Moxetumomab Pasudotox-tdfk (mox-e-TOOM-oh-mab pa-SOO-doe-tox - tdfk)

Treats hairy cell leukemia.

Brand Name(s):

Lumoxiti

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. The medicine must be given slowly, so the needle will have to stay in place for at least 30 minutes.
• A nurse or other health provider will give you this medicine.
• Your doctor will give you other medicines (including allergy medicine, fever medicine, stomach or ulcer medicine) 30 to 90 minutes before each treatment to prevent unwanted effects, and for up to 24 hours after your infusion. An oral steroid medicine may be given to decrease nausea and vomiting.
• Your doctor will give you a saline solution for at least 2 to 4 hours before and after each infusion to keep you hydrated. You should also drink up to 3 liters (eight to twelve 8-oz glasses) of liquids (including water, milk, or juice) per 24 hours on days 1 through 8 of each 28-day cycle.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control during treatment with this medicine and for at least 30 days after the last dose.
• Do not breastfeed during treatment with this medicine.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Tell your doctor if you have kidney disease, blood and blood vessel problems, or electrolyte or fluid imbalance.
• This medicine may cause the following problems:
  • Capillary leak syndrome
  • Hemolytic uremic syndrome
  • Kidney problems
  • Infusion reaction
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark urine, decrease in how much or how often you urinate
• Lightheadedness, dizziness, fainting
• Muscle cramping, irregular or fast heartbeat, seizures, numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Nausea, vomiting, severe itching, bleeding from your gums or nose
• Pain, redness, or swelling where the needle is placed
• Pinpoint red or purple spots under your skin
• Swelling in your face, ankles, or feet
• Troubled or fast breathing, cough

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea
• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088