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Proleukin

aldesleukin
Used for Melanoma, Renal Cancer
Used for Melanoma, Renal Cancer

Proleukin (aldesleukin) is an immunotherapy medication also known as cytokine therapy. It treats skin cancer and kidney cancer that has spread to other parts of the body. But it's not a first-choice option for these conditions because it can cause serious side effects. Typically, Proleukin (aldesleukin) is infused into the veins 3 times a day for 5 days, through 2 cycles. Proleukin (aldesleukin) must be given in a special facility with the staff and equipment needed to treat severe side effects, such as low blood pressure and heart problems.

Reviewed by:
reviewer
Sonja Jacobsen, PharmD, BCPS, BCOP
reviewer
Connie Zheng, PharmD
Last reviewed on November 30, 2023
BasicsSide effectsPros & consPharmacist tipsFAQsWarningsDosageInteractionsContraindicationsReferencesPricesMedicare
basics-icon

What is Proleukin (aldesleukin)?

What is Proleukin (aldesleukin) used for?

How Proleukin (aldesleukin) works

Proleukin (aldesleukin) is a man-made form of an immune protein (cytokine) found naturally in your body called interleukin-2 (IL-2). This protein plays an important role in the immune system by activating white blood cells in the body to help fight against invaders, like cancer. By acting just like IL-2, Proleukin (aldesleukin) turns on your immune system to target and kill cancer cells.

Drug Facts

Common BrandsProleukin
Drug ClassBiological response modulator
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
basics-icon

What are the side effects of Proleukin (aldesleukin)?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

  • Lower blood pressure (71%)
  • Diarrhea (67%)
  • Producing less urine (63%)
  • Chills (52%)
  • Vomiting (50%)
  • Trouble catching your breath (43%)
  • Rash (42%)
  • Higher bilirubin levels (40%)
  • Low blood cell count (up to 37%)
  • Nausea (35%)
  • Confusion (34%)
  • Higher creatinine levels (33%)
  • Fever (29%)
  • Swelling in the arms, legs, feet (28%)
  • Malaise (27%)

Other Side Effects

  • Lung congestion or rattling sound
  • Itching
  • Weakness
  • Mouth sores
  • Sleepiness
  • Lower appetite
  • Weight gain
  • Peeling skin

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.
  • Capillary leak syndrome: low blood pressure, swelling of body, arms, and legs, diarrhea, thickened blood
  • Severe skin reaction: painful blisters, skin wounds, peeling skin, or red irritated eyes, sores in the mouth, nose, throat, or eyes
  • Serious allergic reactions: trouble breathing, hives, tightness in the throat, dizziness, fast heartbeat, feeling confused, diarrhea, nausea, stomach pain
  • Serious infections: fever, tiredness, chills, cough, trouble breathing
  • Liver damage: dark urine, right-sided stomach pain, yellowing of the eyes or skin, tiredness, loss of appetite, nausea, vomiting
  • Kidney problems: blood in the urine, painful urination, dark urine, not producing any urine

Source: DailyMed

The following side effects have also been reported

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Agitation

confusion

diarrhea

dizziness

drowsiness

fever or chills

mental depression

nausea and vomiting

shortness of breath

sores in the mouth and on lips

tingling of the hands or feet

unusual decrease in urination

unusual tiredness or weakness

weight gain of 5 to 10 pounds or more

Less common

Bloating and stomach pain

blurred or double vision

faintness

fast or irregular heartbeat

loss of taste

rapid breathing

redness, swelling, and soreness of the tongue

trouble with speaking

yellow eyes and skin

Rare

Changes in menstrual periods

clumsiness

coldness

convulsions (seizures)

listlessness

muscle aches

pain or redness at injection site

sudden inability to move

swelling in the front of the neck

swelling of the feet or lower legs

weakness

Less common

Black, tarry stools

blisters on the skin

blood in the urine

bloody vomit

chest pain

cough or hoarseness

lower back or side pain

painful or difficult urination

pinpoint red spots on the skin

stomach pain (severe)

unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Dry skin

loss of appetite

skin rash or redness with burning or itching, followed by peeling

unusual feeling of discomfort or illness

Less common

Constipation

headache

joint pain

muscle pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

pros-and-cons

Pros and cons of Proleukin (aldesleukin)

