Agalsidase beta-rch [ag-al-SI-daze bee-ta R.C.H] 5.5 & 35 mg/mL, Powder for Concentrate for Solution for Infusion
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about FABRAZYME.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your treating physician has weighed the risks of you or your child taking FABRAZYME against the benefits they expect it will have.
If you have any concerns about taking this medicine, ask your treating physician or nurse.
Keep this leaflet.
You may need to read it again.
What FABRAZYME is used for
FABRAZYME is used as enzyme replacement therapy in Fabry's Disease, a disease in which the level of an enzyme called α-galactosidase is lower than normal.
How it works
Patients with Fabry's Disease do not produce enough of their own enzyme, α-galactosidase. The reduced α-galactosidase activity in patients results in the accumulation of substances called glycosphingolipids, predominantly globotriaosylceramide (GL-3) in a number of cell types and tissues.
FABRAZYME is an enzyme replacement therapy that is intended to restore a level of enzyme activity sufficient to remove the accumulated substances and to prevent further accumulation.
Before you are given FABRAZYME
When you or your child must not be given it
Do not take FABRAZYME if you have a known, severe, life-threatening allergic reaction to:
any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
skin rash, itching or hives.
If you are not sure whether you or your child should have FABRAZYME, talk to your treating physician or nurse.
Before you or your child are given it
Tell your treating physician if your child is under 8 years of age and has been prescribed FABRAZYME.
Safety in children below the age of 8 years has not been studied. If your child has been prescribed FABRAZYME, you may wish to discuss this with your child's treating physician.
Tell your treating physician if you or your child have reacted to previous treatments with FABRAZYME.
Tell your treating physician if you or your child have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes.
Tell your treating physician if you are pregnant or intend to become pregnant.
There is no information available regarding the use of FABRAZYME in pregnant women. Your treating physician will discuss the possible risks and benefits of having FABRAZYME during pregnancy.
Tell your treating physician if you are breast-feeding.
FABRAZYME is not recommended for use when breast-feeding as it is not known whether FABRAZYME passes into breast milk. If there is a need to consider using FABRAZYME while you are breast-feeding, your treating physician will discuss with you the benefits and risks of using it.
Taking other medicines
Tell your treating physician or nurse if you or your child are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
No studies have been carried out between FABRAZYME and other medicines. However, some medicines and FABRAZYME may interfere with each other.
Tell your treating physician or nurse if you or your child are using other medicines as these medicines may be affected by FABRAZYME, or may affect how well it works.
You or your child may need different amounts of these medicines or different medicines may need to be taken. Your treating physician or nurse will advise you and decide whether or not to give you or your child the medicine.
How FABRAZYME is given
The recommended dosage for FABRAZYME is 1 mg/kg of body weight once every two weeks. FABRAZYME will be given to you or your child directly into the vein (intravenously) by a trained health care professional in a hospital or a clinic.
The treating physician or nurse will decide on the dose that is most suitable. They will also tell you how long it will take to give the medicine. It may take several hours.
If you are given too much (overdose)
There have been no reported overdoses of FABRAZYME.
Things you or your child must do
Keep appointments with your treating physician or clinic.
It is important to have the FABRAZYME infusion at the appropriate times to make sure the medicine has the best chance of providing treatment for the condition.
After having FABRAZYME
Have any tests when your treating physician says to.
Your treating physician may wish to test you or your child's body's response to FABRAZYME to make sure that it is working.
Things to be careful of
Be careful driving or operating machinery until you know how FABRAZYME affects you.
The effect of FABRAZYME on your ability to drive a car or operate machinery has not been studied.
Make sure that you know how you react to FABRAZYME before you drive a car or operate machinery or do anything else that may be dangerous if you are dizzy, lightheaded, tired or drowsy.
Tell your treating physician or nurse as soon as possible if you or your child do not feel well after having FABRAZYME.
FABRAZYME may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not.
Ask your treating physician or nurse to answer any questions you may have.
Tell your treating physician or pharmacist if you notice any of the following and they worry you:
shortness of breath, wheezing or coughing, difficulty breathing
local reaction around the injection site such as redness, itchiness, tenderness, pain or discomfort, warmth, burning or stinging, swelling or the formation of hard lumps or scars
itchy rash, hives, itching or rash
flushing or redness of the skin
soreness, aching muscles, muscle tenderness, weakness (not caused by exercise), shaking or pins and needles
increase or decrease in your heart beat
swelling of the face, lips, mouth, tongue or throat
dizziness and lightheadedness
Other side effects not listed above may occur in some patients. Tell your treating physician if you notice anything making you feel unwell when you are taking, or soon after you have finished taking FABRAZYME.
FABRAZYME will be stored in the hospital or clinic pharmacy.
FABRAZYME will be used immediately after it has been prepared for infusion.
What it looks like
FABRAZYME is a white to off-white powder before it is prepared for infusion and a clear, colourless solution after it has been prepared for infusion.
mannitol, sodium phosphate - monobasic monohydrate, dibasic sodium phosphate heptahydrate.