to lessen any nausea and vomiting. You will also have your labs checked prior to receiving the medication, and throughout your treatment course to monitor your electrolyte values.

Possible Side Effects

There are a number of things you can do to manage the side effects of moxetumomab pasudotox-tdfk. Talk to your care team about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:

Capillary Leak Syndrome

Capillary leak syndrome is a condition in which blood, and components of blood, leak out of vessels and into body cavities and muscles. The movement of this fluid out of the vessels can cause hypotension (low blood pressure) and organ failure. Signs and symptoms of capillary leak syndrome include: a sudden drop in blood pressure, weakness, fatigue, sudden swelling of the arms, legs or other parts of the body, nausea, cough, shortness of breath and lightheadedness. If you are having any of these symptoms notify your healthcare provider immediately.

Hemolytic Uremic Syndrome

This medication can cause a rare syndrome called hemolytic uremic syndrome (HUS) that destroys red blood cells, damages blood vessels, and can lead to kidney failure. Your healthcare team will monitor you for symptoms of HUS throughout your treatment. Notify your healthcare team if you have unusual bruising or bleeding or notice a decrease in urine output.

Infusion-Related Side Effects

The infusion can cause a reaction that may lead to chills, cough, dizziness, dyspnea, feeling hot, flushing, headache, hypertension, hypotension, infusion related reaction, myalgia, nausea, pyrexia, sinus tachycardia, tachycardia, vomiting, or wheezing. You will receive medications prior to the infusion to help prevent these reactions. You should notify your provider immediately of any changes you are experiencing while receiving this medication.

Electrolyte Abnormalities

This medication can affect the normal levels of electrolytes (calcium, phosphate, etc.) in your body. Your levels will be monitored using blood tests. If your levels become too low, your care team may prescribe specific electrolytes to be given by IV or taken by mouth. Do not take any supplements without first consulting with your care team.

Low Red Blood Cell Count (Anemia)

Your red blood cells are responsible for carrying oxygen to the tissues in your body. When the red cell count is low, you may feel tired or weak. You should let your oncology care team know if you experience any shortness of breath, difficulty breathing or pain in your chest. If the count gets too low, you may receive a blood transfusion.

Low White Blood Cell Count (Leukopenia or Neutropenia)

White blood cells (WBC) are important for fighting infection. While receiving treatment, your WBC count can drop, putting you at a higher risk of getting an infection. You should let your doctor or nurse know right away if you have a fever (temperature greater than 100.4°F/38°C), sore throat or cold, shortness of breath, cough, burning with urination, or a sore that doesn't heal.

Tips to preventing infection:

• Washing hands, both yours and your visitors, is the best way to prevent the spread of infection.
• Avoid large crowds and people who are sick (i.e.: those who have a cold, fever or cough or live with someone with these symptoms).
• When working in your yard, wear protective clothing including long pants and gloves.
• Do not handle pet waste.
• Keep all cuts or scratches clean.
• Shower or bath daily and perform frequent mouth care.
• Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
• Ask your oncology care team before scheduling dental appointments or procedures.
• Ask your oncology care team before you, or someone you live with, has any vaccinations.

Kidney Problems

This medication can cause kidney problems, including an increased creatinine level, which your oncology care team may monitor for using blood tests. Notify your healthcare provider if you notice decreased urine output, blood in the urine, swelling in the ankles, or loss of appetite.

Liver Toxicity

This medication can cause liver toxicity, which your oncology care team may monitor for using blood tests called liver function tests. Notify your healthcare provider if you notice yellowing of the skin or eyes, your urine appears dark or brown, or you have pain in your abdomen, as these can be signs of liver toxicity.

Edema

Edema is swelling of the extremities caused by retention of fluid. It can cause swelling of the hands, arms, legs, ankles and feet. The swelling can become uncomfortable. Notify your oncology care team right away if you are experiencing any new, sudden or worsening swelling.

Nausea and/or Vomiting

Talk to your oncology care team so they can prescribe medications to help you manage nausea and vomiting. In addition, dietary changes may help. Avoid things that may worsen the symptoms, such as heavy or greasy/fatty, spicy or acidic foods (lemons, tomatoes, oranges). Try saltines, or ginger ale to lessen symptoms.

Call your oncology care team if you are unable to keep fluids down for more than 12 hours or if you feel lightheaded or dizzy at any time.

Fatigue

Fatigue is very common during cancer treatment and is an overwhelming feeling of exhaustion that is not usually relieved by rest. While on cancer treatment, and for a period after, you may need to adjust your schedule to manage fatigue. Plan times to rest during the day and conserve energy for more important activities. Exercise can help combat fatigue; a simple daily walk with a friend can help. Talk to your healthcare team for helpful tips on dealing with this side effect.

Headache

Your healthcare provider can recommend medications and other strategies to help relieve pain.

Constipation

There are several things you can do to prevent or relieve constipation. Include fiber in your diet (fruits and vegetables), drink 8-10 glasses of non-alcoholic fluids a day, and keep active. A stool softener once or twice a day may prevent constipation. If you do not have a bowel movement for 2-3 days, you should contact your healthcare team for suggestions to relieve the constipation.

Low Platelet Count (Thrombocytopenia)

Platelets help your blood clot, so when the count is low you are at a higher risk of bleeding. Let your oncology care team know if you have any excess bruising or bleeding, including nose bleeds, bleeding gums or blood in your urine or stool. If the platelet count becomes too low, you may receive a transfusion of platelets.

• Do not use a razor (an electric razor is fine).
• Avoid contact sports and activities that can result in injury or bleeding.
• Do not take aspirin (salicylic acid), non-steroidal, anti-inflammatory medications (NSAIDs) such as Motrin/Advil (ibuprofen), Aleve (naproxen), Celebrex (celecoxib) etc. as these can all increase the risk of bleeding. Please consult with your healthcare team regarding use of these agents and all over the counter medications/supplements while on therapy.
• Do not floss or use toothpicks and use a soft-bristle toothbrush to brush your teeth.

Diarrhea

Your oncology care team can recommend medications to relieve diarrhea. Also, try eating low-fiber, bland foods, such as white rice and boiled or baked chicken. Avoid raw fruits, vegetables, whole grain breads, cereals and seeds. Soluble fiber is found in some foods and absorbs fluid, which can help relieve diarrhea. Foods high in soluble fiber include: applesauce, bananas (ripe), canned fruit, orange sections, boiled potatoes, white rice, products made with white flour, oatmeal, cream of rice, cream of wheat, and farina. Drink 8-10 glasses of non-alcoholic, un-caffeinated fluid a day to prevent dehydration.

Reproductive Concerns

Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. Effective birth control is necessary during treatment and for at least 30 days after treatment. Even if your menstrual cycle stops or you believe you are not producing sperm, you could still be fertile and conceive. You should not breastfeed while receiving this medication.