Proleukin

DRUG DESCRIPTION

PROLEUKIN® (aldesleukin) for injection, a human recombinant interleukin-2 product, is a highly purified protein with a molecular weight of approximately 15,300 daltons. The chemical name is des-alanyl-1, serine-125 human interleukin-2. PROLEUKIN (aldesleukin) , a lymphokine, is produced by recombinant DNA technology using a genetically engineered E. colistrain containing an analog of the human interleukin-2 gene. Genetic engineering techniques were used to modify the human IL-2 gene, and the resulting expression clone encodes a modified human interleukin-2. This recombinant form differs from native interleukin-2 in the following ways: a) PROLEUKIN (aldesleukin) is not glycosylated because it is derived from E. coli ; b) the molecule has no N-terminal alanine; the codon for this amino acid was deleted during the genetic engineering procedure; c) the molecule has serine substituted for cysteine at amino acid position 125; this was accomplished by site specific manipulation during the genetic engineering procedure; and d) the aggregation state of PROLEUKIN (aldesleukin) is likely to be different from that of native interleukin-2.

The in vitro biological activities of the native nonrecombinant molecule have been reproduced with PROLEUKIN (aldesleukin) .1,2

PROLEUKIN (aldesleukin) is supplied as a sterile, white to off-white, lyophilized cake in single-use vials intended for intravenous (IV) administration. When reconstituted with 1.2 mL Sterile Water for Injection, USP, each mL contains 18 million IU (1.1 mg) PROLEUKIN (aldesleukin) , 50 mg mannitol, and 0.18 mg sodium dodecyl sulfate, buffered with approximately 0.17 mg monobasic and 0.89 mg dibasic sodium phosphate to a pH of 7.5 (range 7.2 to 7.8). The manufacturing process for PROLEUKIN (aldesleukin) involves fermentation in a defined medium containing tetracycline hydrochloride. The presence of the antibiotic is not detectable in the final product. PROLEUKIN (aldesleukin) contains no preservatives in the final product.

PROLEUKIN (aldesleukin) biological potency is determined by a lymphocyte proliferation bioassay and is expressed in International Units (IU) as established by the World Health Organization 1st International Standard for Interleukin-2 (human). The relationship between potency and protein mass is as follows:

18 million (18 x 106) IU PROLEUKIN (aldesleukin) = 1.1 mg protein

What are the possible side effects of aldesleukin (Proleukin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe drowsiness;
  • feeling like you might pass out;
  • chest pain, fast or pounding heartbeats;
  • runny or stuffy nose, cough, rapid breathing and heart rate, trouble breathing, swelling and pain in any part of your body;
  • problems with vision, speech,...

Read All Potential Side Effects and See Pictures of Proleukin »

What are the precautions when taking aldesleukin (Proleukin)?

See also Warning section.

Before using aldesleukin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, heart disease (e.g., fast/irregular heartbeat, recent heart attack, angina), liver disease, lung disease, stomach problems (e.g., ischemic bowel, perforation, bleeding ulcers), high levels of calcium (hypercalcemia), history of organ transplant, seizures.

This medication may worsen certain types of immune system disorders (autoimmune and inflammatory type). Before using...

Read All Potential Precautions of Proleukin »

What are the possible side effects of aldesleukin (Proleukin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe drowsiness;
  • feeling like you might pass out;
  • chest pain, fast or pounding heartbeats;
  • runny or stuffy nose, cough, rapid breathing and heart rate, trouble breathing, swelling and pain in any part of your body;
  • problems with vision, speech,...

Read All Potential Side Effects and See Pictures of Proleukin »

What are the precautions when taking aldesleukin (Proleukin)?

See also Warning section.

Before using aldesleukin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, heart disease (e.g., fast/irregular heartbeat, recent heart attack, angina), liver disease, lung disease, stomach problems (e.g., ischemic bowel, perforation, bleeding ulcers), high levels of calcium (hypercalcemia), history of organ transplant, seizures.

This medication may worsen certain types of immune system disorders (autoimmune and inflammatory type). Before using...

Read All Potential Precautions of Proleukin »

What are the possible side effects of aldesleukin (Proleukin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe drowsiness;
  • feeling like you might pass out;
  • chest pain, fast or pounding heartbeats;
  • runny or stuffy nose, cough, rapid breathing and heart rate, trouble breathing, swelling and pain in any part of your body;
  • problems with vision, speech,...

Read All Potential Side Effects and See Pictures of Proleukin »

What are the precautions when taking aldesleukin (Proleukin)?

See also Warning section.

Before using aldesleukin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, heart disease (e.g., fast/irregular heartbeat, recent heart attack, angina), liver disease, lung disease, stomach problems (e.g., ischemic bowel, perforation, bleeding ulcers), high levels of calcium (hypercalcemia), history of organ transplant, seizures.

This medication may worsen certain types of immune system disorders (autoimmune and inflammatory type). Before using...

Read All Potential Precautions of Proleukin »

What are the possible side effects of aldesleukin (Proleukin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe drowsiness;
  • feeling like you might pass out;
  • chest pain, fast or pounding heartbeats;
  • runny or stuffy nose, cough, rapid breathing and heart rate, trouble breathing, swelling and pain in any part of your body;
  • problems with vision, speech,...

Read All Potential Side Effects and See Pictures of Proleukin »

What are the precautions when taking aldesleukin (Proleukin)?

See also Warning section.

