Denileukin Diftitox Injection

Denileukin diftitox injection products are used to treat cutaneous T-cell lymphoma (CTCL, a group of cancers of the immune system that first appear as skin rashes) in people whose disease has not improved, has gotten worse, or has come back after taking other medications. Denileukin diftitox is in a class of medications called cytotoxic proteins. It works by killing cancer cells.

Denileukin diftitox injection products come as a solution (liquid) or as a powder to be mixed with liquid to be injected over 30 to 60 minutes intravenously (into a vein). Denileukin diftitox injection products are administered by a doctor or nurse in a medical facility. It is usually given once a day for 5 days in a row. This cycle may be repeated every 21 days for up to eight cycles.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking denileukin diftitox injection products,

• tell your doctor and pharmacist if you are allergic to denileukin diftitox, denileukin diftitox-cxdl, any other medications, or any of the ingredients in denileukin diftitox or denileukin diftitox-cxdl. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had thyroid, kidney, or liver problems.
• tell your doctor if you are pregnant or plan to become pregnant. You must have a pregnancy test before you start treatment with a denileukin diftitox injection product. You should use birth control to prevent pregnancy during your treatment with a denileukin diftitox injection product and for 1 week after your final dose. Talk to your doctor about birth control methods that you can use. If you become pregnant while receiving a denileukin diftitox injection product, call your doctor. Denileukin diftitox injection products may harm the fetus.
• tell your doctor if you are breastfeeding. Do not breastfeed during your treatment and for 1 week after your final dose.

Unless your doctor tells you otherwise, continue your normal diet.

If you miss an appointment to receive a dose of a denileukin diftitox injection product, call your doctor right away.

Denileukin diftitox injection products may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• constipation
• decreased appetite
• change in ability to taste
• increased weight
• feeling tired
• pain, including back, muscle, or joint pain
• cough
• headache
• weakness
• rash
• itching
• difficulty falling asleep or staying asleep

Some side effects can be serious. If you experience any of these symptoms or any symptoms listed in the IMPORTANT WARNING section, call your doctor immediately.

• decreased urination; swelling of the face, arms, hands, feet, ankles, or lower legs; or unusual tiredness or weakness
• redness, swelling, oozing pus or other signs of skin infection
• feeling confused or any other sudden or unusual changes in behavior, thinking, or mood

Denileukin diftitox may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

This medication will be stored at your doctor's office or clinic.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• nausea
• vomiting
• fever
• chills
• weakness

Ask your pharmacist any questions you have about denileukin diftitox products.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.