Agalsidase Beta (Intravenous Route)

    Agalsidase Beta (Intravenous Route)

    10
    0
    SHARE

    Description and Brand Names of Agalsidase Beta (Intravenous Route)

    US Brand Name

    1. Fabrazyme

    Descriptions

    Agalsidase beta is used to treat Fabry disease which is an inherited disease caused by the lack of an enzyme called alpha-galactosidase A, in the body. This enzyme is necessary for your body.

    Agalsidase beta is available only with your doctor’s prescription.

    This product is available in the following dosage forms:

    • Powder for Solution

    Before Using Agalsidase Beta (Intravenous 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

    Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of agalsidase beta in children with use in other age groups.

    Geriatric

    Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of agalsidase beta in the elderly with use in other age groups.

    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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

    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:

    • Heart problems – May be at a higher risk of severe complications from infusion reaction.

    Proper Use of Agalsidase Beta (Intravenous Route)

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For Fabry disease:

      • For injection dosage form:

        • Adults – The dose is based on body weight and must be determined by your doctor. The usual dose is 1 mg per kilogram (kg) of body weight, injected slowly into a vein. The dose may be repeated once every 2 weeks.
        • Children – Use and dose must be determined by your doctor.

    Missed Dose

    Call your doctor or pharmacist for instructions.

    Precautions

    It is important that your doctor monitor your progress while you are receiving agalsidase beta to make sure that the medicine is working properly.

    It is important to take medicine for treatment of infusion reaction prior to receiving your infusion.

    Importance of receiving agalsidase beta in health care facility with medical support for severe infusion reactions.

    Side Effects of Agalsidase Beta (Intravenous 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 immediately if any of the following side effects occur:

    More common

    1. Blurred vision
    2. chest pain or discomfort
    3. confusion
    4. cough producing mucus
    5. difficulty breathing
    6. difficulty in moving
    7. dizziness;
    8. fatigue
    9. faintness or lightheadedness when getting up from a lying or sitting position suddenly
    10. feeling unusually cold shivering
    11. headache
    12. hives or welts
    13. irregular heartbeat
    14. itching
    15. joint pain
    16. muscle aching or cramping
    17. muscle pains or stiffness
    18. nervousness
    19. pain
    20. pounding in the ears
    21. redness of skin
    22. shortness of breath
    23. skin rash
    24. stomach pain
    25. sweating
    26. swelling of ankles, feet, and lower legs
    27. swollen joints
    28. tightness in chest
    29. unusual tiredness or weakness
    30. wheezing

    Incidence unknown

    1. Cloudy or bloody urine
    2. decreased cardiac output
    3. difficulty in speaking
    4. double vision
    5. feeling of constant movement of self or surroundings
    6. high blood pressure
    7. inability to move arms, legs, or facial muscles
    8. inability to speak
    9. no blood pressure or pulse
    10. partial loss of hearing
    11. pounding or rapid pulse
    12. problems with muscle control or coordination
    13. sensation of spinning
    14. shakiness and unsteady walk
    15. slow speech
    16. stopping of heart
    17. swelling of face
    18. swelling of the lip or ear
    19. throat tightness
    20. trembling
    21. unconsciousness

    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:

    More Common

    1. Acid or sour stomach
    2. belching
    3. body aches or pain
    4. body produces substance that can bind to drug making it less effective or cause side effects
    5. burning, crawling, itching, numbness, prickling, “pins and needles” , or tingling feelings
    6. congestion
    7. discouragement
    8. dryness or soreness of throat
    9. fear
    10. feeling sad or empty
    11. fever, not related to infusion
    12. heartburn
    13. hoarseness
    14. indigestion
    15. irritability
    16. lack of appetite
    17. loss of interest or pleasure
    18. nausea
    19. pain or tenderness around eyes and cheekbones
    20. paleness of skin
    21. runny nose
    22. sensation of change in temperature
    23. skeletal pain
    24. sneezing
    25. stuffy nose; swelling of testes
    26. tender, swollen glands in neck
    27. trouble concentrating
    28. trouble sleeping
    29. trouble in swallowing
    30. voice changes

    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.