Aldesleukin

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Warning

Aldesleukin must be given in a hospital setting by a health care professional. It must be used with extreme caution in patients with heart or lung problems.

Rarely, this medication can cause capillary leak syndrome (CLS), a serious condition that can sometimes be fatal. If you develop any of the following signs of CLS, tell your doctor right away: swelling, severe dizziness, fainting, irregular heartbeat, chest pain (angina), trouble breathing, signs of kidney problems (such as change in the amount of urine), mental/mood changes, severe stomach/abdominal pain, black stools.

Aldesleukin can also make you more likely to get serious infections. Before using this drug, tell your doctor if you currently have any infections. Also, tell your doctor right away if you develop any of the following signs of infection: sore throat that doesn't go away, fever.

Rarely, this drug may cause a loss of consciousness. If this drug makes you unusually sleepy, stop using it and tell your doctor right away.

Precautions

See also Warning section.

Before using aldesleukin, tell your doctor or pharmacist if you are allergic to it; 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: kidney problems (such as glomerulonephritis), heart disease (such as fast/irregular heartbeat, recent heart attack, angina), liver disease, lung disease, stomach/intestinal problems (such as Crohn's disease, ischemic bowel, perforation, bleeding ulcers), high levels of calcium (hypercalcemia), organ transplant, thyroid disorders, a certain connective tissue disease (scleroderma), seizures, arthritis, diabetes, gallbladder problems (cholecystitis), a certain disease of blood vessels in the brain (cerebral vasculitis), a certain muscle/nerve disease (myasthenia gravis).

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

If you are scheduled to have any X-ray or scanning procedure using injectable dye (such as iodinated contrast), tell your doctor that you are using this medication.

Older adults may be at a greater risk for kidney effects or shortness of breath while using this drug.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using aldesleukin. Aldesleukin may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Side Effects

See also Warning section.

Fever, chills, stomach upset, dry skin, muscle stiffness, diarrhea, mouth sores, dizziness, drowsiness, headache, weight gain, nausea, vomiting, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor 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 right away if you have any serious side effects, including: swollen belly, muscle pain/weakness, difficulty speaking, trouble walking, vision changes (including temporary blindness), mental/mood changes (such as confusion, depression, agitation, hallucinations), unusual bleeding/bruising, thirst, flushing, rapid breathing, fast heartbeat, yellowing eyes/skin, dark urine, vomit that looks like coffee grounds, symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).

Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at www.fda.gov/medwatch.

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

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