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Ontak IV

Important Note

Warnings
Uses
Side Effects
Precautions
Interactions
Overdose
Ontak IV Warnings

Unlikely but very serious (possibly fatal) side effects may occur during treatment with denileukin diftitox. Tell your doctor immediately if you have any unusual symptoms during the infusion (see Side Effects section). Also tell your doctor immediately if you experience any of the following symptoms: dizziness, lightheadedness, fainting, sudden weight gain, swelling ankles/feet, or vision changes (e.g., loss of vision/color vision).

Ontak IV Uses

Denileukin diftitox is used to treat a certain type of cancer (cutaneous T-cell lymphoma, also known as CTCL) in patients whose cancer keeps returning or in patients who have not responded to other cancer chemotherapy treatment. It works by killing certain blood/cancer cells from your immune system (e.g., B cells, T cells).

How to use Ontak IV

This medication is given by injection into a vein by a health care professional.

Dosage is based on your weight, medical condition, and response to treatment. This medication is usually given over at least 15 minutes for 5 days in a row. This treatment cycle is usually repeated every 21 days or as directed by your doctor.

Ontak IV Side Effects

See also Warning section.

Dizziness, back pain, mild rash/itching, flushing, fever, chills, muscle/joint pain, nausea, vomiting, or diarrhea may occur during or after the infusion. Tell your doctor or pharmacist immediately if any of these effects occur, persist, or worsen. Your doctor may stop/slow down the infusion, and/or prescribe additional medications to help control these symptoms. Headache, loss of appetite, sweating, or trouble sleeping may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor immediately if any of these serious side effects occur: extreme thirst, very dry mouth, decreased urination, weakness, muscle cramps, chest pain/tightness, shortness of breath, fast/slow/irregular heartbeat, trouble swallowing, confusion, pain/redness/swelling of arms/legs/injection site, numbness/tingling of arms/legs.

This medication may cause very serious blood disorders (low number of blood cells such as red cells, white cells, and platelets). This effect can cause anemia, decrease your body's ability to fight an infection, or cause your body to bruise or bleed more easily. Tell your doctor immediately if you develop any of the following symptoms: signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, unusual tiredness, fast/pounding heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Ontak IV Precautions

Before receiving denileukin diftitox, tell your doctor or pharmacist if you are allergic to it; or to diphtheria toxin/vaccines; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart/blood vessel disease, any current infections.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk and the effect on a nursing infant is unknown. Discuss the risks and benefits with your doctor before breast-feeding.

Ontak IV Interactions

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Ontak IV Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES:

Laboratory and/or medical tests (e.g., weight, blood pressure, albumin levels, complete blood count, liver/kidney function tests, checking for arm/leg swelling) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE:

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor immediately to establish a new dosing schedule.

STORAGE:

Not applicable. This medication is given in a hospital and will not be stored at home.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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