Fabrazyme

Fabrazyme is used to treat Fabry disease, an inherited disease caused by the lack of the enzyme ‘alpha-galactosidase A’ in the body. This enzyme is necessary for your body to function properly.

Agalsidase beta is available only through your doctor’s prescription.

This product is available in the following forms:

• Powder for Solution

Before using Fabrazyme, you must know all about the risks and complications associated with it.

As with all medicines, the risks must be compared to how much a medication will help you. This is a decision that you and your doctor will make together. For this medication, there are many things that need to be considered:

• Allergies: Inform your doctor if you have ever had an allergic reaction to doxorubicin or to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.
• Pediatric: No appropriate studies have been performed on the relationship of age to the effects of this medication in children. Safety and efficacy have not been established.
• Geriatric: No appropriate studies have been performed on the relationship of age to the effects of this medication in the geriatric population. Safety and efficacy have not been established.
• Pregnancy: This medication is listed as Pregnancy Category B. This means that animal studies have revealed no evidence of harm to the unborn baby, however there are are no studies in pregnant women OR animal studies have showed an adverse affect to the unborn baby, but studies in pregnant women have not shown a risk to the unborn baby.
• Breastfeeding: There are no up-to-date studies in women for determining infant risk when using this medication while breastfeeding. Weigh the potential risks with the benefits before taking this medication while breastfeeding.
• Drug Interactions: Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases, your doctor may want to change your dose or take other precautions. When taking this medication, it is important that you inform your doctor if you are taking any other prescription or over the counter medications.
• Other Interactions: Certain medications should not be used while eating, or while eating certain foods in case of negative interactions. Using alcohol or tobacco with certain medications may also cause negative interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.
• Other Medical Problems: Pre-existing medical problems may affect the use of this medication. Be sure to tell your doctor if you have any other medical problems, especially: 
  • Heart problems - May be at a higher risk of severe complications from infusion reaction.

To use Fabrazyme correctly, you must follow all instructions given by your doctor.

Dosing

Different patients will be given a different dose of this medication based on the strength of the medication. The number of doses you take each day, the time between doses and the length of time you take this medication depends on the reason you are taking this medication. The following information only includes the average dose of this medication. If your dose is different, do not change it without first speaking to your doctor.

• For injection dosage form (for Fabry disease):

        -Adults - The dose is based on body weight and must be determined by your doctor. The normal dose is 1mg per kilogram of body weight, slowly injected into a vein. The dose may be repeated once every two weeks.
        -Children - Use and dose must be determined by your doctor.

Skipped Dose

Call your doctor or pharmacist for instructions.

In using Fabrazyme, you must be careful and take some precautions as advised by your doctor.

It is very important that your doctor monitors your progress while you receive this medication to make sure that the medication is working properly.

It is important to take the medication for treatment of infusion reaction prior to receiving your infusion.

It is important to receive this medication in a health care facility with medical support in case of severe reactions.

Fabrazyme may produce unwanted side effects along with the intended 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 you experience any of the following side-effects:

More common:

• Blurred vision
• Chest pain or discomfort
• Confusion
• Cough producing mucus
• Difficulty breathing
• Difficulty moving
• Dizziness
• Faintness or lightheadedness when getting up from a lying or sitting position suddenly
• Feeling unusually cold
• Headache
• Hives or welts
• Irregular heartbeat
• Itching
• Joint pain
• Muscle aching or cramping
• Muscle pains or stiffness
• Nervousness
• Pain
• Pounding in the ears (pulsatile tinnitus)
• Redness of skin
• Shortness of breath
• Skin rash
• Stomach pain
• Swelling of ankles, feet, and lower legs
• Swollen joints
• Tightness in the chest
• Unusual sweating
• Unusual fatigue or weakness
• Wheezing

Some side effects that may occur do not normally need medical attention. These may leave as your body becomes accustomed to treatment. Ask your doctor about ways to prevent or reduce some of these side effects. Talk to your doctor if any of the following side effects continue or are bothersome, or if you have questions:

More common:

• Acid or sour stomach
• Belching
• Body aches or pain
• Burning, crawling, itching, numbness, prickling, ""pins and needles"" , or tingling feelings
• Congestion
• Dryness or soreness of throat
• 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 (insomnia)
• Trouble swallowing
• Voice changes

Some patients may experience other side effects that are not listed. Check with your doctor if you notice any other side effects.

Ask your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.