Proleukin: Uses, Side Effects and Dosage

What PROLEUKIN is used for:

PROLEUKIN is used to treat

• A kind of kidney cancer in adults (older than 18 years of age) when your cancer has spread (also known as metastatic renal cell carcinoma).
• A kind of skin cancer in adults (older than 18 years of age) when your cancer has spread (also known as metastatic malignant melanoma).

How PROLEUKIN works:

PROLEUKIN stimulates the immune system. It helps your body produce certain types of cells in the immune system that attack and kill cancer cells.

Your body naturally produces an important protein called interleukin-2 (IL-2) that is part of the immune system. IL-2 activates certain white blood cells (called lymphocytes) to help the immune system fight against diseases and infections. PROLEUKIN is a synthetic protein that is very similar to natural IL-2. It gives your immune system more IL-2 to help find and kill cancer cells.

The ingredients in PROLEUKIN are:

Medicinal ingredient(s): Aldesleukin

Non-medicinal ingredients: Disodium hydrogen phosphate dihydrate, mannitol, sodium dodecyl sulfate and sodium dihydrogen phosphate dihydrate.

PROELUKIN comes in the following dosage forms:

22 million International Units per vial of lyophilized powder

Do not use PROLEUKIN if:

• you are allergic to aldesleukin or any other ingredients in PROLEUKIN.
• you have had an abnormal cardiac stress test or abnormal lung function test.
• you have received an organ transplant.

• you have experienced any of these side effects from an earlier treatment with PROLEUKIN:

  • fast, abnormal heart rate for longer than usual.
  • abnormal heart rate which is difficult to control.
  • chest pain.
  • fluid buildup in the sac surrounding the heart.
  • needed breathing tube for more than 72 hours.
  • poor kidney function and you required dialysis for more than 72 hours.
  • coma or mental health problems (delusions, mental confusion or changes in personality) for more than 48 hours.
  • seizures which are repetitive or difficult to control.
  • tearing or blockage of the bowel.
  • bleeding in your stomach or intestines.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take PROLEUKIN. Talk about any health conditions or problems you may have, including if you:

• have a history of heart problems and blood vessel disease (called capillary leak syndrome).
• have a history of lung problems or breathing difficulties.
• have a history of blood diseases such as low healthy blood cells in your body.
• have a history of diabetes.
• have a history of liver and kidney disease.
• have any of the following auto-immune diseases: Crohn’s disease, scleroderma, thyroiditis, inflammatory arthritis, diabetes mellitus, oculo-bulbar myasthenia gravis, crescentic IgA glomerulonephritis, cholecystitis, cerebral vasculitis, Stevens-Johnson syndrome and bullous pemphigoid.
• Have a history of thyroid gland problems.
• have received an organ transplant.
• have a history of infections. Any existing bacterial infections should be treated before the start of the treatment. Patients with indwelling central lines are particular at risk for infection.
• have a history of nervous system diseases, such as delusions, sleepiness, fainting, speech difficulties, blindness, loss of control in arms and legs, anxiety, mental confusion, seizures and coma.

• are pregnant or breastfeeding.

Other warnings you should know about:

• PROLEUKIN may cause a change in certain chemicals in the blood and damage to organs including kidneys (tumor lysis syndrome).

• PROLEUKIN may affect your ability to drive and run machinery.

• You must use the most effective methods of birth control during treatment.
• Your doctor may carry out tests before and during you are treated with PROLEUKIN. Blood tests may be carried out to test your blood cells, electrolytes, level of sugar in your blood, and your kidney and liver function. Vital signs (including temperature, pulse, blood pressure and respiration rate), weight and fluid intake and output may be monitored daily. Lung function and cardiac function should be monitored.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with PROLEUKIN:

• other anti-cancer drugs;
• steroids;
• contrast agents for medical imaging;
• drugs known to cause liver damage, kidney damage, bone marrow damage, or heart damage;
• drugs to treat mental health problems;
• blood pressure drugs.

How to take PROLEUKIN:

• PROLEUKIN will be given to you by a healthcare professional in a healthcare setting.

Usual dose:

PROLEUKIN is usually given as an IV infusion for 15 minutes every 8 hours for 5 days with a maximum of 14 doses. After 9 days of rest, another round of 14 doses may be given over 5 days for a maximum of 28 doses per course. After at least 7 weeks of rest, the 28-dose treatment plan may be repeated depending on the response to prior course of treatment.

Overdose:

Taking PROLEUKIN more often than required can cause its side effects to occur sooner and with increased severity.

Missed dose:

Your Healthcare professional will oversee your treatment and design an appropriate dosing schedule for you. If you think you missed a dose, ask your doctor or healthcare professional right away.

Possible side effects from using PROLEUKIN:

These are not all the possible side effects you may have when taking PROLEUKIN. If you experience any side effects not listed here, tell your healthcare professional.

PROLEUKIN can cause side effects. The most common side effects of PROLEUKIN are fever, chills, shivering, itching, and stomach upset. Your healthcare professional will work with you to manage these side effects.

Patients using this medication may experience serious side effects. Tell your doctor immediately if you experience any of the following:

• signs of infection such as fever and chills
• feeling weak or tired
• excessive bleeding
• irregular heartbeat
• abnormal blood pressure
• shortness of breath
• delusions
• sleepiness
• fainting
• speech difficulties
• vision problems
• loss of control in arms and legs
• anxiety
• mental confusion
• seizures
• swelling in legs or ankles
• pain in the stomach or chest
• decreased urination
• nausea or vomiting
• yellowing of eyes and skin
• diarrhea
• kidney damage
• abnormal forming of blood clot (coagulation disorder)

• changes in test results:

  • decrease in the number of blood platelets
  • increased liver enzyme levels in the blood
  • increased creatinine levels in the blood

Negative health effects are common, often serious, and sometimes deadly even for patients with normal heart, lung, liver, and brain function. Ask your doctor whether you can take PROLEUKIN.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

Storage:

Store vials of lyophilized PROLEUKIN in a refrigerator at 2^o to 8^oC. Avoid exposure to heat and light. PROLEUKIN does not contain any preservatives. The vial is for single-use only and any unused portion should be discarded according to the local waste disposal requirements for pharmaceuticals.

Do not use beyond the expiration date printed on the vial.

Reconstituted or diluted PROLEUKIN is stable for up to 48 hours at refrigerated and room temperatures, 2^o to 25^oC. This product contains no preservative.

Keep out of reach and sight of children.

If you want more information about PROLEUKIN:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website Iovance.com; or by calling 1-833-215-7566.

Date of Authorization: 2026-09-16