Aldesleukin Solution, Reconstituted (Recon Soln)

COMMON BRAND(S): Proleukin

GENERIC NAME(S): Aldesleukin

WARNINGS:

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.

Infrequently, 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: persistent sore throat, 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.

Who should not take Aldesleukin Solution, Reconstituted (Recon Soln)?

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Uses

Uses

Aldesleukin is used to treat kidney or skin cancer. This medication is the same as a substance that your body normally makes (interleukin-2). In the body, this drug is thought to work by affecting the body's natural defenses (immune system). This effect slows or stops cancer cell growth.

How to use Aldesleukin Solution, Reconstituted (Recon Soln)

This medication is given by injection into a vein over 15 minutes by a health care professional. It may also be given in other ways as directed by your doctor.

This medication is usually given every 8 hours for 5 days in a row. However, your doctor may decide to delay or stop your treatment depending on how you respond to this drug. After this treatment period, you will be given time to rest and recover before getting more of this medication. A course of therapy may include up to 28 doses of this medication. To make sure that you receive each scheduled dose as directed, it is important to keep all of your medical appointments while receiving this medication. Depending on your response, your doctor may decide that a second course would be helpful.

Dosage is based on your medical condition, weight, response to treatment, and your side effects.

Side Effects

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 persist or worsen, tell your doctor or pharmacist promptly.

People using this medication may 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 right away if any of these unlikely but serious side effects occur: swollen belly, muscle pain/weakness, confusion, difficulty speaking, trouble walking, vision changes (including temporary blindness), mental/mood changes (e.g., depression, agitation, hallucinations), unusual bleeding/bruising, thirst, flushing, rapid breathing, symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).

Tell your doctor right away if any of these rare but very serious side effects occur: fast heartbeat, yellowing eyes/skin, dark urine, vomit that looks like coffee grounds.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest/jaw/left arm pain, seizures.

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 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.

Precautions

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, heart disease (e.g., fast/irregular heartbeat, recent heart attack, angina), liver disease, lung disease, stomach problems (e.g., ischemic bowel, perforation, bleeding ulcers), high levels of calcium (hypercalcemia), history of organ transplant, seizures.

This medication may worsen certain types of immune system disorders (autoimmune and inflammatory type). Before using this medication, tell your doctor or pharmacist if you have any of the following disorders: a certain bowel disease (Crohn's disease), a certain connective tissue disease (scleroderma), thyroid disorders, arthritis, diabetes, a certain muscle/nerve disease (myasthenia gravis), a certain kidney disorder (glomerulonephritis), gallbladder problems (cholecystitis), a certain disease of blood vessels in the brain (cerebral vasculitis).

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 (e.g., iodinated contrast), tell your doctor that you are using this medication.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at a greater risk for kidney effects or shortness of breath while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Women who may become pregnant should use an effective form of birth control while using this medication. Discuss the use of birth control and the risks and benefits of using this medication with your doctor.

It is unknown if this medication passes into breast milk. Because of possible harm to a nursing infant, breast-feeding is not recommended while using this medication. Consult your doctor before breast-feeding.

Interactions

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are: blood pressure drugs (including beta blockers such as metoprolol), corticosteroids (e.g., hydrocortisone, methylprednisolone, prednisone), interferon alfa, tamoxifen, drugs that can cause kidney problems (including indomethacin, aminoglycosides such as gentamicin), other anti-cancer medication (e.g., asparaginase, cisplatin, dacarbazine, methotrexate).

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Overdose

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Because there may be breaks in treatment, it is important to keep all medical/infusion appointments.

Your doctor should check your heart, lungs, kidneys, liver, and mental state before you start treatment with this medication. Laboratory and/or medical tests (e.g., complete blood counts, kidney/liver/lung function, chest X-ray, blood pressure, pulse, mental status, weight, urine output) should also 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 to establish a new dosing schedule.

Storage

Not applicable. This medication is given in a hospital and will not be stored at home.Information last revised October 2019. Copyright(c) 2019 First Databank, Inc.

Images

Sorry. No images are available for this medication.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.