thumbs-up

Pros

Each treatment course is only 5 days

Uses your body’s immune system to help fight cancer

Treatment course can be repeated

thumbs-down

Cons

Injection only

Raises risk of infection

Can only be given at specialized treatment centers because of risk of serious side effects

pharmacist-tips

Pharmacist tips for Proleukin (aldesleukin)

pharmacist

  • Let your healthcare provider know if you're taking medications to lower your blood pressure because Proleukin (aldesleukin) can also lower blood pressure. Your provider will likely ask you to stop taking the blood pressure medications to prevent a serious interaction with Proleukin (aldesleukin).

    • Proleukin (aldesleukin) can put you at higher risk for developing an infection because it lowers your blood cell counts. Your provider will order blood work daily while you're receiving Proleukin (aldesleukin) to check your levels. Contact your provider if you develop a fever, which can be a sign of infection. It's important that your care team treat the infection early.

      • Proleukin (aldesleukin) raises your risk of serious infection. Even after you leave the hospital, it's important to wash your hands often and limit coming in contact with large crowds or people who might be sick. If you need to be around people, consider wearing a face mask, especially if you plan to be in a crowded, indoor setting.

        • To lower the risk of nausea and diarrhea while taking Proleukin (aldesleukin), consider eating foods that are part of the BRAT diet. These foods (e.g., applesauce, bananas, oatmeal) are easier on your stomach. Try to avoid foods that can worsen your symptoms, like greasy, spicy, or acidic foods.

          • It's important to take good care of your teeth and mouth while receiving Proleukin (aldesleukin) to prevent mouth sores. Consider using a soft bristle toothbrush and brushing your teeth 2 to 3 times a day.

            • Let your healthcare provider know if you develop mouth sores while receiving Proleukin (aldesleukin). They can recommend ways to ease your symptoms, such as rinsing your mouth with a baking soda and salt water rinse, or sucking on ice chips.

              • If you experience dry, itchy skin while receiving Proleukin (aldesleukin), you can use an mild, fragrance-free cream or lotion rehydrate your skin. Try to avoid scratching or breaking the skin as this might raise your risk of infection.

                • Proleukin (aldesleukin) might cause serious harm to an unborn baby. If you’re able to become pregnant, you should use birth control (e.g., birth control pills or condoms) while receiving Proleukin (aldesleukin).

                  • If you need to get imaging with iodinated contrast material, let your provider know that you've received Proleukin (aldesleukin), especially if it has been less than a month since your last dose. You might be at higher risk for having a serious allergic reaction to the contrast material (e.g., rash, chills, and fever) after receiving Proleukin (aldesleukin).

                    faqs

                    Frequently asked questions about Proleukin (aldesleukin)

                    Is Proleukin (aldesleukin) a type of chemotherapy?
                    No, Proleukin (aldesleukin) isn't chemotherapy; it's a type of immunotherapy. Chemotherapy works by directly killing cancer cells that are quickly multiplying in your body. Immunotherapy, such as Proleukin (aldesleukin), fights cancer by enlisting the help of the body's immune system.
                    Where can I receive treatment with Proleukin (aldesleukin)?
                    You’ll receive Proleukin (aldesleukin) at a hospital or treatment center that specializes in Proleukin (aldesleukin) treatment. This is because Proleukin (aldesleukin) can cause serious, and sometimes life-threatening side effects, such as breathing problems and heart problems. The specialized facilities have healthcare teams who are equipped to monitor for and treat these serious side effects. If your provider thinks Proleukin (aldesleukin) treatment is right for you, they’ll connect you with a specialized treatment center.
                    How often is Proleukin (aldesleukin) given?
                    People usually receive 2 cycles of Proleukin (aldesleukin), each lasting 5 days. During each cycle, Proleukin (aldesleukin)] is typically given three times a day for 5 days in a row. In between the 2 cycles, there's a 9-day rest period where you won't receive any medication. In the weeks following treatment, healthcare provider will check how your cancer is responding to the medication. If needed, they might recommend additional course(s) of Proleukin (aldesleukin) at a later time.
                    What premedications will I receive before my Proleukin (aldesleukin) treatment?
                    Proleukin (aldesleukin) infusions can cause side effects, such as fever and stomach irritation. Your provider will let you know about what premedications you might need before your first Proleukin (aldesleukin) to help. They might give you anti-nausea medications to help with nausea and vomiting. They'll likely also give you acetaminophen (Tylenol) to lower your risk of fever, and famotidine (Pepcid) to prevent stomach upset. If you have an indwelling catheter, like a central line, your provider might give you an antibiotic to help prevent an infection.
                    Is Proleukin (aldesleukin) safe while breastfeeding?
                    You're recommended to avoid breastfeeding while receiving Proleukin (aldesleukin). We don’t know if this medication can pass into human breast milk, but there’s a risk of serious harm to nursing infants if it does. Because of this, you should talk with your provider about other ways to feed your baby during treatment.
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                    warings-icon

