Denileukin diftitox

Denileukin diftitox is used in adults to treat cutaneous (of the skin) T-cell lymphoma after at least one other treatment has failed or is no longer effective.

Denileukin diftitox may also be used for reasons not mentioned in this medication guide.

Your doctor will do tests to ensure that denileukin diftitox is the right treatment for you.

Denileukin diftitox is injected into a vein by a healthcare provider.

Denileukin diftitox is given in a 21-day treatment cycle. You will receive an injection only on specific days during this cycle.

After receiving an injection, you will be closely monitored to ensure you do not have an allergic reaction or serious side effects.

Your healthcare provider may give you other medications to help prevent an allergic reaction or serious side effects.

You may need to have frequent medical tests, including vision exams.

Doses are based on weight. Your dose may change if you gain or lose weight.

Denileukin diftitox can cause a rare but serious side effect known as capillary leak syndrome. Call your doctor or seek emergency medical attention right away if you notice signs of this condition: a stuffy or runny nose followed by tiredness, thirst, decreased urination, trouble breathing, and sudden swelling or weight gain.

Tell your doctor if you have or have ever had:

• vision problems; or
• liver disease.

May harm an unborn baby. Do not use if you are pregnant. Use effective birth control while using Denileukin diftitox and for at least 7 days after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using denileukin diftitox, and for at least 7 days after your last dose.

Get emergency medical help if you notice signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Some side effects may happen during the injection. Let your medical caregiver know if you feel dizzy, nauseous, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Capillary leak syndrome is a rare but serious side effect. Contact your doctor right away if you have signs of this condition: low blood pressure, a stuffy or runny nose followed by tiredness, thirst, decreased urination, trouble breathing, and sudden swelling or weight gain.

Denileukin diftitox may cause serious side effects. Call your doctor immediately if you experience:

• blurred vision, changes in clarity, sharpness, or color vision; or
• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed, reduced, or permanently stopped if you have certain side effects.

Common side effects of denileukin diftitox may include:

• nausea, constipation;
• rash, chills, fever;
• swelling in any part of your body;
• feeling very tired;
• bone, muscle, or joint pain; or
• abnormal blood tests.

This is not a complete list of side effects and others may occur. Contact your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Lymphoma:

9 mcg/kg/day or 18 mcg/kg/day by IV infusion over 30 to 60 minutes for 5 consecutive days every 21 days for 8 cycles.Comments:-Pre-medicate with an antihistamine and acetaminophen prior to each infusion.-Withhold treatment if serum albumin levels are less than 3.0 g/dL.-Discontinue for adverse infusion reactions.-Do not administer as a bolus injection.Use: Treatment of persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor.

Call your doctor for instructions if you miss an appointment for your Denileukin diftitox injection.

In a medical setting, an overdose would be treated quickly.

Follow your doctor's instructions about any limits on food, drinks, or activities.

Other drugs may affect denileukin diftitox, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.