Fabrazyme

This enzyme is necessary for your body .

Agalsidase beta is available only with your doctor`s prescription.

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

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.

Geriatric

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

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 problemsa€”May be at a higher risk of severe complications from infusion reaction .

Proper Use

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.

• For Fabry disease:
  
  
  
  • For injection dosage form:
    
    
    
    • Adultsa€”The dose is based on body weight and must be determined by your doctor . The usual dose is 1 mg per kilogram (kg) of body weight, injected slowly into a vein . The dose may be repeated once every 2 weeks.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Missed Dose

Call your doctor or pharmacist for instructions.

Precautions

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

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.