Pronunciation:

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

Brand Names:

• Ontak

Dosage Forms:

• Injectable
• Solution

Warnings:

Serious and fatal infusion reactions may occur; therefore, patients treated with denileukin diftitox must be managed in a facility equipped and staffed for cardiopulmonary resuscitation. Treatment with denileukin diftitox should be immediately stopped and permanently discontinued after serious infusion reactions. Capillary leak syndrome resulting in death may also occur. Patients weight, edema, blood pressure and serum albumin levels should be monitored prior to and during denileukin diftitox treatment. Patients should also be monitored for loss of visual acuity and color vision .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Interleukin

Uses of This Medicine:

Denileukin diftitox is used to treat persistent or recurrent cutaneous T-cell lymphoma. This is a rare type of cancer that affects certain white blood cells and causes lesions to develop on the skin.

Denileukin diftitox interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other effects may also occur. Some of these may be serious and must be reported to your doctor. Some effects may occur after treatment with denileukin diftitox.

Denileukin diftitox is to be administered only by or under the supervision of your doctor or other health care professional.

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 in the pediatric population. Safety and efficacy have not been established.

Older adults—

Although appropriate studies on the relationship of age to the effects of denileukin diftitox have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of denileukin diftitox 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. 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:

• Heart disease—Use with caution. May increase risk for more serious side effects.

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 hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 30 to 60 minutes.

This medicine is usually given every day for 5 days. This 5-day treatment is given again every 21 days for several months, or until your body responds to the medicine.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause a serious side effect called an infusion reaction. This can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have fever, chills, breathing problems, chest pain, fast or pounding heartbeat, hives, or rash after you receive the injection.

Call your doctor right away if you have dizziness, faintness, or lightheadedness when getting up from a lying or sitting position; rapid weight gain; or swelling of hands, ankles, feet, or lower legs. These may be symptoms of a rare but serious condition called capillary leak syndrome.

Check with your doctor right away if you have any vision changes (e.g., decrease in vision, loss of color vision) while you are using this medicine. Your doctor may want you to have your eyes checked by an eye doctor.

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

bloating or swelling of the face, arms, hands, lower legs, or feet

blurred vision

body aches or pain

chest pain

confusion

cough

difficulty with breathing

difficulty with moving

difficulty with swallowing

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

ear congestion

fast or irregular heartbeat

feeling unusually cold

fever or chills

headache

loss of appetite

loss of strength or energy

loss of voice

muscle aching or cramping

muscle pains or stiffness

nasal congestion

nausea

pain in the joints and muscles

rapid weight gain

rash

runny nose

shivering

shortness of breath

sneezing

sore throat

sweating

swollen joints

tightness in the chest

tingling of the hands or feet

unusual tiredness or weakness

unusual weight gain or loss

vomiting

warmth and flushing of the skin

wheezing

Less common

Abdominal pain, severe

black, tarry stools

blood in the urine or stools

cloudy urine

cough or hoarseness accompanied by fever or chills

headache, severe

loss of coordination

lower back or side pain accompanied by fever or chills

pain in the groin or leg

painful or difficult urination accompanied by fever or chills

pinpoint red spots on the skin

slurring of speech

sudden vision changes

swelling or pain at the injection site

unusual bleeding or bruising

weakness of the arm and leg

Rare

Dry, puffy skin

increased heart rate

weight gain

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

Change in taste

diarrhea

itching

loss of taste

Less common

Constipation

indigestion

numbness or tingling of the fingers, toes, or face

runny nose

trouble with sleeping

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.