How does this medication work? What will it do for me?

Aldesleukin belongs to the group of cancer-fighting medications called biological response modifiers. It is a synthetic (manmade) medication designed to act like one of the body's natural defense cells known as interleukin-2. Aldesleukin is used to treat certain types of kidney cancer (metastatic renal cell carcinoma) and skin cancer (metastatic malignant melanoma). Aldesleukin fights cancer cells by helping the body's natural defense system seek out and destroy cancer cells.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each vial contains a sterile, white-to-off-white lyophilized cake that, when reconstituted with 1.2 mL Sterile Water for Injection, USP, each mL contains aldesleukin 18 million IU (1.1 mg), mannitol 50 mg and sodium dodecyl sulfate 0.18 mg, buffered with approximately 0.17 mg monobasic sodium phosphate, and 0.89 mg dibasic sodium phosphate to a pH of 7.5 (range 7.2 to 7.8). Preservative-free.

How should I use this medication?

Aldesleukin is available as an intravenous (into the vein) injection. The medication is injected through a site on the skin that has been specially prepared for this purpose. This medication is most often given as an intravenous infusion (injection given over 15 minutes) every 8 hours for a maximum of 14 doses. After a 9-day rest, another course of 14 doses may be given for a maximum of 28 doses per course. After a 7-week rest, it may be necessary to repeat the 28-dose treatment plan.

Aldesleukin will be injected by a doctor or by someone under direct supervision of a doctor in a hospital. The recommended dose of aldesleukin varies according to body weight.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

Very careful handling of this medication is required, and it is always given in a hospital or similar setting with access to sterile equipment for preparation.

It is important this medication be given exactly as recommended by your doctor. If you miss an appointment to receive aldesleukin, contact your doctor as soon as possible to reschedule your appointment.

As well as attacking cancer cells, aldesleukin can affect some of your normal cells. This can cause a number of side effects such as mouth sores. Keep track of any side effects and report them to your doctor, as suggested in the section "What side effects are possible with this medication?"

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not use this medication if you:

  • are allergic to aldesleukin, interleukin-2, or any of the ingredients of the medication
  • have experienced repetitive or hard-to-control seizures after treatment with aldesleukin
  • have had abnormal lung function tests
  • have had aldesleukin in the past and experienced abnormal heart rhythms, chest pain with ECG changes, cardiac tamponade, or required intubation for more than 72 hours or kidney dialysis for more than 72 hours, or were in coma for more than 48 hours
  • have had an abnormal thallium stress test
  • have had an organ transplant
  • have had bowel perforation (holes or tears in the gut) or ischemia (reduced blood flow to the gut) after aldesleukin treatment
  • have had stomach bleeding requiring surgery after aldesleukin treatment

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who uses this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people using this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abnormal dreams
  • appetite loss
  • constipation
  • diarrhea
  • dizziness
  • drowsiness
  • dry skin
  • flushed, red skin
  • hair loss
  • heartburn
  • itchy skin
  • joint or muscle pain
  • nausea and vomiting
  • runny nose
  • skin rash
  • skin redness with burning or itching
  • trouble sleeping
  • weakness
  • weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • anxiety
  • chills
  • confusion
  • fever
  • numbness and tingling
  • signs of bleeding (e.g., blood in the urine, vomiting blood, nosebleeds, unusual bleeding or bruising)
  • signs of breathing problems (e.g., shortness of breath, troubled breathing, wheezing, tightness in chest, fast or irregular breathing)
  • signs of changed mental status (e.g., confusion, irritability, or trouble speaking)
  • signs of decreased red blood cell production (e.g., unusual tiredness, pale skin)
  • signs of electrolyte imbalance (e.g., muscle pain or cramps, weakness, irregular heartbeat, lack of coordination, thirst, confusion)
  • signs of kidney problems, such as major decrease in urine output
  • signs of liver problems (e.g., darkening of urine, pale stools, yellow eyes or skin)
  • sores in the mouth and on the lips
  • stomach pain
  • swelling of the ankles, feet, hands
  • symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
  • symptoms of irregular heart beat (e.g., chest pain, dizziness, rapid, pounding heartbeat, shortness of breath)
  • symptoms of low blood pressure (e.g., fainting, dizziness, lightheadedness, blurred vision, nausea)
  • symptoms of low blood sugar (e.g., cold sweat, cool pale skin, headache, fast heartbeat, weakness)
  • symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)

Seek immediate medical attention if any of the following occur:

  • chest pain
  • severe stomach pain
  • signs of bleeding in the stomach (e.g., bloody, black, or  tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
  • signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
  • signs of heart complications (e.g., chest pain; changes in heart rhythm; dizziness; swelling in hands, feet, or abdomen)
  • signs of infection (e.g., cough or hoarseness, sore throat, chills, fever, swollen or painful glands, unusual tiredness or weakness, painful or difficult urination)
  • signs of sepsis (blood infection; e.g., fever; dizziness; chills; very high or very low body temperature; low blood pressure; pounding or rapid heartbeat; rapid, shallow breathing)
  • signs of severe skin reaction (e.g., skin blisters, severe rash or itching, pinpoint red spots on the skin, blisters on the skin, white spots on lips or in the mouth)
  • swollen or enlarged stomach

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Autoimmune conditions: This medication may worsen any inflammatory or autoimmune conditions, including diabetes mellitus, inflammation of the thyroid, Crohn's disease, and inflammatory arthritis.

