Fabrazyme Side Effects
Generic Name: agalsidase beta
Note: This document contains side effect information about agalsidase beta. Some of the dosage forms listed on this page may not apply to the brand name Fabrazyme.
Some side effects of Fabrazyme may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to agalsidase beta: intravenous powder for solution
Along with its needed effects, agalsidase beta (the active ingredient contained in Fabrazyme) 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 while taking agalsidase beta:More common
- Blurred vision
- chest pain or discomfort
- cough producing mucus
- difficulty breathing
- difficulty in moving
- faintness or lightheadedness when getting up from a lying or sitting position suddenly
- feeling unusually cold shivering
- hives or welts
- irregular heartbeat
- joint pain
- muscle aching or cramping
- muscle pains or stiffness
- pounding in the ears
- redness of skin
- shortness of breath
- skin rash
- stomach pain
- swelling of ankles, feet, and lower legs
- swollen joints
- tightness in chest
- unusual tiredness or weakness
- 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
Some side effects of agalsidase beta 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
- 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
- dryness or soreness of throat
- feeling sad or empty
- fever, not related to infusion
- lack of appetite
- loss of interest or pleasure
- pain or tenderness around eyes and cheekbones
- paleness of skin
- runny nose
- sensation of change in temperature
- skeletal pain
- stuffy nose; swelling of testes
- tender, swollen glands in neck
- trouble concentrating
- trouble sleeping
- trouble in swallowing
- voice changes
For Healthcare Professionals
Applies to agalsidase beta: intravenous powder for injection
In general, infusion-related side effects have been reported the most frequently. These have included tachycardia, hypertension, urticaria, chest pain, fever, and rigors. Temperature changed sensation and pallor have also been reported.
Cardiovascular side effects have included hypertension (greater than 10%), reports of cardiomegaly, hypotension, and edema.
Nervous system side effects including pain related to Fabry disease and headache have been reported in greater than 10% of patients. Cerebrovascular events (i.e., symptomatic stroke or transient ischemic attack) were reported in 9% of patients. Dizziness and paraesthesia have also been reported.
Gastrointestinal side effects have included reports of dyspepsia and nausea.
Musculoskeletal side effects have included reports of arthrosis and skeletal pain.
Psychiatric side effects have included reports of anxiety and depression.
Respiratory side effects have included reports of bronchitis, bronchospasm, laryngitis, pharyngitis, rhinitis, and sinusitis.
Genitourinary side effects reported by men involved in the placebo controlled study have included testicular pain.
Immunologic side effects have included reports of the development of antibodies to agalsidase beta (the active ingredient contained in Fabrazyme) Most patients involved in clinical studies developed antibodies within the first 3 months of exposure.
The reported rates of IgG seroconversion during the clinical studies were 88% and 89%. There are reports of decrease in titers after 12 months of treatment and one case that became seronegative. Seroconversion did not affect the efficacy end points. The clinical significance of the antibodies to agalsidase beta is not yet known.
Other side effects including chills have been reported in greater than 10% of patients.
More about Fabrazyme (agalsidase beta)
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