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Aldurazyme 100 U/ml concentrate for solution for infusion

Last Updated on eMC 13-Sep-2017 View changes  | Genzyme Therapeutics Contact details

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

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Text only version for the visually impaired
Below is a text only representation of the Patient Information leaflet. The original may contain images or tables and can be viewed in PDF format using the link to the left. This PIL may be available from the RNIB in large print, Braille or audio CD. For further information please call the RNIB Medicine Leaflet line on 0800 198 5000. The product code(s) for this leaflet is/are: EU/1/03/253/003, EU/1/03/253/002, EU/1/03/253/001.



Aldurazyme 100 U/ml concentrate for solution for infusion

Package leaflet: Information for the user

Aldurazyme 100 U/ml concentrate for solution for infusion

Laronidase

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or your pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Aldurazyme is and what it is used for
2. What you need to know before you are given Aldurazyme
3. How Aldurazyme is given
4. Possible side effects
5. How to store Aldurazyme
6. Contents of the pack and other information

1. What Aldurazyme is and what is it used for

Aldurazyme is used to treat patients with MPS I disease (Mucopolysaccharidosis I). It is given to treat the non-neurological manifestations of the disease.

People with MPS I disease have either a low level or no level of an enzyme called α-L-iduronidase, 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.

2. What you need to know before you are given Aldurazyme

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 infusion-associated reactions. An infusion-associated 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 pre-existing MPS I-related upper airway obstruction.

You may be given additional medication such as antihistamines and paracetamol to help prevent allergic-type 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 breast-feeding during treatment with Aldurazyme.

No information is available on the effects of Aldurazyme on fertility.

If you are pregnant or breast-feeding, 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.

3. How Aldurazyme is given

Instruction for use - dilution and administration

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 3-4 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.

4. Possible side effects

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 (infusion-associated 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 life-threatening 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 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

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website:www.hpra.ie
e-mail:medsafety@hpra.ie

Malta

ADR Reporting
Website:www.medicinesauthority.gov.mt/adrportal

5. How to store Aldurazyme

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 medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Aldurazyme contains

  • The active substance is laronidase. One ml of the solution in the vial contains 100 U of laronidase. Each vial of 5 ml contains 500 U of laronidase.
  • The other ingredients are sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, polysorbate 80, water for injections.

What Aldurazyme looks like and contents of the pack

Aldurazyme is supplied as a concentrate for solution for infusion. It is a solution that is clear to slightly opalescent, and colourless to pale yellow.

Pack size: 1, 10 and 25 vials per carton. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Genzyme Europe B.V.
Gooimeer 10
NL-1411 DD
Naarden
The Netherlands

Manufacturer

Genzyme Ltd.
37 Hollands Road
Haverhill
Suffolk
CB9 8PU
United Kingdom

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom
Sanofi
Tel: +44 (0)845 372 7101

This leaflet was last revised in 09/2017

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

Company contact details

Genzyme Therapeutics

Company image
Address

4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford, Oxfordshire, OX4 2SU

Fax

+44 (0)1865 774 172

Medical Information e-mail
Medical Information Fax

+44 (0)1865 774 172

Telephone

+44 (0)1865 405 200

Medical Information Direct Line

+44 (0)1865 405 283

Customer Care direct line

+44 (0)1865 405 200

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

laronidase

Legal categories

POM - Prescription Only Medicine

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