Aldesleukin, Injection

________________________________________________________________________

KEY POINTS

• This medicine is given by IV to treat advanced kidney or skin cancer.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This is a very strong medicine that can cause heart problems, breathing problems, stomach or kidney problems, swelling, or mood or behavior changes. It can also cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: antineoplastic (anticancer)

Generic and brand names: aldesleukin, injection; interleukin-2; IL-2; Proleukin

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat advanced kidney or skin cancer that has spread to other parts of your body.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blockage in the intestines, Crohn's disease, or ulcerative colitis
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection
• An autoimmune disease such as lupus, scleroderma, or rheumatoid arthritis
• Diabetes
• Heart disease, a heart attack, or an irregular heartbeat
• Kidney disease requiring dialysis
• Liver disease
• Lung disease
• Myasthenia gravis
• Seizures
• Serious skin conditions
• Thyroid problems

Tell your provider if you have any kind of infection or fever.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Infusions are given by your healthcare provider. You will be closely monitored while you are receiving this medicine. This medicine is usually given as 15-minute IV infusions every 8 hours for a total of 14 doses. After 9 days without this medicine, another 14 doses are given to complete a 28-dose course. Some doses may not be given, depending on how severe your side effects are. If this medicine is helping you, another course of injections may be given after 7 weeks.

What should I watch out for?

Before you receive this medicine, you will have heart, lung, and blood tests. This is a very strong medicine. Only healthcare providers experienced with this drug should prescribe it. It should only be given in a clinic or hospital where you can be monitored closely. Some side effects can be detected only by tests done regularly during treatment. Your healthcare provider will monitor your condition with these tests. Keep all appointments. Be sure you understand the risks and benefits of this medicine before starting treatment.

This medicine may rarely cause a serious or life-threatening problem called capillary leak syndrome (CLS). CLS may lead to low blood pressure and damage your organs. It may also lead to an irregular heartbeat, chest pain, heart attack, breathing problems, bleeding in the stomach, kidney problems, swelling, or mood or behavior changes. Talk with your healthcare provider about this.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first.

If you feel unusually tired or sleepy while receiving this medicine, contact your healthcare provider right away.

This medicine may make you dizzy or cause confusion. Be careful in everyday activities, and do not drive or operate machinery unless you are fully alert and clearheaded.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, X-rays, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine. Some people have had serious reactions to contrast dye within several weeks or months of receiving this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Black tarry or red bowel movements; bloody vomit; unexplained bruising or bleeding; irregular, fast, or slow heartbeat; chest pain; trouble breathing; yellowing of your eyes or skin; dark urine; light-colored bowel movements; unexplained loss of appetite; severe stomach pain, nausea, vomiting, or diarrhea; fever; cough; sore throat; mouth sores; severe dizziness or fainting; severe tiredness or weakness; severe drowsiness; unexplained confusion, or irritability; depression; hallucinations (seeing or hearing things that are not there); severe skin redness, blistering, or peeling skin; sudden weight gain; swelling of the feet and legs or any unexplained swelling; decreased urination or trouble urinating; problems with vision, speech, or balance; seizures.

Other: Mild anxiety, trouble sleeping, pain at injection site, dizziness, drowsiness, chills, nausea, vomiting, or diarrhea.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Alpha blockers such as doxazosin (Cardura) and prazosin (Minipress)
• Amphotericin b (Abelcet, AmBisome, Amphotec)
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antibiotics such as amikacin, gentamicin, levofloxacin (Levaquin), tobramycin, and vancomycin (Vancocin)
• Antihistamines such as cetirizine (Zyrtec), chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), fexofenadine (Allegra), and loratadine (Alavert, Claritin)
• Antipsychotic medicines such as chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), olanzapine (Zyprexa), perphenazine, prochlorperazine (Compro), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, and sotalol (Betapace, Sorine)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Calcium channel blockers such as diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as asparaginase (Erwinaze), carboplatin, cisplatin, dacarbazine, doxorubicin (Doxil), interferon-alfa, and tamoxifen
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• HIV medicines such as cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), and stavudine (Zerit)
• Live vaccines
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Narcotic pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), and oxycodone/acetaminophen (Percocet, Roxicet)
• Nausea medicines such as dimenhydrinate (Dramamine) and promethazine
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Sleeping pills such as butabarbital (Butisol), flurazepam, phenobarbital, temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)

Do not drink alcohol while taking this medicine without your healthcare provider’s approval.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.