Description
Denileukin diftitox-cxdl injection is used to treat a type of skin cancer called Stage I to III cutaneous T-cell lymphoma (CTCL) that has come back (relapsed) or did not respond to treatment (refractory) in patients who have received at least one previous treatment.
Denileukin diftitox-cxdl injection is a man-made version of a substance called interleukin-2. Interleukins are produced naturally by cells in the body to help white blood cells work.
This medicine is to be given only by or under the supervision of your doctor.
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 denileukin diftitox-cxdl 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 denileukin diftitox-cxdl injection in the elderly.
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:
- Edema (swelling) or
- Hypotension (low blood pressure) or
- Kidney disease or
- Liver disease—Use with caution. May make theses conditions worse.
Proper Use
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.
A nurse or other trained health professional will give you this medicine in a medical facility. It is given through an IV catheter that is placed into one of your veins. It must be given slowly, so the IV will have to remain in place for at least 60 minutes on Days 1 to 5 of a 21-day cycle.
Your doctor may also give you extra fluids and other medicines (eg, allergy medicine, fever medicine, steroid, or medicine to prevent nausea or vomiting) 30 minutes before receiving this medicine.
Precautions
It is very important that your doctor check your progress closely and at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Receiving this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for 7 days after the last dose. If you think you have become pregnant while using 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.
Check with your doctor right away if blurred vision, difficulty with reading, eye pain, or any other change in vision occurs while you are receiving this medicine. Your doctor may want your eyes checked by an ophthalmologist (eye doctor).
This medicine may cause infusion-related reactions, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you start to have a skin rash, dizziness, trouble breathing, chest tightness, swelling in your face or hands, fever, or chills while you are receiving this medicine.
Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Some men who receive this medicine have become infertile (unable to have children). Talk with your doctor before starting treatment with this medicine if you plan to have children.
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
- Agitation
- arm or leg pain
- back pain
- being forgetful
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or cloudy urine
- blurred vision
- bone pain
- chest tightness
- chills
- coma
- confusion as to time, place, or person
- constipation
- decreased appetite
- decrease or increase in amount of urine
- defects in intelligence, short-term memory, learning ability, and attention
- depression
- diarrhea
- difficulty in moving
- dizziness
- fainting or lightheadedness
- fever
- flushing
- hallucinations
- headache, severe and throbbing
- holding false beliefs that cannot be changed by fact
- hostility
- increased blood pressure
- irritability
- itching, pain, redness, swelling on the skin
- lack or loss strength
- lethargy
- loss of appetite
- loss of memory
- lower back or side pain
- mental depression or anxiety
- muscle aches, cramps, pain, stiffness, or twitching
- nausea and vomiting
- neck pain
- nightmares or unusually vivid dreams
- problems with memory
- rapid weight gain
- red rash with watery, yellow-colored, or pus filled blisters
- seizures
- sleepiness or unusual drowsiness
- stomach pain
- swelling of the hands, ankles, feet, or lower legs
- swelling or puffiness of the face
- thick yellow to honey-colored crusts
- tingling of the hands or feet
- trouble breathing
- unusual excitement, nervousness, or restlessness
- unusual tiredness or weakness
- unusual weight gain or loss
- warmth on the skin
Incidence not known
- Clay colored stools
- dark urine
- dry skin and hair
- feeling cold
- hair loss
- hoarseness or husky voice
- nervousness
- sensitivity to heat
- slowed heartbeat
- stomach tenderness
- trouble sleeping
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
- Skin rash
- unable to sleep
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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