It is given to treat the nonneurological
manifestations of the disease.
People with MPS I disease have either a low level or no level of an enzyme called
ŸLiduronidase,
which breaks down specific substances (glycosaminoglycans)
in the body. As a result, these substances do not get broken down and processed
by the body as they should. They accumulate in many tissues in the body, which
causes the symptoms of MPS I.
Aldurazyme is an artificial enzyme called laronidase. This can replace the
natural enzyme which is lacking in MPS I disease.

You should not be given Aldurazyme
If you are allergic (hypersensitive) to laronidase or any of the other ingredients
of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before using Aldurazyme. If you are treated with Aldurazyme,
you may develop infusionassociated
reactions. An infusionassociated
reaction
is any side effect occurring during the infusion or until the end of the infusion
day (see section 4 “Possible Side Effects”). Some of these reactions may be
severe. When you experience such a reaction, you should immediately contact
your doctor.
If these reactions occur, the Aldurazyme infusion should be stopped
immediately and appropriate treatment will be started by your doctor.
These reactions may be particularly severe if you have a preexisting
MPS
Irelated
upper airway obstruction.
You may be given additional medication such as antihistamines and paracetamol
to help prevent allergictype
reactions.
Other medicines and Aldurazyme
Inform your doctor if you are using medicines containing chloroquine or
procaine, due to a possible risk of decreasing the action of Aldurazyme.
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Pregnancy, breast-feeding and fertility
There is not enough experience of the use of Aldurazyme in pregnant women.
You should not be given Aldurazyme during pregnancy unless clearly necessary.
It is not known whether Aldurazyme appears in breast milk. It is recommended
to stop breastfeeding
during treatment with Aldurazyme.
No information is available on the effects of Aldurazyme on fertility.
If you are pregnant or breastfeeding,
think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before using
this medicine.

Driving and using machines
The effects on the ability to drive and to use machines have not been studied.
Aldurazyme contains sodium
This medicinal product contains 1.29 mmol sodium per vial. To be taken into
consideration by patients on a controlled sodium diet.

The concentrate for solution for infusion has to be diluted before administration
and is for intravenous use (see information for health care professionals).
Administration of Aldurazyme should be carried out in an appropriate clinical
setting where resuscitation equipment to manage medical emergencies would
be readily available.
Dosage
The recommended dosage regimen of Aldurazyme is 100 U/kg body weight
given once every week as an intravenous infusion. The initial infusion rate of
2 U/kg/h may be gradually increased every fifteen minutes, if tolerated, to a
maximum of 43 U/kg/h. The total volume of the administration should be
delivered in approximately 34
hours.
Always use this medicine exactly as your doctor has told you. Check with your
doctor if you are not sure.
If you miss an infusion of Aldurazyme
If you have missed an Aldurazyme infusion, please contact your doctor.
If you are given more Aldurazyme than needed
No case of overdose of Aldurazyme has been reported.
If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody
gets them.
Side effects were mainly seen while patients were being given the medicine or
shortly after (infusionassociated
reactions). If you experience any reaction like
this, you should contact your doctor immediately. The number of these reactions
decreased the longer that patients were on Aldurazyme. The majority of these
reactions were mild or moderate in intensity. However, severe systemic allergic
reaction (anaphylactic reaction) has been observed in patients during or up to
3 hours after Aldurazyme infusions. Some of the symptoms of such a severe
allergic reaction were lifethreatening
and included extreme difficulty breathing,
swelling of the throat, low blood pressure, and low oxygen level in the body.
A few patients who had a prior history of severe MPS I related upper airway and
pulmonary involvement, experienced severe reactions including bronchospasm
(airway constriction), respiratory arrest, and swelling of the face. The frequency
of bronchospasm and respiratory arrest is unknown. The frequency of severe
allergic reaction (anaphylactic reaction) and swelling of the face is considered
common and may affect up to 1 in 10 people.
Very common symptoms (may affect more than 1 in 10 people) which were not
serious include headache, nausea, abdominal pain, rash, joint disease, joint
pain, back pain, pain in arms or legs, flushing, fever, chills, increased heart rate,
increased blood pressure, and reaction at the infusion site.

Other side effects include the following:
Common (may affect up to 1 in 10 people)
• increased body temperature
• tingling
• dizziness
• cough
• difficulty in breathing
• vomiting
• diarrhoea
• swelling of the neck
• hives
• itching
• hair loss
• cold sweat, heavy sweating
• muscle pain
• paleness
• cold hands or feet
• feeling hot, feeling cold
• fatigue
• influenza like illness
• restlessness
Not known (frequency cannot be estimated from the available data)
• bluish color of the skin (due to lower levels of oxygen in the blood)
• fast breathing
• redness of the skin
• leakage of the drug into the surrounding tissue at the site of injection, which
may cause swelling or redness
• swelling of arms and/or legs
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects
directly via the contact details listed below. By reporting side effects you can
help provide more information on the safety of this medicine
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
IMB Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6767836
Website: www.imb.ie
email:
imbpharmacovigilance@imb.ie

Keep this medicine out of the sight and reach of children.
You should not be given this medicine after the expiry date which is stated on the
label after the letters EXP. The expiry date refers to the last day of that month.
Unopened vials:
Store in a refrigerator (2°C – 8°C).
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away me