Pronunciation:

den-i-LOO-kin DIF-ti-tox - cxdl

Brand Names:

• Lymphir

Dosage Forms:

• Powder for Solution

Warnings:

Capillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving denileukin diftitox-cxdl. Monitor patients for signs and symptoms of CLS during treatment. Withhold denileukin diftitox-cxdl until CLS resolves, or permanently discontinue based on severity .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Denileukin Diftitox

Uses of This Medicine:

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 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 denileukin diftitox-cxdl 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 denileukin diftitox-cxdl injection in the elderly.

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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Cholera Vaccine
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Rotavirus Vaccine, Live

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 of 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.

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 While Using This Medicine:

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 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

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.