Birth control: Women who could become pregnant and men whose partners who could become pregnant must use an effective method of birth control while using this medication.

Blood clotting: This medication can reduce the number of platelet cells in the blood. Platelets help the blood to clot, and a shortage could make you bleed more easily. Tell your doctor of any signs that your blood is not clotting as quickly as usual. Such symptoms may include black and tarry stools, blood in the urine, easy bruising, or cuts that won't stop bleeding.

Nervous system problems: Hallucinations, speech difficulty, agitation, and changes in mental status have been reported with aldesleukin. If you experience any changes in thinking, movement or mood, contact your doctor immediately.

Diabetes: This medication may affect your blood glucose (sugar) levels. You and your doctor should monitor your sugar levels closely while using this medication.

Drowsiness/reduced alertness: Aldesleukin may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how this medication affects you.

Fertility: Temporary or permanent sterility may occur with the use of aldesleukin.

Heart conditions: Aldesleukin may cause damage to the heart and should not be used by people with heart disease. If you experience symptoms of heart trouble, such as chest pain, abnormal heart rhythm, sudden dizziness, fluid retention, or swelling, contact your doctor as soon as possible.

Infections: Aldesleukin may increase the risk of getting an infection. If you have an indwelling central line or have an existing infection, speak to your doctor about how to prevent infections while using this medication. If you develop any signs or symptoms of an infection (e.g., fever, cough, chest pain, difficult or painful urination, or skin redness, warmth, or swelling), contact your doctor.

Kidney function: Decreased kidney function or kidney disease may cause this medication to build up in the body, causing side effects. This medication also affects kidney function and should not be used by people with kidney disease or decreased kidney function. Your doctor will monitor your kidney function during treatment with aldesleukin with blood tests.

Liver function: This medication can affect liver function and should not be used by people with liver disease or decreased liver function. Your doctor will monitor your liver function during treatment with aldesleukin with blood tests. Report any signs of liver damage such as darkening urine, pale stools, or yellow skin or eyes to your doctor as soon as possible.

Low blood pressure: This medication can cause low blood pressure: If you experience severe dizziness, especially when standing from a lying or sitting position, contact your doctor.

Seizure disorders: Aldesleukin can cause seizures. If you have a seizure disorder, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Skin reactions: Aldesleukin has been linked to serious skin reactions. If you experience symptoms of a serious skin reaction (such as skin rash; redness of the skin; skin peeling; or blisters on the lips, eyes, or mouth) with fever, chills, headache, cough, or body aches, contact your physician immediately.

Pregnancy: There are no adequate studies of use of this medication by pregnant women. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if aldesleukin passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication have not been established for use by children.

Seniors: Seniors may be at higher risk of experiencing the side effects of this medication.

What other drugs could interact with this medication?

There may be an interaction between aldesleukin and any of the following:

  • 5-ASA medications (e.g., mesalamine, olsalazine, sulfasalazine)
  • alcohol
  • aliskiren
  • alpha-agonists (e.g., clonidine, methyldopa)
  • alpha-blockers (e.g., alfuzosin, doxazosin, tamsulosin)
  • angiotensin converting enzyme inhibitors (ACEIs; e.g., captopril, lisinopril, ramipril)
  • angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
  • antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
  • antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
  • BCG vaccine
  • beta-blockers (e.g., acebutolol, propranolol, metoprolol)
  • brimonidine
  • calcium channel blockers (e.g., diltiazem, nifedipine, verapamil)
  • cancer medications (e.g., asparaginase, cisplatin, dacarbazine, doxorubicin, interferon-alfa, methotrexate, tamoxifen, vinblastine)
  • conivaptan
  • corticosteroids (e.g., prednisone, dexamethasone)
  • diuretics (e.g., furosemide, hydrochlorothiazide)
  • duloxetine
  • hydralazine
  • levodopa
  • muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)
  • nitrates (e.g., isosorbide dinitrate, nitroglycerin)
  • obinutuzumab
  • opioid pain relievers (e.g., codeine, fentanyl, oxycodone, morphine)
  • pentoxifylline
  • phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
  • radiocontrast dye
  • tricyclic antidepressants (e.g., clomipramine, desipramine, imipramine)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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