Class Name(s):
Pronunciation:
Brand Name(s):
Denileukin diftitox injection and denileukin diftitox-cxdl injection are biologic medications (medications made from living organisms). Biosimilar denileukin diftitox-cxdl injection is highly similar to denileukin diftitox injection and work the same way as denileukin diftitox injection in the body. Therefore, the term denileukin diftitox injection products will be used to represent these medications in this discussion.
You may experience a serious or life-threatening reaction while you receive a dose of a denileukin diftitox injection product. You will receive each dose of medication in a medical facility, and your doctor will monitor you carefully while you are receiving the medication. Your doctor will prescribe certain medications to prevent these reactions. You will take these medications by mouth shortly before you receive each dose of a denileukin diftitox product. If you experience any of the following symptoms during or for 24 hours after your infusion, tell your doctor immediately: fever, chills, hives, difficulty breathing or swallowing, slowed breathing, or chest pain.
Some people who received a denileukin diftitox product developed life-threatening capillary leak syndrome (a condition that causes the body to keep excess fluid, low blood pressure, and low levels of a protein [albumin] in the blood). Capillary leak syndrome may occur up to 2 weeks after a denileukin diftitox product is given and may continue or get worse even after treatment is stopped. If you experience any of the following symptoms, call your doctor immediately: swelling of the hands, feet, ankles, or lower legs; weight gain; shortness of breath; fainting; dizziness or lightheadedness; or fast or irregular heartbeat.
Denileukin diftitox injection products may cause vision changes, including blurred vision, loss of vision, and loss of color vision. Vision changes may be permanent. If you experience any changes in vision call your doctor immediately.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to denileukin diftitox injection products.
WHY is this medicine prescribed?
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.
HOW should this medicine be used?
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.
Are there OTHER USES for this medication?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking denileukin diftitox injection products,
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
If you miss an appointment to receive a dose of a denileukin diftitox injection product, call your doctor right away.
What SIDE EFFECTS can this medicine cause?
Denileukin diftitox injection products may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
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.
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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://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:
What should I know about STORAGE and DISPOSAL of this medication?
This medication will be stored at your doctor's office or clinic.
What OTHER INFORMATION should I know?
Ask your pharmacist any questions you have about denileukin diftitox products.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: October 20, 2024.