Proleukin

Proleukin is a prescription medicine used to treat kidney cancer that has spread, known as metastatic renal cell carcinoma (metastatic RCC).  It is also used to treat adults with a type of skin cancer known as metastatic melanoma.

Proleukin is used for the treatment of adults with metastatic renal cell carcinoma (metastatic RCC). Proleukin is used for the treatment of adults with metastatic melanoma.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Novartis Pharmaceuticals Corporation

Proleukin can cause serious side effects. See "Black Box Warning" and "Drug Precautions".

Common side effects of Proleukin are:

• nausea
• vomiting
• loss of appetite
• drowsiness
• weakness
• general feeling of being unwell (malaise)
• headache
• diarrhea
• dry skin

This is not a complete list of Proleukin side effects. Ask your doctor for more information.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• corticosteroids (hydrocortisone, methylprednisolone, prednisone)
• beta blockers (such as metoprolol)
• interferon alfa
• tamoxifen
• indomethacin
• aminoglycoside antibiotics (such as gentamicin)
• methotrexate and other anti-cancer medicines
• diphenhydramine (Benadryl)
• carbamazepine
• medicines for sleep or anxiety (such as alprazolam, diazepam, or zolpidem)
• muscle relaxants
• narcotic pain relievers (such as codeine)
• isoniazid
• theophylline
• tricyclic antidepressants (such as amitriptyline)

This is not a complete list of Proleukin drug interactions. Ask your doctor or pharmacist for more information.

Proleukin may make you drowsy. Do not drive a vehicle or operate machinery until you know how this medicine affects you.

Proleukin may lower blood cells required for your body to fight infection. Avoid people with known infection. Keep your hands away from your face and wash your hands often.

Proleukin may lower blood cells that are needed for blood clotting. Tell your doctor if you have unusual bruising, bleeding, or blood in stool.

Talk to your doctor before receiving any vaccination. Avoid vaccinations containing live viruses.

Do not take this medication if you are allergic to any of its active or inactive ingredients.

Do not take Proleukin if you have:

• hear arrhythmias (irregular rate or rhythm)
• chest pain or have had a heart attack
• kidney failure requiring dialysis (process of filtering your blood)
• had a coma or toxic psychosis
• seizures
• bowel ischemia (lack of oxygen to the intestines)
• bowel perforation (holes in the intestines)
• GI (stomach or intestinal) bleeding requiring surgery

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Proleukin there are no specific foods that you must exclude from your diet when receiving Proleukin.

Before receiving Proleukin tell your doctor about all of your medical conditions including if you:

• are allergic to Proleukin 
• have or have had heart, lung, brain, kidney, liver or autoimmune disease
• have an infection
• have epilepsy
• have high blood calcium levels (hypercalcemia)
• are pregnant or breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Proleukin is excreted in human breast milk or if it will harm your nursing baby.

Proleukin is given by injection into a vein (intravenous (IV) infusion) by a health care professional in a medical setting (hospital, clinic or doctor's office). This medicine is usually given over 15 minutes every 8 hours for 5 days in a row. After a rest period, another 5-day treatment is given.

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

If Proleukin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Keep all infusion and laboratory appointments. It is important to receive all scheduled Proleukin doses. Laboratory and medical test will be performed to monitor your response to the medicine.

WARNINGS

Therapy with Proleukin for injection should be restricted to patients with normal cardiac and pulmonary functions as defined by thallium stress testing and formal pulmonary function testing. Extreme caution should be used in patients with a normal thallium stress test and a normal pulmonary function test who have a history of cardiac or pulmonary disease.

Proleukin should be administered in a hospital setting under the supervision of a qualified physician experienced in the use of anticancer agents. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available.

Proleukin administration has been associated with capillary leak syndrome (CLS) which is characterized by a loss of vascular tone and extravasation of plasma proteins and fluid into the extravascular space. CLS results in hypotension and reduced organ perfusion which may be severe and can result in death.CLS may be associated with cardiac arrhythmias (supraventricular and ventricular), angina, myocardial infarction, respiratory insufficiency requiring intubation, gastrointestinal bleeding or infarction, renal insufficiency, edema, and mental status changes.

Proleukin treatment is associated with impaired neutrophil function (reduced chemotaxis) and with an increased risk of disseminated infection, including sepsis and bacterial endocarditis. Consequently, preexisting bacterial infections should be adequately treated prior to initiation of Proleukin therapy. Patients with indwelling central lines are particularly at risk for infection with gram positive microorganisms. Antibiotic prophylaxis with oxacillin, nafcillin, ciprofloxacin, or vancomycin has been associated with a reduced incidence of staphylococcal infections.

Proleukin administration should be withheld in patients developing moderate to severe lethargy or somnolence; continued administration may result in coma.