Alglucosidase Alfa (Intravenous Route)

    Alglucosidase Alfa (Intravenous Route)

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    Description and Brand Names of Alglucosidase Alfa (Intravenous Route)

    US Brand Name

    1. Lumizyme
    2. Myozyme

    Descriptions

    Alglucosidase alfa injection is an enzyme that treats Pompe disease, which is also called glycogen storage disease type II. Alglucosidase alfa contains a human enzyme called acid alpha-glucosidase. This enzyme helps with the digestion and absorption of glycogen. People with Pompe disease are not able to make enough of this enzyme.

    The Lumizymeâ„¢ form of this medicine is only available under a special restricted distribution program called Lumizymeâ„¢ ACE (Alglucosidase alfa Control and Education) program.

    This medicine is available only with your doctor’s prescription.

    This product is available in the following dosage forms:

    • Powder for Solution

    Before Using Alglucosidase Alfa (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

    Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of alglucosidase alfa injection in children.

    Geriatric

    No information is available on the relationship of age to the effects of alglucosidase alfa injection in the geriatric population.

    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:

    • Breathing problems or
    • Cardiac hypertrophy (heart is larger than normal) or
    • Heart rhythm problems (e.g., arrhythmia) or
    • Lung disease – Use with caution. May make these conditions worse.

    Proper Use of Alglucosidase Alfa (Intravenous Route)

    A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

    This medicine must be given slowly, so the needle will remain in place for a few hours. You may also receive medicines to help prevent possible allergic reactions to the injection.

    Precautions

    It is very important that your doctor check the progress of you or your child 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 chest pain; fever; chills; itching; hives or a rash; a fast heartbeat; flushing of the face; dizziness, fainting, or lightheadedness; trouble with breathing; or swelling of the face, tongue, and throat within a few hours after it is given. Check with your doctor or nurse right away if you or your child have any of these symptoms.

    This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after receiving this medicine.

    Side Effects of Alglucosidase Alfa (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 or nurse immediately if any of the following side effects occur:

    More common

    1. Blue lips, fingernails, or skin
    2. body aches or pain
    3. chest discomfort or pain
    4. chills
    5. cough
    6. difficult or labored breathing
    7. difficulty with breathing
    8. difficulty with swallowing
    9. dizziness
    10. dry, red, hot, or irritated skin
    11. ear congestion
    12. fast, pounding, or irregular heartbeat or pulse
    13. feeling of warmth
    14. fever
    15. headache
    16. hives
    17. increased sweating
    18. irregular, fast, slow, or shallow breathing
    19. itching
    20. lightheadedness, dizziness, or fainting
    21. loss of voice
    22. nasal congestion
    23. pain
    24. pale skin
    25. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    26. rapid shallow breathing
    27. redness of the face, neck, arms, and occasionally, upper chest
    28. redness or pain at the catheter site
    29. runny nose
    30. shakiness in the legs, arms, hands, or feet
    31. shortness of breath
    32. skin rash
    33. slow or irregular heartbeat
    34. sneezing
    35. sore throat
    36. swollen, painful, or tender lymph glands in the neck, armpit, or groin
    37. tightness in the chest
    38. trembling or shaking of the hands or feet
    39. troubled breathing
    40. troubled breathing with exertion
    41. unusual bleeding or bruising
    42. unusual tiredness or weakness
    43. wheezing

    Less common

    1. Blood in the urine
    2. convulsions
    3. decreased urine
    4. dry mouth
    5. increased thirst
    6. loss of appetite
    7. mood changes
    8. muscle pain or cramps
    9. nausea or vomiting
    10. numbness or tingling in the hands, feet, or lips
    11. pain in the groin or genitals
    12. sharp back pain just below the ribs

    Incidence not known

    1. Blue-green to black skin discoloration
    2. blurred vision
    3. confusion
    4. dilated neck veins
    5. extreme fatigue
    6. heart stops
    7. inability to speak
    8. no breathing
    9. no pulse or blood pressure
    10. pain, redness, swelling, or sloughing of the skin at the place of injection
    11. seizures
    12. severe or sudden headache
    13. severe pain in the chest
    14. slurred speech
    15. sudden and severe weakness in the arm or leg on one side of the body
    16. sudden onset of severe breathing difficulty
    17. swelling of the face, fingers, feet, or lower legs
    18. temporary blindness
    19. unconscious
    20. weight gain

    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. Abdominal or stomach pain
    2. acid or sour stomach
    3. belching
    4. body aches or pain
    5. change in hearing
    6. congestion
    7. constipation
    8. dryness or soreness of the throat
    9. ear discomfort or pain
    10. ear drainage
    11. earache
    12. feeling of constant movement of self or surroundings
    13. general feeling of discomfort or illness
    14. heartburn
    15. hives or welts
    16. hoarseness
    17. indigestion
    18. muscle or bone pain, stiffness, or tightness
    19. muscle twitching
    20. redness of the skin
    21. redness or swelling in the ear
    22. sensation of spinning
    23. sore mouth or tongue
    24. stomach discomfort, upset, or pain
    25. stuffy nose
    26. tender, swollen glands in the neck
    27. trouble with swallowing
    28. upper abdominal or stomach pain
    29. voice changes
    30. white patches in the mouth or on the tongue

    Less common

    1. Bloody nose
    2. sleepiness or unusual drowsiness

    Incidence not known

    1. Burning, dry, or itching eyes
    2. discharge, excessive tearing
    3. muscle spasm
    4. redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

    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.