Health Guide
Drug Guide

Agalsidase beta (Intravenous route)

Pronunciation:

aye-GAL-si-days BAY-ta

Brand Names:

Dosage Forms:

Classifications:

Therapeutic

Endocrine-Metabolic Agent

Pharmacologic

Enzyme

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children

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.

Older adults

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

Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast-feeding

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.

Other medicines

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:

Proper Use of This Medicine:

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.

Missed dose

Call your doctor or pharmacist for instructions.

Precautions While Using This Medicine:

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 This Medicine:

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
Blurred vision
chest pain or discomfort
confusion
cough producing mucus
difficulty breathing
difficulty in moving
dizziness;
fatigue
faintness or lightheadedness when getting up from a lying or sitting position suddenly
feeling unusually cold shivering
headache
hives or welts
irregular heartbeat
itching
joint pain
muscle aching or cramping
muscle pains or stiffness
nervousness
pain
pounding in the ears
redness of skin
shortness of breath
skin rash
stomach pain
sweating
swelling of ankles, feet, and lower legs
swollen joints
tightness in chest
unusual tiredness or weakness
wheezing
Incidence unknown
Cloudy or bloody urine
decreased cardiac output
difficulty in speaking
double vision
feeling of constant movement of self or surroundings
high blood pressure
inability to move arms, legs, or facial muscles
inability to speak
no blood pressure or pulse
partial loss of hearing
pounding or rapid pulse
problems with muscle control or coordination
sensation of spinning
shakiness and unsteady walk
slow speech
stopping of heart
swelling of face
swelling of the lip or ear
throat tightness
trembling
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
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 throat
fear
feeling sad or empty
fever, not related to infusion
heartburn
hoarseness
indigestion
irritability
lack of appetite
loss of interest or pleasure
nausea
pain or tenderness around eyes and cheekbones
paleness of skin
runny nose
sensation of change in temperature
skeletal pain
sneezing
stuffy nose; swelling of testes
tender, swollen glands in neck
trouble concentrating
trouble sleeping
trouble in swallowing
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.


Last Updated: 10/12/2016

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