In the U.S.—

• Antineoplastic

Denileukin diftitox (DEN-i-loo-kin DIF-ti-toks) is used to treat cutaneous T-cell lymphoma, 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. It is available in the following dosage form(s):

Parenteral
• Injection (U.S.)

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 denileukin diftitox, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to denileukin diftitox, diptheria toxin, or interleukin-2. Also tell your health care professional if your are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Denileukin diftitox has not been studied in pregnant women. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether denileukin diftitox passes into human breast milk. However, breast-feeding is not recommended while you are receiving this medicine.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of denileukin diftitox in children with use in other age groups.

Older adults—Adverse effects such as anorexia, hypotension, anemia, confusion, rash, nausea, and/or vomiting may be especially likely to occur in elderly patients who may be more sensitive than younger adults to the effects of denileukin diftitox.

Dosing—

The dose of denileukin diftitox will be different for different patients. The dose that is used may depend on a number of things, including your size. Denileukin diftitox usually is given by a doctor or nurse in the hospital or outpatient clinic. If you have any questions about the proper dose of denileukin diftitox, ask your doctor.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted 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 immediately if any of the following side effects occur:

• More common
  • Back pain;  chest pain;  dizziness or faintness;  difficulty swallowing ;  fast or irregular heartbeat;  fever or chills;  infection;  rash;  shortness of breath;  swelling of face, feet, or lower legs;  warmth and flushing of skin 
  
  

• Less common
  • Abdominal pain, severe;  black, tarry stools;  cloudy urine;  blood in urine or stools;  cloudy urine;  cough or hoarseness accompanied by fever or chills;  headache, severe;  loss of coordination;  lower back pain or side pain accompanied by fever or chills;  painful or difficult urination accompanied by fever or chills ;  pain in groin or leg;  pinpoint red spots on skin;  slurring of speech;  sudden vision changes;  swelling or pain at injection site;  unusual bleeding or bruising;  weakness of arm and leg 
  
  

• Decreased urination , accompanied by nausea and loss of appetite  

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Difficulty swallowing;  loss of strength or energy;  nausea;  pain in joints and muscles;  unusual tiredness or weakness ;  vomiting 
  
  

• Rare
  • Dry, puffy skin;  increased heart rate ;  loss of appetite;  weight gain 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common

• Cough;  diarrhea;  skin rash;  sore throat 

• Less common or rare
  • Confusion;  constipation;  indigestion;  numbness or tingling of fingers, toes, or face;  runny nose;  trouble in sleeping 
  
  

Some side effects of denileukin diftitox may not develop until long after you have received the medicine, sometimes up to two weeks later.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.