Myozyme 50 mg powder for concentrate for solution for infusion
Alglucosidase alfa
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 Myozyme is and what it is used for
- 2. Before you use Myozyme
- 3. How to use Myozyme
- 4. Possible side effects
- 5. How to store Myozyme
- 6. Further information
What Myozyme Is And What It Is Used For
Myozyme is used to treat patients who have a confirmed diagnosis of Pompe disease.
People with Pompe disease have low levels of an enzyme called α-glucosidase. This enzyme helps the body control levels of glycogen (a type of carbohydrate). Glycogen provides the body with energy, but in Pompe disease the levels can get too high.
Myozyme is an artificial enzyme called alglucosidase alfa – this can replace the natural enzyme which is lacking in Pompe disease.
In patients with late-onset Pompe disease a positive effect was observed over an 18 month period on lung function and walking ability. The evidence on the effect of Myozyme in severely affected patients with late onset Pompe disease is limited.
Before You Use Myozyme
Do not use Myozyme
If you are allergic (hypersensitive) to alglucosidase alfa or any of the other ingredients of Myozyme.
Take special care with Myozyme
If you are treated with Myozyme, you may experience a reaction while you are being given the medicine or during the next 2 hours. This is known as an infusion-associated reaction and can sometimes be very severe. If you experience a reaction like this, you should tell your doctor immediately. You may need to be given additional medicines to prevent an allergic reaction (e.g. antihistamines and/or corticosteroids) or antipyretics.
Different groups of patients using Myozyme
The information in this leaflet applies to all patient groups including children, adolescents, adults and the elderly.
Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
There is no experience of the use of Myozyme in pregnant women. Myozyme should not be used during pregnancy unless clearly necessary. It is recommended to stop breast-feeding when Myozyme is used. Ask your doctor or pharmacist for advice before taking any medicine.
How To Use Myozyme
Instructions for proper use
Myozyme 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.
Myozyme is only used under the supervision of a doctor who is knowledgeable in the treatment of Pompe disease.
The recommended dosage of Myozyme is 20 mg/kg body weight given once every 2 weeks.
If you use more Myozyme than you should
There are no cases of overdose reported.
If you forget to use Myozyme
If you have missed an infusion, please contact your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, Myozyme can cause side effects, although not everybody gets them.
Side effects were mainly seen while patients were being given the medicine or shortly after (“infusion related effects”). Some of these infusion related side effects became serious. Should you experience any reaction like this, please tell your doctor immediately. You may need to be given additional medicines to prevent an allergic reaction (e.g. antihistamines and/or corticosteroids) or antipyretics.
- Hives
- Rash
- Paleness
- Redness of the skin
- (Facial) flushing
- Increased or high blood pressure
- Bluish discolouration of the skin
- Fever or increased body temperature
- Chills
- Cough
- Increased breathing rate
- Increased or decreased heart rate
- Vomiting
- Agitation
- Tremor
- Swelling around the eyes
- Abnormal breathing sounds
- Difficulty in breathing (including shortness of breath)
- Headache
- Cold extremities (e.g. hands, feet)
- Tingling
- Pain or local reaction at the site of the drip
- Dizziness
- Irritability
- Itchy skin
- Retching
- Low blood pressure
- Bronchospasm
- Low level of oxygen in the blood
- Swelling of the face, swelling of the throat or severe combined swelling of the face, throat and tongue due to a severe allergic reaction
- Swelling of the arms and legs
- Feeling hot
- Increased sweating
- Eyes tearing
- Mottled skin
- Nausea
- Restlessness
- Wheezing
- Heart stopping
- Chest discomfort
- Chest pain (not in the heart)
- Throat tightness
- Diarrhoea
- Fatigue
- Muscle pain
- Muscle spasms
Life threatening reactions, including very severe generalised allergic reactions and anaphylactic shock, have been reported in some patients.
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 Myozyme
Keep out of the reach and sight of children
Store in a refrigerator (2°C – 8°C).
Do not use after the expiry date stated on the labelling after the letters ‘EXP’.
It is recommended that Myozyme is used immediately after it has been mixed with sterile water. However it can be kept for up to 24 hours if it is kept cool (2°C – 8°C) and in the dark.
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 Myozyme contains
- The active substance is alglucosidase alfa 50 mg. One vial contains 50 mg of alglucosidase alfa. After reconstitution, the solution contains 5 mg of alglucosidase alfa/ml and after dilution, the concentration varies from 0.5 mg to 4 mg/ml.
- The other ingredients are
- mannitol,
- sodium phosphate monobasic monohydrate
- sodium phosphate dibasic heptahydrate
- polysorbate 80
What Myozyme looks like and contents of the pack
Myozyme, 50 mg, is presented as a powder for concentrate for solution for infusion (in a vial- pack: sizes of 1, 10 or 25). Not all pack sizes may be marketed.
Myozyme is supplied as a white to off-white powder. After reconstitution it is a clear, colourless to pale yellow solution, which may contain particles. The reconstituted solution must be further diluted.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom/Ireland
This leaflet was last approved in 10/2009
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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