Ontak

Before using denileukin diftitox, tell your doctor if you have heart disease.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether denileukin diftitox passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Some patients receiving denileukin diftitox have had permanent changes in their vision or ability to see colors. Talk with your doctor about your individual risk. Tell your doctor if you have any vision changes during your treatment.

Denileukin diftitox is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection in a hospital or clinic setting. The injection normally takes about 15 minutes or longer. During this time you will be observed for side effects.

Denileukin diftitox is usually given each day for five days, followed by three weeks off the medication.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis before and during your treatment. It is important that you not miss any scheduled visits to your doctor.

Contact your doctor for instructions if you miss a dose.

You may have a reaction from a denileukin diftitox injection within hours or days after receiving the injection. Call your doctor promptly if you have one or more of these symptoms: fever, chills, weakness, muscle or joint pain, nausea, vomiting, or stomach upset.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• blurred vision, changes in color vision;

• swelling in your hands, ankles, or feet;

• easy bruising or bleeding, unusual weakness;

• fever, chills, body aches, cough, flu symptoms;

• fast heart rate;

• feeling light-headed, fainting;

• back pain, trouble breathing, chest pain or tightness;

• trouble swallowing, tight feeling in your throat; or

• warmth or redness in your face, neck, or chest.

Other less serious side effects are more likely to occur, such as:

• headache, dizziness, or nervousness;

• numbness or tingling;

• runny or stuffy nose;

• skin itching or rash;

• weight gain or loss;

• mild diarrhea or constipation; or

• nausea, vomiting, loss of appetite.

You should not use denileukin diftitox if you have ever had an allergic reaction to a diphtheria vaccine or to medicines containing interleukin-2 (IL-2).

Denileukin diftitox is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection in a hospital or clinic setting. The injection normally takes about 15 minutes or longer. During this time you will be observed for side effects.

You may have a reaction from a denileukin diftitox injection within hours or days after receiving the injection. Call your doctor promptly if you have one or more of these symptoms: fever, chills, weakness, muscle or joint pain, nausea, vomiting, or stomach upset.

Some patients receiving denileukin diftitox have had permanent changes in their vision or ability to see colors. Talk with your doctor about your individual risk. Tell your doctor if you have any vision changes during your treatment.

There are no restrictions on food, beverages, or activity while using denileukin diftitox unless your doctor has told you otherwise.

There may be other drugs that can affect denileukin diftitox. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Seek emergency medical attention if you think you have received too much of this medicine.

Symptoms of a denileukin diftitox overdose may include severe nausea or vomiting, fever, chills, and extreme weakness.