Description
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 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 at least 1½ hours.
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 chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, skin rash, 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
- Blurred vision
- chest pain, discomfort, or tightness
- confusion
- cough producing mucus
- difficulty breathing
- difficulty in moving
- dizziness
- faintness or lightheadedness when getting up suddenly from a lying or sitting position
- feeling unusually cold shivering
- headache
- hives or welts, itching, skin rash
- irregular heartbeat
- joint pain
- muscle ache, cramps, pains, or stiffness
- nervousness
- pounding in the ears
- redness of the skin
- stomach pain
- sweating
- swelling of the ankles, feet, and lower legs
- swollen joints
- unusual tiredness or weakness
Incidence unknown
- Blue lips, fingernails, or skin
- chills
- cloudy or bloody urine
- cough
- decreased cardiac output
- decreased frequency or amount of urine
- difficulty in speaking
- difficulty swallowing
- dilated neck veins
- double vision
- fast heartbeat
- feeling of constant movement of self or surroundings
- fever
- high blood pressure
- inability to move the arms, legs, or facial muscles
- increased thirst
- irregular, fast, or slow, or shallow breathing
- lack or loss of strength
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- lower back or side pain
- nausea
- no breathing
- no pulse or blood pressure
- noisy breathing
- pain in the joints
- pain or discomfort in the arms, jaw, back, or neck
- problems with muscle control or coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- seizures
- sensation of spinning
- severe or sudden headache
- shakiness and unsteady walk
- slow or slurred speech
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- temporary blindness
- throat tightness
- trembling
- trouble breathing
- unconsciousness
- vomiting
- weakness in the arm or leg on one side of the body, sudden and severe
- 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
- Acid or sour stomach
- belching
- body aches or pain
- body produces substance that can bind to drug making it less effective or cause side effects
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- congestion
- discouragement
- dryness or soreness of the throat
- fear
- feeling sad or empty
- fever, not related to infusion
- heartburn
- hoarseness
- indigestion
- irritability
- loss of interest or pleasure
- pain or tenderness around eyes and cheekbones
- paleness of skin
- runny nose
- sensation of change in temperature
- skeletal pain
- sneezing
- stuffy nose
- trouble concentrating
- trouble sleeping
- 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.
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