Generic drug: agalsidase beta
Brand name: Fabrazyme
What is Fabrazyme (agalsidase beta), and how does it work?
Fabrazyme (agalsidase beta) for intravenous infusion is a man-made form of the naturally-occurring enzyme a-galactosidase A that is used in the treatment of Fabry disease.
What are the side effects of Fabrazyme?
Common side effects of Fabrazyme include signs of allergic reaction such as:
- difficulty breathing
- closing of the throat
- chest tightness
- high or low blood pressure
- fast heartbeats
- muscle pain
- stomach pain
- nausea or vomiting
- numbness or tingling, and
What is the dosage for Fabrazyme?
- The recommended dosage of Fabrazyme is 1 mg/kg body weight infused every two weeks as an intravenous infusion.
- Infusion rate:
- The initial intravenous infusion rate is 0.25 mg/min (15 mg/hour). Slow the infusion rate in the event of infusion-associated reactions.
- For patients > 30 kg, after patient tolerance to the infusion is well established, increase the infusion rate in increments of 0.05 to 0.08 mg/min (increments of 3 to 5 mg/hour) with each subsequent infusion. The minimum infusion duration is 1.5 hours (based on individual patient tolerability).
- For patients weighing < 30 kg, the maximum infusion rate is 0.25 mg/minute (15 mg/hour).
- Because of the potential for severe infusion-associated reactions, appropriate medical support measures should be readily available when Fabrazyme is administered.
- Administer antipyretics prior to infusion of Fabrazyme.
- Rechallenge: Patients who have had a positive skin test to Fabrazyme or who have tested positive for anti-Fabrazyme IgE may be successfully rechallenged with Fabrazyme. The initial rechallenge administration should be a low dose at a lower infusion rate, e.g., ½ the therapeutic dose (0.5 mg/kg) at 1/25 of the initial standard recommended rate (0.01 mg/min). Once a patient tolerates the infusion, the dose may be increased to reach the approved dose of 1 mg/kg and the infusion rate may be increased by slowly titrating upwards (doubled every 30 minutes up to a maximum rate of 0.25 mg/minute), as tolerated.
Is Fabrazyme safe to use while pregnant or breastfeeding?
- Pregnant women and women of reproductive potential should be encouraged to enroll in the Fabry patient registry.
- The registry will monitor the effect of Fabrazyme on pregnant women and their offspring.
- For more information, visit www.registrynxt.com or call 1-800-745-4447, extension 15500.
- There are no data on the presence of agalsidase beta in either human or animal milk, the effects of the drug on the breastfed infant, or on milk production.
- The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Fabrazyme and any potential adverse effects on the breastfed child from Fabrazyme or from the underlying maternal condition.
- Lactating women with Fabry disease treated with Fabrazyme should be encouraged to enroll in the Fabry registry.
Fabrazyme (agalsidase beta) for intravenous infusion is a man-made form of the naturally-occurring enzyme a-galactosidase A that is used in the treatment of Fabry disease. Common side effects of Fabrazyme include signs of allergic reaction such as difficulty breathing, closing of the throat, hives, rash, itching, fever, shaking, chest tightness, high or low blood pressure, fast heartbeats muscle pain, stomach pain, nausea or vomiting, dizziness, numbness or tingling, and headache.
Multimedia: Slideshows, Images & Quizzes
Childhood Diseases: Measles, Mumps, & More
Is your child at risk for these childhood diseases? Know when to call the doctor for conditions such as measles, mumps, ringworm,...
Common Childhood Skin Disorders
What are the most common skin rashes in children? Learn about childhood eczema, ring worm, chicken pox and more. Get the facts on...
10 Common Symptoms in Infants and Young Toddlers
Watch this slideshow to see common symptoms and home treatment for infant and childhood illnesses including fever, nausea,...
Genetics: 11 Surprising Things Your Genes Say About You
Explore what role DNA plays in your health, love life, and more in this WebMD slideshow.
Family Health History: Genetics, DNA Testing and Your Health
WebMD explains why your doctor asks about your relatives' health conditions and how you can get the information if you don’t know.
Related Disease Conditions
The definition of a genetic disease is a disorder or condition caused by abnormalities in a person's genome. Some types of genetic inheritance include single inheritance, including cystic fibrosis, sickle cell anemia, Marfan syndrome, and hemochromatosis. Other types of genetic diseases include multifactorial inheritance. Still other types of genetic diseases include chromosome abnormalities (for example, Turner syndrome, and Klinefelter syndrome), and mitochondrial inheritance (for example, epilepsy and dementia).
Fabry disease (Fabry's disease, alpha-galactosidase-A) is a genetic disorder with symptoms such as burning sensations in the hands, small-raised reddish-purplish blemishes on the skin, fever, decreases sweating, and gastrointestinal (GI) difficulties. Fabry disease patients are at increased risk of heart attack, heart disease, kidney failure, and stroke. Symptoms of Fabry disease can be treated with medication.
Your health care provider may refer you to a genetic professional. Universities and medical centers also often have affiliated genetic professionals, or can provide referrals to a genetic professional or genetics clinic. Genetic counseling provides patients and family members the tools to make the right choice in regard to test for a disease or condition.
Who Should Get Genetic Counselling?
Genetic counseling is the process that helps you in determining hereditary or genetic (running in your family) problems that might affect you or your family. It is done by a trained professional.
Genetic Testing: Families With Breast Cancer
Breast cancer can be a killer and the decision to get tested to see if a patient is prone to the disease should be discussed with a doctor -- particularly if the woman has a history of breast cancer in her family. Genetic testing can only tell so much about breast cancer risk, however.
Treatment & Diagnosis
Medications & Supplements
Prevention & Wellness
Latest Healthy Kids News
Daily Health News
Health Solutions From Our Sponsors
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.