                    What are the risks and warnings for Proleukin (aldesleukin)?

                    Proleukin (aldesleukin) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

                    risk-warning

                    Capillary leak syndrome

                    • Risk factors: Heart problems | Lung problems | Kidney problems | Liver problems

                      Proleukin (aldesleukin) can cause a rare, but life-threatening side effect called capillary leak syndrome (CLS). This is a condition where fluids and proteins leak out of the blood vessels into surrounding tissues. In serious cases, CLS can result in complications such as sudden drop in blood pressure, chest pain, heart attack, and breathing problems.

                      Because of the risk of CLS, you’ll only receive Proleukin (aldesleukin) at a facility with trained medical staff who can give you emergency treatment in case you experience CLS. Your provider will check your vital signs and other labs before you start Proleukin (aldesleukin) and regularly during treatment. If you develop CLS, your provider might need to stop Proleukin (aldesleukin) to treat CLS symptoms. Let your provider know if you experience any signs of symptoms of CLS like changes in your amount of urine, trouble breathing, or confusion.

                      risk-warning

                      Serious infections

                      • Risk factors: Current infections | Indwelling central lines

                        Proleukin (aldesleukin) can raise your risk of getting a serious infection. Sometimes, this can lead to complications like sepsis or bacterial endocarditis. If you currently have an infection, your healthcare provider will likely treat it before you start Proleukin (aldesleukin). They might also give your antibiotics to prevent infections, especially if you have a central line. Let your provider know if you experience any signs or symptoms of a new infection like a fever, chills, stuffy nose, cough, ear or sinus pain, pain while urinating, or wounds that won't heal.

                        risk-warning

                        Central nervous system problems

                        • Risk factors: Seizures | Cancer that has spread to the brain

                          Proleukin (aldesleukin) can cause damage to your central nervous system (CNS). This can result in side effects such as trouble thinking clearly, vision problems, agitation, and movement or speech problems. CNS problems can go away after you stop Proleukin (aldesleukin), but sometimes they can become permanent. If you notice symptoms of CNS problems are, let your provider know because they might ask you to stop Proleukin (aldesleukin) treatment.

                          risk-warning

                          Serious stomach problems

                          Proleukin (aldesleukin) can cause serious stomach problems like nausea, vomiting, diarrhea, especially for people receiving higher doses of the medication. If your symptoms are mild, your healthcare provider can recommend ways for you to manage them such, as with anti-nausea and anti-diarrheal medications. But if you have more serious symptoms, like dark and tarry stool or stomach pains that don't go away, then your provider might ask you to stop Proleukin (aldesleukin).

                          risk-warning

                          High blood sugar

                          Proleukin (aldesleukin) can cause high blood sugar levels, sometimes leading to diabetes. If you already have high blood sugar levels, your provider will check on your labs more often during treatment. If needed, they might adjust the doses of your blood sugar medications. Let your healthcare provider know right away if you experience symptoms of dangerously high blood sugar levels, such feeling very thirsty or confused, urinating more frequently, and sweet smelling breath; you might need more urgent medical attention.

                          risk-warning

                          Thyroid gland problems

                          Proleukin (aldesleukin) can cause thyroid gland problems including hypothyroidism. Hypothyroidism usually happens 1 to 4 months after starting treatment with Proleukin (aldesleukin). Symptoms of thyroid gland problems can include weight loss or weight gain, feeling nervous or anxious, depression, eye or neck swelling, feeling hot or cold, sweating, or changes in menstruation. Let your healthcare provider know if you have symptoms of thyroid gland problems as they may need to start you on thyroid replacement medication in some cases.

