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aldesleukin (cont.)

What should I discuss with my healthcare provider before receiving aldesleukin (Proleukin)?

You should not receive this medication if you are allergic to aldesleukin or interleukin-2, or if you have:

  • an infection caused by bacteria;
  • if you have received an organ transplant;
  • if you have recently had an abnormal lung function test; or
  • if you have recently had an abnormal exercise test showing decreased blood flow to your heart.

You may not be able to receive aldesleukin if you have had any of these side effects while receiving aldesleukin in the past:

  • irregular heart rhythm;
  • chest pain;
  • a build-up of fluid around your heart;
  • kidney failure;
  • seizures;
  • psychosis (thinking problems, hallucinations, or changes in personality);
  • stomach or intestinal bleeding; or
  • if you needed a breathing tube.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely receive aldesleukin:

  • heart disease, angina (chest pain), a heart rhythm disorder, or history of heart attack;
  • lung or breathing problems;
  • kidney disease;
  • liver disease;
  • gallbladder disease;
  • high levels of calcium in your blood (hypercalcemia);
  • a thyroid disorder;
  • diabetes;
  • a seizure disorder;
  • mental illness or neurologic problems; or
  • an autoimmune disorder such as Crohn's disease, scleroderma, arthritis, myasthenia gravis, or a chronic skin disorder.

FDA pregnancy category C. It is not known whether aldesleukin is harmful to an unborn baby. Before receiving this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether aldesleukin 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.

How is aldesleukin given (Proleukin)?

Aldesleukin is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take at least 15 minutes to complete.

Aldesleukin is usually given every 8 hours for up to 5 days, followed by a 9-day rest period and then repeated.

Your breathing, blood pressure, oxygen levels, kidney function, and other vital signs will be watched closely while you are receiving aldesleukin. Your blood will also need to be tested daily during treatment, and you may also need chest x-rays.

After 4 weeks off the medication, your doctor will examine you to determine if you need to be treated again with aldesleukin.

If you need to have any type of x-ray or other scan using a contrast agent (a dye that is used to help blood vessels, organs, and other non-bony tissues appear more clearly on the x-ray or scan), be sure the doctor knows ahead of time if you have recently received aldesleukin. Some people treated with aldesleukin or similar medication have had unusual allergic reactions to contrast agents used within weeks to several months later.

Report Problems to the Food and Drug Administration

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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