Elspar

DRUG DESCRIPTION

Elspar (asparaginase) contains the enzyme L-asparagine amidohydro-lase, type EC-2, derived from Escherichia coli. Elspar (asparaginase) activity is expressed in terms of International Units according to the recommendation of the International Union of Biochemistry. One International Unit of asparaginase is defined as that amount of enzyme required to generate 1 ?mol of ammonia per minute at pH 7.3 and 37C. The specific activity of Elspar (asparaginase) is at least 225 International Units per milligram of protein. Elspar (asparaginase) is provided as a sterile, white lyophilized plug or powder. Each vial contains 10, 000 International Units of asparaginase and 80 mg of mannitol.

What are the possible side effects of asparaginase (Elspar)?

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

Even if you have received asparaginase without reaction in the past, you may have an allergic reaction to the medication when you receive it again.

Call your doctor at once if you have any of these serious side effects:

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • easy bruising or bleeding, unusual...

Read All Potential Side Effects and See Pictures of Elspar

What are the precautions when taking asparaginase (Elspar)?

Before receiving asparaginase, 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: pancreatitis, liver disease.

This drug may make you 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.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose....

Read All Potential Precautions of Elspar


Elspar Consumer (continued)

SIDE EFFECTS: Pain or swelling at the injection site, nausea, vomiting, stomach cramps, loss of appetite, headache, lack of energy, or drowsiness may occur. Nausea and vomiting can be severe, and in some cases you may need anti-nausea drugs. Not eating before your treatment may help relieve nausea and vomiting. Changes in diet, such as eating several small meals, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: severe stomach pain with nausea/vomiting, mental/mood changes, tremor, muscle stiffness, joint pain, swelling of hands/feet/lower legs, yellowing of the eyes/skin, unusual bleeding/bruising (such as nose bleeds, black or bloody stools), unusual thirst, frequent urination, change in the amount of urine.

Get medical help right away if any of these rare but very serious side effects occur: abnormally high fever, vision changes, fainting, severe headache, severe dizziness, seizures, chest pain.

This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, chills, sores in mouth or on lips, or persistent sore throat.

A very serious allergic reaction to this drug is unlikely. However, get medical help right away 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: Before receiving asparaginase, 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: pancreatitis, liver disease.

This drug may make you 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.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of infections.

Use caution with sharp objects like razors or nail cutters and avoid activities such as contact sports to lower the chance of getting cut, bruised or injured.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication should be used only when clearly needed during pregnancy. Asparaginase may cause harm to an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. Women of child-bearing age should use an effective form of birth control while using this medication. Discuss the risks, benefits and any other concerns with your doctor.

It is not known whether asparaginase passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Elspar Patient Information Including Side Effects

Brand Names: Elspar

Generic Name: asparaginase (Pronunciation: as PAR a jin ase)

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

What is asparaginase (Elspar)?

Asparaginase is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

Asparaginase is used to treat acute lymphocytic lymphoma.

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

What are the possible side effects of asparaginase (Elspar)?

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

Even if you have received asparaginase without reaction in the past, you may have an allergic reaction to the medication when you receive it again.

Call your doctor at once if you have any of these serious side effects:

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • easy bruising or bleeding, unusual weakness;
  • fever, chills, body aches, flu symptoms;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • increased thirst or urination;
  • agitation, hallucinations, seizure (convulsions);
  • tremors, muscle stiffness; or
  • urinating more or less than usual, or not at all.

Less serious side effects may include:

  • mild skin rash or itching;
  • depression, drowsiness;
  • swelling in your hands, ankles, or feet;
  • nausea, vomiting, loss of appetite, weight loss;
  • stomach cramps; or
  • headache, feeling tired or irritable.

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 asparaginase (Elspar)?

Do not receive this medication if you are allergic to asparaginase or pegaspargase (Oncaspar), or if you have a history of liver disease or pancreas problems. Tell your doctor about all other cancer medications you are receiving.

Get emergency medical help if you think you have received too much of this medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Even if you have received asparaginase without reaction in the past, you may have an allergic reaction to the medication when you receive it again.

Call your doctor at once if you have any of the following side effects during your treatment with asparaginase:

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • easy bruising or bleeding, unusual weakness;
  • fever, chills, body aches, flu symptoms;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • agitation, hallucinations, seizure (convulsions); or
  • urinating less than usual or not at all.

Asparaginase is highly toxic and both the powder and solution must be handled with care. Avoid inhaling vapors from the medicine, or allowing the medicine to come into contact with your skin, eyes, nose, or mouth. If the medicine gets on your skin, wash the area right away with soap and water. If the medicine gets into your eyes, rinse them for at least 15 minutes with water, saline, or other irrigating solution and seek emergency medical attention.

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

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