Fabrazyme 5 mg powder for concentrate for solution for infusion
Agalsidase beta
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Fabrazyme is and what it is used for
- 2. Before you use Fabrazyme
- 3. How to use Fabrazyme
- 4. Possible side effects
- 5. How to store Fabrazyme
- 6. Further information
What Fabrazyme Is And What It Is Used For
Fabrazyme is used as enzyme replacement therapy in Fabry disease, where the level of α-galactosidase enzyme activity is absent or lower than normal. If you suffer from Fabry disease a fat substance, called globotriaosylceramide (GL-3), is not removed from the cells of your body and starts to accumulate in the walls of the blood vessels of your organs.
Fabrazyme is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease.
Before You Use Fabrazyme
Do not use Fabrazyme
If you have experienced an allergic anaphylactic reaction to agalsidase beta or if you are allergic (hypersensitive) to any of the other ingredients of Fabrazyme.
Take special care with Fabrazyme
If you are treated with Fabrazyme, you may develop infusion associated reactions. An infusion-associated reaction is any side effect occurring during the infusion or until the end of the infusion day (See 4 “Possible Side Effects”). If you experience a reaction like this, you should tell your doctor immediately. You may need to be given additional medicines to prevent such reactions from occurring.
Different groups of patients using Fabrazyme
The information in this leaflet applies to all patient groups including children, adolescents, adults and the elderly.
Using other medicines
There are no known interactions with other medicinal products. Fabrazyme should not be administered with chloroquine, amiodarone, benoquin or gentamicin due to a theoretical risk of decreased agalsidase beta activity. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Using Fabrazyme with food and drink
Interactions with food and drink are unlikely.
Pregnancy and breast-feeding
Use of Fabrazyme during pregnancy is not recommended. There is no experience with the use of Fabrazyme in pregnant women. Fabrazyme may get into breast milk. Use of Fabrazyme during breast-feeding is not recommended. Ask your doctor or pharmacist for advice before taking this medicine.
How To Use Fabrazyme
Fabrazyme is given through a drip into a vein (by intravenous infusion). It is supplied as a powder which will be mixed with sterile water before it is given (see information for Health Care Professionals)
Fabrazyme is only used under the supervision of a doctor who is knowledgeable in the treatment of Fabry disease.
The recommended dose of Fabrazyme for adults and children 8 – 16 years is 1 mg/kg body weight, once every 2 weeks. No changes in dose are necessary for patients with kidney disease.
If you use more Fabrazyme than you should
There are no cases of overdose of Fabrazyme reported. Doses up to 3 mg/kg body weight have shown to be safe.
If you forget to use Fabrazyme
If you have missed an infusion of Fabrazyme, please contact your doctor.
Possible Side Effects
Like all medicines, Fabrazyme can cause side effects, although not everybody gets them.
In clinical studies side effects were mainly seen while patients were being given the medicine or shortly after. If you experience any serious side effect or side effects not listed, please tell your doctor immediately.
In clinical trials the following side effects were reported:
Very common (occurring in more than 1 in 10 patients):
- chills
- fever
- headache
- abnormal touch feeling (pins and needles)
- nausea
- vomiting
- feeling cold
Common (occurring in 1 in 100 to 1 in 10 patients):
- chest pain
- difficulty in breathing
- pallor
- itching
- abnormal tear secretion
- feeling weak
- tinnitus
- nasal congestion
- diarrhoea
- redness
- muscle pain
- increased blood pressure
- sudden swelling of the face or throat
- oedema in extremities
- vertigo
- stomach discomfort
- muscle spasms
- sleepiness
- increased heart beat
- abdominal pain
- back pain
- rash
- low heart rate
- lethargy
- syncope
- cough
- abdominal discomfort
- swelling face
- joint pain
- decreased blood pressure
- chest discomfort
- face oedema
- exacerbated difficulty in breathing
- muscle tightness
- fatigue
- flushing
- pain
- throat tightness
- dizziness
- palpitations
- decreased sensitivity to pain
- burning sensation
- wheezing
- urticaria
- pain at the extremities
- nasopharyngitis
- hot flush
- feeling hot
- hyperthermia
- decreased mouth sensitivity
- musculoskeletal stiffness
Uncommon (occurring in 1 in 1000 to 1 in 100 patients):
- tremor
- red eyes
- ear pain
- throat pain
- fast breathing
- itchy rash
- feeling hot and cold
- difficulty swallowing
- infusion site pain
- infusion site reaction
- itching eyes
- ear swelling
- bronchospasm
- runny nose
- heart burn
- skin discomfort
- musculoskeletal pain
- rhinitis
- influenza-like illness
- malaise
- low heart rate due to conduction disturbances
- increased sensitivity to pain
- upper respiratory tract congestion
- red rash
- (mottled purplish) skin discoloration
- coldness of the extremities
- injection site blood clotting
- skin discoloration
- oedema
Unknown frequency
- Serious allergic reactions
- serious inflammation of the vessels
- lower blood oxygen levels
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Fabrazyme
Keep out of the reach and sight of children.
Unopened vials
Store in a refrigerator (2 °C – 8 °C).
Do not use Fabrazyme after the expiry date which is stated on the labelling after the letters ‘EXP’.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
What Fabrazyme contains
- The active substance is agalsidase beta, one vial contains 5 mg.
- Other ingredients are:
- Mannitol
- Sodium phosphate monobasic, monohydrate
- Sodium phosphate dibasic, heptahydrate.
What Fabrazyme looks like and contents of the pack
Fabrazyme is supplied as a white to off-white powder. After reconstitution it is a clear, colourless liquid, free from foreign matter. The reconstituted solution must be further diluted. Package sizes: 1, 5 and 10 vials per carton. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder
Manufacturer
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom/Ireland
This leaflet was last approved in 01/2010
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu. There are also links to other websites about rare diseases and treatments.
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