                          risk-warning

                          Autoimmune or inflammatory disorders

                          Proleukin (aldesleukin) can cause autoimmune or inflammatory disorders to worsen. This can include conditions like Crohn's disease, thyroiditis, diabetes, and myasthenia gravis. Let your healthcare provider know if you have a history of an autoimmune or inflammatory disorder.

                          risk-warning

                          Liver problems

                          • Risk factors: Taking other medications that can cause liver damage

                            Proleukin (aldesleukin) can cause damage to the liver. This risk is higher if you are also taking other medications that can harm the liver. If you experience serious liver problems, your healthcare provider might need to stop your treatment with Proleukin (aldesleukin). Let your healthcare provider know right away if you have symptoms of liver problems like dark colored urine, lowered appetite, tiredness, stomach pain, or yellowing of the skin or eyes.

                            risk-warning

                            Kidney problems

                            • Risk factors: Taking other medications that can cause kidney damage

                              Proleukin (aldesleukin) can cause damage to the kidneys. This risk is higher if you are also taking other medications that can harm the kidneys or you already have kidney problems. If you experience serious kidney problems, your healthcare provider might need to stop Proleukin (aldesleukin). Let your care team know right away if you have symptoms of kidney problems like being unable to urinate, urinating less frequently or in smaller amounts, blood in your urine, or swelling in your feet or hands.

                              risk-warning

                              Severe skin reactions

                              Proleukin (aldesleukin) can cause skin problems, including a skin reaction called bullous pemphigoid. In rare cases, it can cause severe skin reactions like Stevens-Johnson syndrome (SJS), which can be life-threatening. Tell your provider immediately if you develop painful blisters, skin wounds, peeling skin, mouth sores, or red irritated eyes as these are signs of a serious skin reaction that requires medical attention.

                              risk-warning

                              Harm to an unborn baby

                              Proleukin (aldesleukin) can cause harm to an unborn baby. If you're a female who’s able to become pregnant, your provider might check to see if you’re pregnant before you start treatment. Females who are able to become pregnant should use effective birth control while receiving Proleukin (aldesleukin). Let your provider know right away if you or your partner become pregnant during this time.

                              dosage

                              Proleukin (aldesleukin) dosage forms

                              Typical dosing for Proleukin (aldesleukin)

                              The dose of Proleukin (aldesleukin) is given in international units (IU). Your healthcare provider will determine the dose based on your body weight.

                              You'll receive Proleukin (aldesleukin) in the hospital setting. Usually, you'll go through 2 cycles of treatment, with a 9-day break in between the cycles.

                              • Cycle 1 (Days 1 to 5): The typical dose is 600,000 IU/kg infused into the veins every 8 hours for a maximum of 14 doses.

                              • Break (Days 6 to 14): No treatment.

                              • Cycle 2 (Days 15 to 19): The typical dose is 600,000 IU/kg infused into the veins every 8 hours for a maximum of 14 doses.

                              interactions

                              Interactions between Proleukin (aldesleukin) and other drugs

                              Proleukin (aldesleukin) may interact with certain medications or supplements. Always let your doctor and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking. The list below does not include all possible drug interactions with Proleukin (aldesleukin). Please note that only the generic name of each medication is listed below.

                              Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

                              Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

                              Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

                              contraindications-icon

                              Proleukin (aldesleukin) contraindications

                              Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Proleukin (aldesleukin) will not be safe for you to take.

                              • Having an organ allograft

                              • Serious problems to any organ, including heart, lungs, kidneys, liver, or nervous system

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                              References

                              Best studies we found

                              American Cancer Society. (2019). Cytokines and their side effects.

                              Clinigen Limited. (2023). Proleukin- aldesleukin injection, powder, lyophilized, for solution [package insert]. DailyMed.

                              Genetic and Rare Diseases Information Center. (2023). Systemic capillary leak syndrome.

                              View All References (2)

                              Hamnvik, O. R., et al. (2011). Thyroid dysfunction from antineoplastic agents. Journal of the National Cancer Institute.

                              National Cancer Institute. (n.d.). Cytokines as therapy.

                              GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.
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