Class: Biologic Therapy
Generic Name: Denileukin diftitox (den-i-LOO-kin DIF-ti-tocks)
Trade Name: Ontak®
For which conditions is this drug approved? Ontak is FDA approved for the treatment of a subtype of cutaneous T-cell lymphoma that recurs or persists following standard therapy. The cancer cells must express an abundance of receptors (proteins) for the immune stimulating agent interleukin –2 (IL-2). It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Ontak is comprised of two separate components. The first component is a diptheria toxin which is attached to the second component, IL-2. When Ontak is delivered, the IL-2 portion binds to the cancer cells that have IL-2 receptors. The Ontak then enters the cell, ultimately causing celllular death.
How is Ontak typically given (administered)? Ontak is administered intravenously (into a vein) and the dose depends on several factors, including the condition being treated, the size of the patient, the particular treatment regimen being used, and the overall health of the patient. Many patients experience an allergic reaction to Ontak during or immediately following administration. Although patients will be closely monitored for an allergic reaction, patients should tell their healthcare provider immediately if they experience difficulty breathing, back pain or lightheadedness.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Ontak. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.
In addition, patients will be monitored for an uncommon but serious condition called capillary leak syndrome. The syndrome is caused by fluid leaking out of veins and capillaries into surrounding tissue. This ultimately causes low blood pressure and a reduced volume of blood getting to organs. Physicians will monitor for capillary leak syndrome by checking blood pressure, levels of certain proteins in the blood, body weight, and swelling. Patients should notify a healthcare provider if they are experiencing these symptoms: difficulty breathing, sudden swelling or weight gain, dizziness, chest pain, changes in heart beat or rhythm, and/or little or no urine output for 12 hours.
What are the common (occur in 30% or more of patients) side effects of treatment with Ontak?
• Capillary leak syndrome (see above)
• Flu-like symptoms
• Decreased lymphocyte levels
• Low levels of protein (albumin) in the blood
• Abnormalities in liver function levels as determined by blood tests
• Nausea and vomiting
• Swelling of the hands and feet
• Loss of appetite
• Reduced blood pressure
What are the less common (occur in 10% to 29% of patients) side effects of treatment with Ontak?
• Difficulty breathing
• Shortness of breath
• Flushing of face/upper body
• Chest pain/tightness
• Back pain
• Muscle pain/joint pain
• Sore throat
• Numbness or tingling of hands or feet
• Abnormal levels of some electrolytes as determined by blood tests
• Low red blood cell levels – increases risk of anemia or blood transfusions
• Changes in heart rate
• Blood in the urine
• Cloudy urine
• Weight loss
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
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What can patients do to help alleviate or prevent discomfort and side effects?
• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• Eat small meals frequently to help alleviate nausea.
Are there any special precautions patients should be aware of before starting therapy?
• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
• Patients should inform their physician of any reaction to diphtheria toxin or interleukin-2.
• Patients who have had previous reactions to the diptheria immunization or IL-2 should speak with their physician about the risks of Ontak.
When should patients notify their physician?
• Difficulty breathing
• Skin rash or itching
• Chest pain
• Changes in heart beat
• Little or no urine output for 8-12 hours
• Sudden weight gain or swelling
• Persistent nausea and vomiting
• Persistent diarrhea
• Prolonged or extreme weakness
• Aching calf or thigh pain
• Unexplained bleeding (nosebleeds, bruising, blood in the urine, black tarry stools, etc)
• Cloudy urine
• Yellowing of the skin or eyes
• Extreme anxiety or nervousness
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.
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The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.