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Aldesleukin

 
  Generic Name: Aldesleukin (Al dess LEW kin)
 
  Brand Names: Proleukin  
     
   
 

What is aldesleukin?

Aldesleukin (interleukin 2) is a cancer (chemotherapeutic) medication. Aldesleukin increases certain immunological processes in the body that cause decreased growth of some types of cancer cells.

Aldesleukin is used in the treatment of metastatic renal cell carcinoma (metastatic RCC), a type of kidney cancer) and metastatic melanoma.

Aldesleukin may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about aldesleukin?

Aldesleukin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of aldesleukin including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or infection); capillary leak syndrome, a condition that may lead to heart attack, severe breathing difficulties, stomach bleeding, kidney problems, and death; severe nausea, vomiting, diarrhea, and loss of appetite; and others. Talk to your doctor about the possible side effects from treatment with aldesleukin.

What should I discuss with my healthcare provider before using aldesleukin?

Do not take aldesleukin without first talking to your doctor if you have:

  • heart disease such as irregular heartbeats, angina (chest pain), or history of heart attack;

  • lung or breathing problems;

  • kidney disease;
  • liver disease;
  • seizure disorder;

  • an infection;

  • an organ transplant;

  • central nervous system (CNS) impairment; or

  • an autoimmune or inflammatory disorder such as Crohn's disease, scleroderma, thyroid disease or thyroiditis, rheumatoid arthritis, diabetes, myasthenia gravis, Stevens-Johnson syndrome, and others.

You may not be able to take aldesleukin, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.

Aldesleukin is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not use aldesleukin without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether aldesleukin passes into breast milk. Do not take aldesleukin without first talking to your doctor if you are breast-feeding a baby.

How should I use aldesleukin?

Aldesleukin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Aldesleukin is administered by intravenous (into a vein) injection.

Your doctor will determine the correct amount and frequency of treatment with aldesleukin depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with aldesleukin to monitor progress and side effects.

Store vials of lyophilized aldesleukin in the refrigerator. Protect the vials from light and store them in a carton until time of use. Reconstituted or diluted aldesleukin is stable for up to 48 hours at refrigerated and room temperatures, 2 to 25C (36 to 77F). However, since this product contains no preservative, the reconstituted and diluted solutions should be stored in the refrigerator. Do not use any aldesleukin products beyond the expiration date printed on the vial.

What happens if I miss a dose?

Contact your doctor if you miss a dose of aldesleukin.

What happens if I overdose?

If for any reason an overdose is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Symptoms of a aldesleukin overdose may be similar to side effects caused by the medication, although often more severe.

What should I avoid while using aldesleukin?

Do not have x-rays that involve the use of contrast media (dye) without first talking to your doctor. There may be an increased risk of an allergic reaction to the dye during and for a time following treatment with aldesleukin. Aldesleukin may interact with other drugs that cause drowsiness, including antidepressants, antihistamines, pain relievers, anxiety medicines, seizure medicines, muscle relaxants, and others. Dangerous drowsiness may occur if aldesleukin is taken with any of these medications. Talk to your doctor before taking aldesleukin in combination with any other prescription or over-the-counter medicines.

Aldesleukin side effects

If you experience any of the following serious side effects from aldesleukin, contact your doctor immediately:

  • an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

  • decreased bone marrow function or blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or infection);

  • capillary leak syndrome (leaking of blood plasma and fluid from the blood vessels), a condition that may lead to heart attack, severe breathing difficulties, stomach bleeding, kidney problems, and death;

  • mood or behavior changes such as irritability, confusion, agitation, or hallucinations;

  • problems with speech, walking, or coordination;

  • severe drowsiness;

  • seizures;

  • difficulty breathing or unusual breath sounds;

  • abdominal pain or swelling;

  • swelling or fluid retention;

  • fainting or irregular heart beats;

  • severe nausea, vomiting, or diarrhea;

  • rash; or

  • new or worsening symptoms of an autoimmune or inflammatory condition.

Other, less serious side effects may be more likely to occur. Continue taking aldesleukin and talk to your doctor if you experience:

  • tiredness or weakness; or

  • diarrhea, nausea, vomiting, loss of appetite.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Aldesleukin Dosing Information

Usual Adult Dose for Renal Cell Carcinoma:

0.037 mg/kg by IV infusion every 8 hours

Infusions may be administered every 8 hours for a maximum of 14 doses. Following 9 days of rest, the schedule may be repeated for another 14 doses, to a maximum of 28 doses per course, as tolerated.


Patients should be evaluated for response approximately 4 weeks after completion of a course of therapy and again immediately prior to the scheduled start of the next treatment course. Additional courses of treatment should be given to patients only if there is some tumor shrinkage following the last course and retreatment is not contraindicated. Each treatment course should be separated by a rest period of at least 7 weeks from the date of hospital discharge.

Usual Adult Dose for Malignant Melanoma:

0.037 mg/kg by IV infusion every 8 hours

Infusions may be administered every 8 hours for a maximum of 14 doses. Following 9 days of rest, the schedule may be repeated for another 14 doses, to a maximum of 28 doses per course, as tolerated.


Patients should be evaluated for response approximately 4 weeks after completion of a course of therapy and again immediately prior to the scheduled start of the next treatment course. Additional courses of treatment should be given to patients only if there is some tumor shrinkage following the last course and retreatment is not contraindicated. Each treatment course should be separated by a rest period of at least 7 weeks from the date of hospital discharge.

What other drugs will affect aldesleukin?

Do not have x-rays that involve the use of contrast media (dye) without first talking to your doctor. There may be an increased risk of an allergic reaction to the dye during and for a time following treatment with aldesleukin. Aldesleukin may interact with other drugs that cause drowsiness, including antidepressants, antihistamines, pain relievers, anxiety medicines, seizure medicines, muscle relaxants, and others. Dangerous drowsiness may occur if aldesleukin is taken with any of these medications. Talk to your doctor before taking aldesleukin in combination with any other prescription or over-the-counter medicines.

Side effects from aldesleukin may be increased by other medications that affect the kidneys, liver, heart, or other organ systems. Severe or irreversible reactions may occur. Do not take any other prescription or over-the-counter medications, including herbal or alternative medicine products, during treatment with aldesleukin without first talking to your doctor.

Where can I get more information?

  • Your healthcare provider may have additional information about aldesleukin that you may read.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.03. Revision Date: 4/12/2009 4:39:49 PM.;
 
 
 
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