Before using aldesleukin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, heart disease (e.g., fast/irregular heartbeat, recent heart attack, angina), liver disease, lung disease, stomach problems (e.g., ischemic bowel, perforation, bleeding ulcers), high levels of calcium (hypercalcemia), history of organ transplant, seizures.

This medication may worsen certain types of immune system disorders (autoimmune and inflammatory type). Before using...

Read All Potential Precautions of Proleukin »


Proleukin Consumer (continued)

SIDE EFFECTS: See also Warning section.

Fever, chills, stomach upset, dry skin, muscle stiffness, diarrhea, mouth sores, dizziness, drowsiness, headache, weight gain, nausea, vomiting, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor immediately if any of these unlikely but serious side effects occur: swollen belly, muscle pain/weakness, severe tiredness, confusion, difficulty speaking, trouble walking, vision changes (including temporary blindness), mental/mood changes (e.g., depression, agitation, hallucinations), unusual bleeding/bruising, swelling hands/feet, sudden weight gain, shortness of breath, thirst, flushing, rapid breathing.

Tell your doctor immediately if any of these rare but very serious side effects occur: fast heartbeat, yellowing eyes/skin, dark urine, vomit that looks like coffee grounds.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest/jaw/left arm pain, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.

Before using aldesleukin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, heart disease (e.g., fast/irregular heartbeat, recent heart attack, angina), liver disease, lung disease, stomach problems (e.g., ischemic bowel, perforation, bleeding ulcers), high levels of calcium (hypercalcemia), history of organ transplant, seizures.

This medication may worsen certain types of immune system disorders (autoimmune and inflammatory type). Before using this medication, tell your doctor or pharmacist if you have any of the following disorders: a certain bowel disease (Crohn's disease), a certain connective tissue disease (scleroderma), thyroid disorders, arthritis, diabetes, a certain muscle/nerve disease (myasthenia gravis), a certain kidney disorder (glomerulonephritis), gallbladder problems (cholecystitis), a certain disease of blood vessels in the brain (cerebral vasculitis).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

If you are scheduled to have any X-ray or scanning procedure using injectable dye (e.g., iodinated contrast), tell your doctor that you are using this medication.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at a greater risk for kidney effects or shortness of breath while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Women who may become pregnant should use an effective form of birth control while using this medication. Discuss the use of birth control and the risks and benefits of using this medication with your doctor.

It is unknown if this medication passes into breast milk. Because of possible harm to a nursing infant, breast-feeding is not recommended while using this medication. Consult your doctor before breast-feeding.


Proleukin Patient Information Including Side Effects

Brand Names: Proleukin

Generic Name: aldesleukin (Pronunciation: AL des LOO kin)

  • What is aldesleukin (Proleukin)?
  • What are the possible side effects of aldesleukin (Proleukin)?
  • What is the most important information I should know about aldesleukin (Proleukin)?
  • What should I discuss with my healthcare provider before receiving aldesleukin (Proleukin)?
  • How is aldesleukin given (Proleukin)?
  • What happens if I miss a dose (Proleukin)?
  • What happens if I overdose (Proleukin)?
  • What should I avoid while receiving aldesleukin (Proleukin)?
  • What other drugs will affect aldesleukin (Proleukin)?
  • Where can I get more information?

What is aldesleukin (Proleukin)?

Aldesleukin is a cancer medication that interferes with tumor growth.

Aldesleukin is used to treat kidney cancer or skin cancer than has spread to other parts of the body.

Aldesleukin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of aldesleukin (Proleukin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe drowsiness;
  • feeling like you might pass out;
  • chest pain, fast or pounding heartbeats;
  • runny or stuffy nose, cough, rapid breathing and heart rate, trouble breathing, swelling and pain in any part of your body;
  • problems with vision, speech, balance, or coordination;
  • mood or behavior changes, confusion, agitation, hallucinations;
  • seizures (convulsions);
  • swelling, rapid weight gain;
  • black, bloody, or tarry stools;
  • urinating less than usual or not at all;
  • a blistering skin rash;
  • jaundice (yellowing of the skin or eyes); or
  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), nausea and vomiting, mouth sores, unusual weakness.

Less serious side effects may include:

  • mild stomach pain;
  • tired feeling;
  • drowsiness, dizziness, anxiety; or
  • diarrhea, 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.

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

You should not receive this medication if you are allergic to aldesleukin or interleukin-2, or if you have a bacterial infection, if you have received an organ transplant, or if you have recently had abnormal lung or heart function tests.

You may not be able to receive aldesleukin if prior treatment with this medication caused chest pain, irregular heart rhythm, a build-up of fluid around your heart, kidney failure, seizures, psychosis, stomach or intestinal bleeding, or if you needed a breathing tube.

Before you receive aldesleukin, tell your doctor if you have a heart disorder or history of heart attack, breathing problems, kidney or liver disease, gallbladder disease, high levels of calcium in your blood, a thyroid disorder, diabetes, seizures, mental illness, neurologic problems, or an autoimmune disorder (arthritis, Crohn's disease, scleroderma, myasthenia gravis, or skin disorder).

There are many other drugs that can interact with aldesleukin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

If you need to have any type of x-ray or other scan using a contrast agent (a dye that is used to help blood vessels, organs, and other non-bony tissues appear more clearly on the x-ray or scan), be sure the doctor knows ahead of time if you have recently received aldesleukin. Some people treated with aldesleukin or similar medication have had unusual allergic reactions to contrast agents used within weeks to several months later.

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