"The U.S. Food and Drug Administration today approved Erwinaze (asparaginase Erwinia chrysanthemi) to treat patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pega"...
Elspar Consumer (continued)
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), signs of high blood sugar (such as 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.
Read the Elspar (asparaginase) Side Effects Center for a complete guide to possible side effects
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. If used in the first trimester, 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.
Additional Elspar Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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