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Naglazyme (galsulfase) – Package leaflet - A16AB

Updated on site: 08-Oct-2017

Medication nameNaglazyme
ATC CodeA16AB
Substancegalsulfase
ManufacturerBioMarin Europe Ltd.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Naglazyme 1 mg/ml concentrate for solution for infusion

Galsulfase

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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.

-If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

What is in this leaflet:

1.What this medicine is and what it is used for

2.What you need to know before you are given this medicine

3.How this medicine is given

4.Possible side effects

5.How to store this medicine

6.Contents of the pack and other information

1.What this medicine is and what it is used for

Naglazyme is used to treat patients with MPS VI disease (Mucopolysaccharidosis VI).

People with MPS VI disease have either a low level, or no level, of an enzyme called N-acetylgalactosamine 4-sulfatase, 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 VI.

How this medicine works

This medicine contains a recombinant enzyme called galsulfase. This can replace the natural enzyme which is lacking in MPS VI patients. Treatment has been shown to improve walking and stair- climbing ability, and to reduce the levels of glycosaminoglycans in the body. This medicine may improve the symptoms of MPS VI.

2. What you need to know before you are given this medicine

You must not receive this medicine

-If you have experienced severe or life-threatening allergic (hypersensitive) reactions to galsulfase or any of the other ingredients of Naglazyme and re-administration of the medicine was not successful.

Warnings and precautions

-If you are treated with Naglazyme, 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”). When you experience such a reaction, you should immediately contact your doctor.

-If you have an allergic reaction your doctor may slow down, or stop, your infusion. Your doctor may also give you additional medicines to manage any allergic reactions.

-If you have a fever, or if you are having difficulty breathing before this medicine is given, talk with your doctor about delaying your Naglazyme infusion.

-This medicine has not been tested in patients with kidney or liver problems. Talk to your doctor if you have kidney or liver insufficiency.

-Please talk to your doctor if you experience muscle pain, numbness in your arms or legs, or any bowel or bladder problems as these may be caused by pressure on your spinal cord.

Other medicines and Naglazyme

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

Naglazyme should not be given during pregnancy unless clearly necessary. Ask your doctor or pharmacist for advice before taking any medicine. It is not known whether galsulfase is excreted in milk, therefore breast-feeding should be stopped during Naglazyme treatment. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

This medicine contains Sodium

Each 5 ml vial contains 0.8 mmol (18.4 mg) of sodium. To be taken into consideration by patients on a controlled sodium diet.

3.How this medicine is given

Your doctor or nurse will administer Naglazyme to you.

The dose you receive is based on your body weight. The recommended dose is 1 mg/kg body weight administered once every week through a drip into a vein (by intravenous infusion). Each infusion will take approximately 4 hours. For the first hour the infusion rate will be slow (approximately 2.5% of the total solution), with the remaining volume (approximately 97.5%) being taken over the next 3 hours.

If you are given more Naglazyme than you should

Naglazyme is administered under the supervision of a nurse or doctor, he or she will check that the correct dose has been given and act accordingly if necessary.

If you forget to take this medicine

If you have missed a Naglazyme infusion, please contact your doctor. If you have any further questions on the use of this medicine, ask your doctor.

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”). The most serious side effects were swollen face and fever (very common); longer than normal gaps between breaths, difficulty breathing, asthma and hives (common); and swelling of the tongue and throat, and serious allergic reaction to this medicine (unknown frequency).

If 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 to reduce fever (antipyretics).

The most common symptoms of infusion associated reactions include fever, chills, rash, hives and shortness of breath.

