Pronunciation:

al-des-LOO-kin

Brand Names:

• Proleukin

Dosage Forms:

• Powder for Solution

Warnings:

Therapy should be restricted to patients with normal cardiac and pulmonary functions as defined by thallium stress testing and formal pulmonary function testing. Administration has been associated with capillary leak syndrome, which may be severe and can result in death. Treatment is also associated with impaired neutrophil function (reduced chemotaxis) and with an increased risk of disseminated infection, including sepsis and bacterial endocarditis. Administration should be withheld in patients developing moderate to severe lethargy or somnolence; continued administration may result in coma .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Interleukin

Uses of This Medicine:

Aldesleukin injection is used to treat renal cell carcinoma (a type of kidney cancer) and melanoma (a type of skin cancer) that have spread throughout the body (metastatic).

Aldesleukin is a man-made version of a substance called interleukin-2. Interleukins are produced naturally by cells in the body to help white blood cells work.

Aldesleukin causes very serious side effects in addition to its helpful effects. Some effects can be fatal. For that reason, aldesleukin injection is given only in the hospital. If severe side effects occur, which is common, treatment in an intensive care unit (ICU) may be necessary. Other effects may not be serious but may cause concern. Before you begin treatment with aldesleukin, you and your doctor should talk about the benefits this medicine will do as well as the risks of using it.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of aldesleukin injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aldesleukin injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

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.

• Betamethasone
• Cortisone
• Deflazacort
• Dexamethasone
• Hydrocortisone
• Methylprednisolone
• Paramethasone
• Prednisolone
• Prednisone
• Triamcinolone

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.

• Cisplatin
• Dacarbazine
• Interferon Alfa
• Tamoxifen

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergic skin reactions (eg, Stevens-Johnson syndrome) or
• Autoimmune disease (eg, Crohn disease) or
• Colitis (inflammation of the bowels) or
• Diabetes or
• Eye problems (eg, oculo-bulbar myasthenia gravis, optic neuritis) or
• Hyperthyroidism (overactive thyroid) or
• Hypothyroidism (underactive thyroid) or
• Hypotension (low blood pressure) or
• Seizures, history of or
• Thyroid problems (thyroiditis)—Use with caution. May make these conditions worse.

• Heart disease or
• Kidney disease or
• Liver disease or
• Lung or breathing problems or
• Nerve problems or
• Organ allograft—Should not be given in patients with these conditions.

• Infection—May decrease your body's ability to fight infection.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through an IV placed into one of your veins. It must be given slowly, so the needle will have to remain in place for at least 15 minutes.

Your doctor may also give you other medicines (eg, fever medicine) before receiving this medicine.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely and at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects..

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control to keep from getting pregnant during treatment this medicine. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine may cause a condition called capillary leak syndrome. It can cause fluid to leak from the blood vessels into your body's tissues. Call your doctor right away if you have swelling or puffiness and are urinating less often, trouble breathing, feeling of fullness, dizziness, or feeling faint.

This medicine may cause nerve problems. check with your doctor right away if you have agitation, change in consciousness, loss of consciousness, mental depression or anxiety, nightmare or unusually vivid dreams, seeing, hearing, or feeling things that are not there, trouble walking, trouble with coordination.

Check with your doctor right away if you have chills, confusion, dizziness, lightheadedness, fainting, fast heartbeat, fever, or trouble breathing. These may be signs that you have an infection.

This medicine may cause serious kidney problems (eg, kidney failure). Tell your doctor right away if you have bloody or cloudy urine, nausea, vomiting, trouble breathing, swelling of the face, feet, or lower legs, unusual tiredness or weakness, or unusual weight gain.

Aldesleukin can temporarily affect the white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Colitis (swelling of the colon or bowel) may occur with this medicine. Tell your doctor right away if you have stomach pain or tenderness, watery or bloody diarrhea, or a fever after receiving the medicine.

This medicine may cause thyroid gland problems. Check with your doctor right away if you have change in menstrual periods, decreased sexual ability in males, dry, puffy kin, feeling cold, swelling of front part of the neck, or weight gain.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Serious skin reaction, including Stevens-Johnson syndrome can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

This medicine may cause heart problems. Check with your doctor right away if you have cheat pain or discomfort, fever and chills, fast heartbeat, or trouble breathing.

This medicine may cause serious allergic reaction, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.

This medicine may cause infusion-related reactions, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you start to have a skin rash, dizziness, trouble breathing, chest tightness, swelling in your face or hands, fever or chills while you are receiving this medicine.

Before you have any medical tests, tell the medical doctor that you are receiving aldesleukin injection. This medicine may delay the side effects of iodinated contrast media.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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

Anxiety

black, tarry stools

bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine or stools

blue lips, fingernails, or skin

blurred vision

change in consciousness

chest pain, discomfort, or tightness

confusion

coughing or vomiting blood

decreased urine output

dilated neck veins

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drowsiness

fast, pounding, or irregular heartbeat or pulse

fever or chills

loss of appetite

loss of consciousness

lower back or side pain

mood or mental changes

muscle cramps in the hands, arms, feet, legs, or face

nausea

no blood pressure or pulse

numbness and tingling around the mouth, fingertips, or feet

pain or discomfort in the arms, jaw, back, or neck

painful or difficult urination

pale skin

palpitations

persistent bleeding or oozing from puncture sites, mouth, or nose

pinpoint red spots on the skin

rapid weight gain

seizures

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stomach cramps

stopping of the heart

sweating

swelling of the face, fingers, feet, or lower legs

swollen glands

tingling of the hands or feet

tremor

trouble breathing

unconsciousness

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

vomiting

Rare

Agitation

bloating

burning, numbness, tingling, or painful sensations

changes in skin color

clumsiness

constipation

delusions of persecution, mistrust, suspiciousness, or combativeness

depression

dry, shriveled appearance of skin on the hands, lower legs, or feet

heartburn

heart murmur

hostility

indigestion

irritability

lethargy

low body temperature

muscle twitching

pains in stomach, side, or abdomen, possibly radiating to the back

severe stomach pain, cramping, or burning

shivering

slow or irregular heartbeat

stupor

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area

unsteadiness or awkwardness

vomiting of blood or material that looks like coffee grounds

weak or feeble pulse

weakness in the arms, hands, legs, or feet

yellow eyes or skin

Incidence not known

Back pain

blistering, peeling, or loosening of the skin

dark urine

difficulty swallowing

hallucinations

hives, itching skin rash

joint or muscle pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

nerve pain

nervousness

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red irritated eyes

red skin lesions, often with a purple center

sensitivity to heat

stiff neck

stroke

trouble sleeping

upper right abdominal or stomach pain

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

General feeling of discomfort or illness

lack or loss of strength

sneezing

stuffy or runny nose

swelling or inflammation of the mouth

Incidence not known

Burning feeling in chest or stomach

muscular tenderness or wasting

tenderness in the stomach area

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.