Moxetumomab pasudotox-tdfk (Intravenous)

Moxetumomab pasudotox-tdfk injection is used to treat hairy cell leukemia that has gotten worse or cannot be fully removed in patients who have had at least two previous treatments that did not work well.

This medicine is to be given only by your doctor or under their direct supervision.

It is very important that your doctor check your progress while you are receiving this medicine to ensure it is working properly. Blood and urine tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy during treatment with this medicine and for at least 30 days after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

This medicine may cause a condition called capillary leak syndrome. It can lead to fluid leaking from the blood vessels into your body's tissues. Call your doctor right away if you have swelling or puffiness and are urinating less often, have trouble breathing, feel a sense of fullness, experience dizziness, or feel faint.

This medicine may cause kidney problems, including hemolytic uremic syndrome and kidney failure. Check with your doctor right away if you have stomach pain, blood in the urine, fever, increased or decreased urination, pinpoint red spots on the skin, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual tiredness or weakness, or yellow eyes or skin.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness, or fainting after receiving this medicine.

In deciding to use a medicine, you and your doctor will weigh the risks against the benefits of the medicine. Here are some important points to consider:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your health care professional about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to understand how moxetumomab pasudotox-tdfk injection affects children. Its safety and effectiveness have not been established for the pediatric population.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of moxetumomab pasudotox-tdfk injection. However, older patients are more likely to have kidney issues related to aging, which may require caution when using this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine during breastfeeding. Consider the potential benefits and risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together despite a possible interaction. In these situations, your doctor may want to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at the same time as food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine is used. Be sure to tell your doctor if you have any other medical problems, especially:

• Blood and blood vessel problems or
• Hemolytic uremic syndrome, history of or
• Kidney disease or
• Thrombotic microangiopathy, severe, history of—Use with caution. This may worsen these conditions.

• Electrolyte or fluid imbalance—Use with caution. This must be corrected before receiving this medicine.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Back pain
• black, tarry stools
• blood in the urine
• blurred vision
• bone pain
• chest pain or tightness
• chills
• confusion
• cough
• dizziness
• drowsiness
• dry mouth
• fast or irregular heartbeat
• feeling of warmth
• fever
• headache
• increased or decreased urination
• increased thirst
• joint pain, stiffness, or swelling
• loss of appetite
• loss of consciousness
• lower back, side, or stomach pain
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• muscle pain
• muscle spasms (tetany) or twitching seizures
• nausea
• nervousness
• numbness and tingling around the mouth, fingertips, or feet
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• pounding in the ears
• redness of the face, neck, arms, and sometimes, upper chest
• seizures
• slow or fast heartbeat
• sore throat
• stomach cramps or pain
• swelling of the face, fingers, feet, lower legs, or ankles
• trembling
• tremor
• troubled breathing
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin

Less common

• Chest discomfort
• stomach bloating

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome, or if you have any questions about them:

More common

• Constipation
• diarrhea
• dry eye

Less common

• Blindness
• bloody eye
• burning, dry, or itching eyes
• decreased vision
• discharge, excessive tearing
• discomfort, pain, or swelling of the eye or around the eye
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Lumoxiti

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Moxetumomab Pasudotox

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. The medicine must be given slowly, so the needle will have to stay in place for at least 30 minutes.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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.

• What type of drug is Lumoxiti?