Ontak

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Ontak


Generic Name: Denileukin Diftitox (DEN-i-loo-kin DIF-ti-toks)
Brand Name: Ontak

Ontak is used for:

Treating certain kinds of lymphoma. It may also be used for other conditions as determined by your doctor.

Ontak is an anticancer agent called a fusion protein. It works by interfering with the growth of cancer cells, which results in the death of the cells.

Do NOT use Ontak if:

  • you are allergic to any ingredient in Ontak , including diphtheria toxin or interleukin-2

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ontak :

Some medical conditions may interact with Ontak . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have heart disease or low blood levels of albumin

Some MEDICINES MAY INTERACT with Ontak . However, no specific interactions with Ontak are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ontak may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ontak :

Use Ontak as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Ontak is usually administered as an infusion at your doctor"s office, hospital, or clinic. Ask your doctor or pharmacist any questions that you may have about Ontak .
  • Do not shake; mix solution by gently swirling it.
  • If Ontak contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
  • If nausea, vomiting, diarrhea, or loss of appetite occurs, do not discontinue your medicine. Ask your doctor or pharmacist for ways to lessen these effects.
  • Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for proper disposal.
  • If you miss a dose of Ontak , contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Ontak .

Important safety information:

  • Ontak may cause dizziness or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Ontak . Using Ontak alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
  • Ontak may lower your body"s ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first. Notify your doctor of any signs of infection, including fever, sore throat, rashes, or chills.
  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Ontak .
  • LAB TESTS, including complete blood cell counts, blood chemistry, liver function, kidney function, blood pressure, and serum albumin, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Ontak with caution in the ELDERLY because they may be more sensitive to its effects.
  • Use Ontak with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Ontak during pregnancy. It is unknown if Ontak is excreted in breast milk. Do not breast-feed while taking Ontak .

Possible side effects of Ontak :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal skin sensations; confusion; constipation; cough; diarrhea; dizziness; headache; indigestion; injection site reaction; lightheadedness; loss of appetite; muscle or joint aches; nausea; nervousness; pain; runny nose; sleeplessness; sweating; vomiting; weakness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; chest pain; difficulty swallowing; fainting; fast or irregular heartbeat; flu-like symptoms (eg, fever, chills, sore throat); leg pain; severe diarrhea with nausea and vomiting; sudden unusual weight gain; swelling of the hands, legs, or ankles; vision changes (eg, loss of color vision).

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Ontak :

Store Ontak frozen at or below 14 degrees F (−10 degrees C). The vials may be thawed in the refrigerator at 36 to 46 degrees F (2 to 8 degrees C) for not more than 24 hours or at room temperature for 1 to 2 hours. Ontak MUST NOT BE HEATED. Do not refreeze. Once diluted, the prepared solutions should be administered within 6 hours. Unused portions should be properly discarded immediately. Keep Ontak out of the reach of children and away from pets.

General information:

  • If you have any questions about Ontak , please talk with your doctor, pharmacist, or other health care provider.
  • Ontak is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Ontak . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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