Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

  1. Lumizyme
  2. Myozyme

Descriptions


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

This medicine is to be given only by or under the direct supervision of your doctor.

This product is available in the following dosage forms:

  • Powder for Solution

Before Using

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

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

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 disease or
  • Heart rhythm problems (eg, arrhythmia) or
  • Lung or breathing problems—Use with caution. May make these conditions worse.

Proper Use

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

The medicine must be injected slowly, so the IV will need to stay in place for 4 hours. It is usually given every 2 weeks.

Your doctor will give you other medicines (eg, allergy, fever, or steroid medicine) before you receive this medicine to help prevent unwanted effects.

Missed Dose

Call your doctor or pharmacist for instructions.

Precautions

It is very important that your doctor check your or your child's progress closely at regular visits to make sure this medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child have blurred vision, chest discomfort or tightness, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, fast heartbeat, flushing, redness of the skin, rash, itching, hoarseness, sweating, trouble breathing, trouble swallowing, unusually warm skin, any swelling of the hands, face, or mouth, or unusual tiredness or weakness after receiving this medicine.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child start to have chest discomfort, fever, chills or shaking, confusion, difficulty swallowing, dizziness, fast heartbeat, flushing, redness of the skin, increased or decreased blood pressure, trouble breathing, itching or rash, unusually warm skin, or lightheadedness, or fainting after receiving this medicine.

Immune-mediated reactions (eg, protein in the urine, kidney problems, and skin reactions) may occur while you or your child are receiving this medicine. Check with your doctor away if you or your child have bumps and rash on the skin, cloudy or bloody urine, high blood pressure, or swelling of the face, feet, or lower legs.

Side Effects

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

Less common

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

Incidence not known

  1. Blue-green to black skin discoloration
  2. blurred vision
  3. bumps and rash on the skin
  4. cloudy urine
  5. confusion
  6. dilated neck veins
  7. extreme fatigue
  8. heart stops
  9. high blood pressure
  10. inability to speak
  11. no breathing
  12. no pulse or blood pressure
  13. pain, redness, swelling, or sloughing of the skin at the place of injection
  14. severe or sudden headache
  15. severe pain in the chest
  16. slurred speech
  17. sudden and severe weakness in the arm or leg on one side of the body
  18. sudden onset of severe breathing difficulty
  19. swelling of the face, fingers, feet, or lower legs
  20. temporary blindness
  21. unconscious
  22. 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. Acid or sour stomach
  2. belching
  3. body aches or pain
  4. change in hearing
  5. congestion
  6. constipation
  7. dryness or soreness of the throat
  8. ear discomfort or pain
  9. ear drainage
  10. earache
  11. feeling of constant movement of self or surroundings
  12. general feeling of discomfort or illness
  13. heartburn
  14. hoarseness
  15. indigestion
  16. muscle or bone pain, stiffness, or tightness
  17. muscle twitching
  18. redness of the skin
  19. redness or swelling in the ear
  20. sensation of spinning
  21. sore mouth or tongue
  22. stomach discomfort, upset, or pain
  23. tender, swollen glands in the neck
  24. upper abdominal or stomach pain
  25. voice changes
  26. 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.

Portions of this document last updated: May 01, 2024

Original article: https://www.mayoclinic.org/drugs-supplements/alglucosidase-alfa-intravenous-route/description/drg-20074293