Pronunciation:

mox-e-TOOM-oh-mab pa-SOO-doe-tox - tdfk

Brand Names:

• Lumoxiti

Dosage Forms:

• Powder for Solution

Warnings:

Warning: Capillary Leak Syndrome And Hemolytic Uremic SyndromeCapillary Leak Syndrome (CLS), including life-threatening cases, occurred in patients receiving moxetumomab pasudotox-tdfk. Monitor weight and blood pressure; check labs, including albumin, if CLS is suspected. Delay dosing or discontinue moxetumomab pasudotox-tdfk as recommended.Hemolytic Uremic Syndrome (HUS), including life-threatening cases, occurred in patients receiving moxetumomab pasudotox-tdfk. Monitor hemoglobin, platelet count, serum creatinine, and ensure adequate hydration. Discontinue moxetumomab pasudotox-tdfk in patients with HUS .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Moxetumomab Pasudotox

Uses of This Medicine:

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

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

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

Children—

Appropriate studies have not been performed on the relationship of age to the effects of moxetumomab pasudotox-tdfk injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of moxetumomab pasudotox-tdfk injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you 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. May make these conditions worse.

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you are receiving this medicine to make sure this medicine 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 keep from getting pregnant 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 cause fluid to leak 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, trouble breathing, feeling of fullness, dizziness, or feeling 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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately 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 occasionally, 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. Also, your health care professional may 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.