Description
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.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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
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
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
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.
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