Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Fabrazyme

Descriptions


Agalsidase beta injection 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 used to help replace this enzyme.

This medicine is to be given only by or under the 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 have not been performed on the relationship of age to the effects of agalsidase beta injection in children younger than 2 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies have not been performed on the relationship of age to the effects of agalsidase beta injection in geriatric patients.

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—Use with caution. May be at a higher risk of severe complications from infusion reaction.

Proper Use

A nurse or other trained health professional will give you this medicine in a medical facility. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for at least 1½ hours every 2 weeks.

You or your child may also receive other medicines (eg, allergy medicine, fever medicine, steroids) before starting treatment with this medicine.

Precautions

It is very important that your doctor check your or your child's progress closely while you are receiving this medicine to make sure that it is working properly. Blood 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. Check with your doctor right away if you or your child have cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, skin rash, tightness in chest, trouble breathing, or unusual tiredness or weakness.

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 a fever, chills or shaking, chest pain, dizziness, flushing, headache, trouble breathing, hives, itching, or skin rash, lightheadedness, fainting, fast, pounding, or uneven heartbeat, or trouble breathing after receiving this medicine.

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

Incidence unknown

  1. Blue lips, fingernails, or skin
  2. chills
  3. cloudy or bloody urine
  4. cough
  5. decreased cardiac output
  6. decreased frequency or amount of urine
  7. difficulty in speaking
  8. difficulty swallowing
  9. dilated neck veins
  10. double vision
  11. feeling of constant movement of self or surroundings
  12. fever
  13. high blood pressure
  14. inability to move the arms, legs, or facial muscles
  15. increased thirst
  16. irregular, fast, or slow, or shallow breathing
  17. lack or loss of strength
  18. loss of appetite
  19. lower back or side pain
  20. nausea
  21. no breathing
  22. no pulse or blood pressure
  23. noisy breathing
  24. pain in the joints
  25. pain or discomfort in the arms, jaw, back, or neck
  26. problems with muscle control or coordination
  27. seizures
  28. sensation of spinning
  29. severe or sudden headache
  30. shakiness and unsteady walk
  31. slow or slurred speech
  32. swollen, painful, or tender lymph glands in the neck, armpit, or groin
  33. temporary blindness
  34. throat tightness
  35. trembling
  36. trouble breathing
  37. unconsciousness
  38. vomiting
  39. weakness in the arm and/or leg on one side of the body, sudden and severe
  40. 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. 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 the throat
  9. fear
  10. feeling sad or empty
  11. fever, not related to infusion
  12. heartburn
  13. hoarseness
  14. indigestion
  15. irritability
  16. loss of interest or pleasure
  17. pain or tenderness around eyes and cheekbones
  18. paleness of skin
  19. runny nose
  20. sensation of change in temperature
  21. skeletal pain
  22. sneezing
  23. stuffy nose
  24. trouble concentrating
  25. trouble sleeping
  26. 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.