Ontak®

Class: Biologic Therapy

Generic Name: Denileukin diftitox (den-i-LOO-kin DIF-ti-tocks)

Trade Name: Ontak®

For which conditions is this drug approved? Denileukin diftitox 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? Denileukin diftitox is comprised of two separate components. The first component is a diptheria toxin which is attached to the second component, IL-2. When denileukin diftitox is delivered, the IL-2 portion binds to the cancer cells that have IL-2 receptors. The diptheria toxin then enters the cell, ultimately causing celllular death.

How is denileukin diftitox typically given (administered)? Denileukin diftitox 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 denileukin diftitox 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 denileukin diftitox. 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 denileukin diftitox?

Capillary leak syndrome (see above)

Flu-like symptoms

Fever

Chills

Decreased lymphocyte levels

Low levels of protein (albumin) in the blood

Abnormalities in liver function levels as determined by blood tests

Nausea and vomiting

Diarrhea

Weakness

Swelling of the hands and feet

Infection

Loss of appetite

Pain

Reduced blood pressure

Rash

What are the less common (occur in 10% to 29% of patients) side effects of treatment with denileukin diftitox?

Difficulty breathing

Shortness of breath

Flushing of face/upper body

Cough

Dizziness

Diarrhea

Chest pain/tightness

Back pain

Muscle pain/joint pain

Itching

Sore throat

Headache

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

Anxiety

Nervousness

Sweating

Dehydration

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.

What can patients do to help alleviate or prevent discomfort and side effects?

Pay careful attention to the physicians 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 denileukin diftitox.

When should patients notify their physician?

Lightheadedness

Dizziness

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

Fever

Chills

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.

Copyright © 2018 CancerConnect Last updated 01/05.

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