Asparaginase Erwinia Chrysanthemi (Intramuscular Route)

    Asparaginase Erwinia Chrysanthemi (Intramuscular Route)

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    Description and Brand Names of Asparaginase Erwinia Chrysanthemi (Intramuscular Route)

    US Brand Name

    1. Erwinaze

    Descriptions

    Asparaginase Erwinia chrysanthemi is used together with other cancer medicines to treat a certain type of blood cancer called acute lymphoblastic leukemia (ALL). This medicine is used in patients who have had an allergic reaction to E. coli-derived asparaginase.

    Asparaginase Erwinia chrysanthemi belongs to the group of medicines known as antineoplastic agents. It interferes with the growth of the cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by this medicine, other effects will also occur. Some of these may be serious and must be reported to your doctor.

    Before you begin treatment with Erwinazeâ„¢, you and your doctor should talk about the benefits of this medicine as well as the risks of using it.

    This medicine is to be administered only by or under the immediate supervision of your doctor.

    This product is available in the following dosage forms:

    • Powder for Solution

    Before Using Asparaginase Erwinia Chrysanthemi (Intramuscular Route)

    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.

    Pediatric

    Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Erwinazeâ„¢ in children.

    Geriatric

    Appropriate studies have not been performed on the relationship of age to the effects of Erwinazeâ„¢ in the geriatric population. Safety and efficacy have not been established.

    Pregnancy

    Breastfeeding

    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.

    Drug Interactions

    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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Rotavirus Vaccine, Live

    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.

    • Adenovirus Vaccine Type 4, Live
    • Adenovirus Vaccine Type 7, Live
    • Bacillus of Calmette and Guerin Vaccine, Live
    • Influenza Virus Vaccine, Live
    • Measles Virus Vaccine, Live
    • Methotrexate
    • Mumps Virus Vaccine, Live
    • Prednisolone
    • Prednisone
    • Rubella Virus Vaccine, Live
    • Smallpox Vaccine
    • Typhoid Vaccine
    • Varicella Virus Vaccine
    • Vincristine
    • Vincristine Sulfate Liposome
    • Yellow Fever Vaccine

    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:

    • Bleeding problems caused by L-asparaginase treatment, history of or
    • Blood clotting problems caused by L-asparaginase treatment, history of or
    • Pancreatitis caused by L-asparaginase treatment, history of – Should not be given to patients with these conditions.
    • Bleeding problems or
    • Blood clotting problems or
    • Diabetes or
    • Hyperglycemia (high blood sugar) or
    • Pancreatitis (inflammation of the pancreas) – Use with caution. May make these conditions worse.

    Proper Use of Asparaginase Erwinia Chrysanthemi (Intramuscular Route)

    A doctor or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given as a shot into one of your muscles.

    Erwinazeâ„¢ is sometimes given together with other medicines. If you are receiving a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by the mouth, ask your doctor to help you plan a way to take them at the right times.

    Missed Dose

    This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

    Precautions

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

    This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have chills; fever; lightheadedness, dizziness, or fainting; fast, pounding heartbeat; swelling of the face, tongue, and throat; or trouble breathing after you receive the medicine.

    Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

    Check with your doctor right away if you start having increased thirst or hunger, increased urination, pale skin, nausea, sweating, or faintness. These may be signs that you are having problems with the amount of blood sugar in your body.

    Tell your doctor right away if you develop confusion, headache, nausea and vomiting, numbness or tingling in the arms or legs, shortness of breath, or chest pain after receiving this medicine. These may be symptoms of a serious bleeding or blood clotting problem.

    Side Effects of Asparaginase Erwinia Chrysanthemi (Intramuscular Route)

    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

    1. Cough
    2. difficulty with swallowing
    3. dizziness
    4. fast heartbeat
    5. fever
    6. hives or welts
    7. hoarseness
    8. irritation
    9. itching
    10. joint pain, stiffness, or swelling
    11. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    12. rash
    13. redness of the skin
    14. shortness of breath
    15. swelling of the eyelids, face, lips, hands, or feet
    16. tightness in the chest
    17. troubled breathing or swallowing
    18. unusual tiredness or weakness
    19. wheezing

    Less common

    1. Abdominal or stomach pain
    2. bloating
    3. blurred vision
    4. chills
    5. constipation
    6. darkened urine
    7. dry mouth
    8. flushed, dry skin
    9. fruit-like breath odor
    10. increased hunger
    11. increased thirst
    12. increased urination
    13. indigestion
    14. loss of appetite
    15. nausea
    16. pains in the chest, groin, or legs, especially calves of the legs
    17. pains in the stomach, side, or abdomen, possibly radiating to the back
    18. seizures
    19. severe headaches of sudden onset
    20. sudden loss of coordination
    21. sudden onset of shortness of breath for no apparent reason
    22. sudden onset of slurred speech
    23. sudden vision changes
    24. sweating
    25. unexplained weight loss
    26. vomiting
    27. yellow eyes or skin

    Rare

    1. Blood in the urine or stools
    2. bruising
    3. confusion
    4. coughing or vomiting blood
    5. headache
    6. numbness or tingling in the face, arms, or legs
    7. persistent bleeding or oozing from puncture sites, mouth, or nose
    8. red streaks on the skin
    9. swelling, tenderness, or pain at the injection site
    10. trouble speaking, thinking, or walking

    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:

    Less common

    1. Diarrhea

    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.