Very common side effects (these may affect more than 1 in 10 people):

Sore throat

Nasal congestion

Gastroenteritis

Bulging belly button

Poor reflexes

Vomiting

Headache

Nausea

Inflammation of the eye

Itching

Cloudy eyes

Pain (including ear, abdominal, joint, chest

Poor hearing

pain)

High blood pressure

Malaise

Common side effects (these may affect up to 1 in 10 people):

Tremor

 

Wheezing

 

Low blood pressure

 

Skin redness

 

Cough

 

 

Other side effects with an unknown frequency:

Shock

Bluish skin

Tingling

Skin paleness

 

Decreased heart rate

 

Low blood-oxygen

 

Increased heart rate

 

Rapid breathing

If you get any of these symptoms, or other symptoms not listed in this leaflet, tell your doctor immediately. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store this medicine

Keep out of the sight and reach of children.

Do not take use this medicine after the expiry date which is stated on the vial after EXP. The expiry date refers to the last day of that month.

Unopened vials:

Store in a refrigerator (2 C - 8 C).

Do not freeze.

Diluted solutions:

Chemical and physical in-use stability has been demonstrated for up to 4 days at room temperature (23 C - 27 C).

From a microbiological safety point of view, the product is to be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and must normally not be longer than 24 hours at 2 C - 8 C followed by up to 24 hours at room temperature

(23 C - 27 C) during administration.

Do not take Naglazyme if it contains visible particles.

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.

6. Contents of the pack and other information

What Naglazyme contains

-The active substance is galsulfase. One ml of Naglazyme contains 1 mg galsulfase. One vial of 5 ml contains 5 mg galsulfase. Galsulfase is recombinant human N-acetylgalactosamine 4-sulfatase produced by genetically engineered Chinese Hamster Ovary (CHO) cells.

-The other ingredients are: sodium chloride, sodium phosphate monobasic, monohydrate, sodium phosphate dibasic, heptahydrate, polysorbate 80, water for injections.

What Naglazyme looks like and contents of the pack

Naglazyme is supplied as a concentrate for solution for infusion. The clear to slightly opalescent and colourless to pale yellow concentrate must be free of visible particles. The solution must be diluted further before it can be infused.

Pack sizes: 1 and 6 vials. Not all package sizes may be marketed.

Marketing Authorization Holder

Manufacturer

BioMarin Europe Limited

Catalent UK Packaging Ltd.

10 Bloomsbury Way

Wingates Industrial Park,

London, WC1A 2SL

Westhoughton, Bolton,

United Kingdom

Lancs, BL5 3XX

 

United Kingdom

 

BioMarin International Limited

 

Shanbally, Ringaskiddy

 

County Cork

 

Ireland

 

This medicine has been authorised under “exceptional circumstances”.

This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.

The European Medicines Agency will review any new information on the medicine every year and this leaflet will be updated as necessary.

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.

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The following information is intended for medical or healthcare professionals only:

 

Naglazyme should not be mixed with other medicinal products in the same infusion, except for those mentioned below.

Each vial of Naglazyme is intended for single use only. The concentrate for solution for infusion has to be diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion using aseptic technique. It is

recommended that the diluted Naglazyme solution be administered to patients using an infusion set equipped with a 0.2 µm in-line filter.

Any unused product or waste material is to be disposed of in accordance with local requirements.

Preparation of the Naglazyme Infusion (Use Aseptic Technique)

The number of vials to be diluted based on the individual patient's weight must be determined and removed from the refrigerator approximately 20 minutes in advance in order to allow them to reach room temperature.

Before dilution, each vial is to be inspected for particulate matter and discolouration. The clear to slightly opalescent and colourless to pale yellow solution must be free of visible particles.

A volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion is to be withdrawn and discarded from a 250 ml infusion bag equal to the total volume of Naglazyme to be added. 100 ml infusion bags should be considered for patients who are susceptible to fluid volume overload and weigh less than 20 kg; in this case the infusion rate (ml/min) should be decreased so that the total duration remains no less than 4 hours. When using 100 ml bags, the volume of Naglazyme may be added directly to the infusion bag.

The volume of Naglazyme is to be slowly added to the sodium chloride 9 mg/ml (0.9%) solution for infusion.

The solution is to be mixed gently for infusion.

The solution is to be visually inspected for particulate matter prior to use. Clear and colourless solutions without visible particles should be used.

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