Proleukin

Proleukin (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. Proleukin (Aldesleukin) 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.

Proleukin (Aldesleukin) will be injected by a doctor or by someone under direct supervision of a doctor in a hospital. The recommended dose of Proleukin (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 Proleukin (Aldesleukin) is required, and it is always given in a hospital or similar setting with access to sterile equipment for preparation.

It is important Proleukin (Aldesleukin) be given exactly as recommended by your doctor. If you miss an appointment to receive Proleukin (Aldesleukin), contact your doctor as soon as possible to reschedule your appointment.

As well as attacking cancer cells, Proleukin (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 Proleukin (Aldesleukin)?"

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.

Injection
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 Proleukin (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.

Do not use Proleukin (Aldesleukin) if you:

• are allergic to Proleukin (Aldesleukin), interleukin-2, or any of the ingredients of the medication
• have experienced repetitive or hard-to-control seizures after treatment with Proleukin (Aldesleukin)
• have had abnormal lung function tests
• have had Proleukin (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 Proleukin (Aldesleukin) treatment
• have had stomach bleeding requiring surgery after Proleukin (Aldesleukin) treatment

There may be an interaction between Proleukin (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 Proleukin (Aldesleukin). 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.

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 Proleukin (Aldesleukin).

Autoimmune conditions: Proleukin (Aldesleukin) 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 Proleukin (Aldesleukin).

Blood clotting: Proleukin (Aldesleukin) 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 Proleukin (Aldesleukin). If you experience any changes in thinking, movement or mood, contact your doctor immediately.

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

Drowsiness/reduced alertness: Proleukin (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 Proleukin (Aldesleukin) affects you.

Fertility: Temporary or permanent sterility may occur with the use of Proleukin (Aldesleukin).

Heart conditions: Proleukin (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: Proleukin (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 Proleukin (Aldesleukin). 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 Proleukin (Aldesleukin) to build up in the body, causing side effects. Proleukin (Aldesleukin) 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 Proleukin (Aldesleukin) with blood tests.

Liver function: Proleukin (Aldesleukin) 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 Proleukin (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: Proleukin (Aldesleukin) can cause low blood pressure: If you experience severe dizziness, especially when standing from a lying or sitting position, contact your doctor.

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

Skin reactions: Proleukin (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 Proleukin (Aldesleukin) by pregnant women. Proleukin (Aldesleukin) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Proleukin (Aldesleukin), contact your doctor immediately.

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

Children: The safety and effectiveness of Proleukin (Aldesleukin) have not been established for use by children.

Seniors: Seniors may be at higher risk of experiencing the side effects of Proleukin (Aldesleukin).