Do not take aldesleukin without first talking to your doctor if you have:
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heart disease such as irregular heartbeats, angina (chest pain), or history of heart attack;
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lung or breathing problems;
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kidney disease;
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liver disease;
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seizure disorder;
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an infection;
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an organ transplant;
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central nervous system (CNS) impairment; or
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an autoimmune or inflammatory disorder such as Crohn’s disease, scleroderma, thyroid disease or thyroiditis, rheumatoid arthritis, diabetes, myasthenia gravis, Stevens-Johnson syndrome, and others.
You may not be able to take aldesleukin, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.
Aldesleukin is in the FDA pregnancy category C. This means that it is not known whether it
will be harmful to an unborn baby.
It is not known whether aldesleukin passes into breast milk.
Aldesleukin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.
Aldesleukin is administered by intravenous (into a vein) injection.
Your doctor will determine the correct amount and frequency of treatment with aldesleukin depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.
Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with aldesleukin to monitor progress and side effects.
Store vials of lyophilized aldesleukin in the refrigerator. Protect the vials from light and store them in a carton until time of use. Reconstituted or diluted aldesleukin is stable for up to 48 hours at refrigerated and room temperatures, 2 to 25C (36 to 77F). However, since this product contains no preservative, the reconstituted and diluted solutions should be stored in the refrigerator. Do not use any aldesleukin products beyond the expiration date printed on the vial.
Contact your doctor if you miss a dose of aldesleukin.
If you experience any of the following serious side effects from aldesleukin, contact your doctor immediately:
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an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
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decreased bone marrow function or blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or infection);
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capillary leak syndrome (leaking of blood plasma and fluid from the blood vessels), a condition that may lead to heart attack, severe breathing difficulties, stomach bleeding, kidney problems, and death;
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mood or behavior changes such as irritability, confusion, agitation, or hallucinations;
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problems with speech, walking, or coordination;
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severe drowsiness;
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seizures;
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difficulty breathing or unusual breath sounds;
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abdominal pain or swelling;
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swelling or fluid retention;
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fainting or irregular heart beats;
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severe nausea, vomiting, or diarrhea;
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rash; or
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new or worsening symptoms of an autoimmune or inflammatory condition.
Other, less serious side effects may be more likely to occur. Continue taking aldesleukin and talk to your doctor if you experience:
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tiredness or weakness; or
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diarrhea, nausea, vomiting, loss of appetite.
Side effects other than those listed here have also been reported. Discuss with your doctor any side effect that occurs during treatment with aldesleukin.
Aldesleukin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.
Serious side effects have been reported with the use of aldesleukin including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or infection); capillary leak syndrome, a condition that may lead to heart attack, severe breathing difficulties, stomach bleeding, kidney problems, and death; severe nausea, vomiting, diarrhea, and loss of appetite; and others. Talk to your doctor about the possible side effects from treatment with aldesleukin.
Do not have x-rays that involve the use of contrast media (dye) without first talking to your doctor. There may be an increased risk of an allergic reaction to the dye during and for a time following treatment with aldesleukin.
Aldesleukin may interact with other drugs that cause drowsiness, including antidepressants, antihistamines, pain relievers, anxiety medicines, seizure medicines, muscle relaxants, and others. Dangerous drowsiness may occur if aldesleukin is taken with any of these medications. Talk to your doctor before taking aldesleukin in combination with any other prescription or over-the-counter medicines.
Do not have x-rays that involve the use of contrast media (dye) without first talking to your doctor. There may be an increased risk of an allergic reaction to the dye during and for a time following treatment with aldesleukin.
Aldesleukin may interact with other drugs that cause drowsiness, including antidepressants, antihistamines, pain relievers, anxiety medicines, seizure medicines, muscle relaxants, and others. Dangerous drowsiness may occur if aldesleukin is taken with any of these medications. Talk to your doctor before taking aldesleukin in combination with any other prescription or over-the-counter medicines.
Side effects from aldesleukin may be increased by other medications that affect the kidneys, liver, heart, or other organ systems. Severe or irreversible reactions may occur. Do not take any other prescription or over-the-counter medications, including herbal or alternative medicine products, during treatment with aldesleukin without first talking to your doctor.
If for any reason an overdose is suspected, seek emergency medical attention or contact your healthcare provider immediately.
Symptoms of a aldesleukin overdose may be similar to side effects caused by the medication, although often more severe.