- Brand name
- Naglazyme Concentrate for infusion
- Active ingredient
Consumer medicine information (CMI) leaflet
Please read this leaflet carefully before you start using Naglazyme Concentrate for infusion.Download CMI (PDF) Download large text CMI (PDF)
WHAT IS THIS LEAFLET
This leaflet answers some common questions about Naglazyme.
It does not contain all the available information.
It does not take the place of talking to your doctor or a trained health care professional.
All medicines have risks and benefits. Your doctor has weighed the risks of having Naglazyme against the benefits they expect it will have.
If you have any concerns about this medicine, ask your doctor or health care professional.
Keep this leaflet
You may find you need to read it again.
WHAT NAGLAZYME IS USED FOR
Naglazyme is used as an enzyme replacement therapy in patients with Mucopolysaccharidosis VI (MPS VI) storage disorder, a disease in which the enzyme level of N-acetylgalactosamine 4-sulfatase is absent or lower than normal.
How it works
Patients with MPS VI disease do not produce enough of their own enzyme, N-acetylgalactosamine 4-sulfatase. The reduced or absent N- acetylgalactosamine 4-sulfatase activity in patients results in the accumulation of substances called glycosaminoglycans (GAGs) in many tissues in the body.
This medicine contains a recombinant enzyme called galsulfase-rch. 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 GAG in the body. This medicine may improve the symptoms of MPS VI.
BEFORE NAGLAZYME ADMINISTRATION
Naglazyme should not be given if you have experienced severe or life-threatening allergic (hypersensitive) reactions to galsulfase-rch or any of the other ingredients of Naglazyme listed at the end of this CMI and re-administration of the medicine was not successful.
If you are treated with Naglazyme, you may develop infusion reactions. An infusion reaction is any side effect occurring during the infusion or shortly after (refer to Side Effects section). When you experience such a reaction, you should immediately contact your health care professional.
MPS VI disease can cause pressure on the upper spinal cord, which can occur while you are receiving Naglazyme. Please talk to your health care professional if you experience muscle pain, numbness in your arms or legs, or any bowel or bladder problems.
BEFORE Naglazyme administration, talk to your health care professional if:
- you have a fever, or if you are having difficulty breathing before this medicine is given.
- you have kidney or liver insufficiency. This medicine has not been tested in patients with kidney or liver problems.
- you are pregnant or intend to become pregnant or are breastfeeding.
Naglazyme should not be given during pregnancy unless clearly necessary. Ask your doctor or health care professional for advice before taking any medicine. It is not known whether galsulfase-rch is excreted in milk, therefore breast-feeding should be stopped during Naglazyme treatment.
Taking other medicines
Tell your doctor or health care professional if you are taking any other medicines, including any that you buy without prescription from your pharmacy, supermarket or health food shop.
Interaction studies with Naglazyme have not been conducted.
HOW NAGLAZYME IS ADMINISTERED
Naglazyme is administered once a week directly into the vein (intravenously) by a trained health care professional in a hospital or a clinic.
Your doctor or health care professional will decide on the dose that is most suitable.
An antihistamine may be administered prior to infusion of Naglazyme to minimise possible infusion reactions.
If you are given too much (overdose)
Naglazyme is administered under the supervision of a health care professional. He or she will check that the correct dose has been given and act accordingly if necessary.
Things you must do
Keep appointments with your doctor or clinic.
It is important to have the Naglazyme infusion at the appropriate time to make sure the medicine has the best chance of providing treatment for the condition.
Tell your doctors, dentists and pharmacists who treat you that you are taking this medicine.
AFTER HAVING NAGLAZYME INFUSION
Things to be careful of
Be careful driving or operating machinery until you know how Naglazyme affects you.
The effect of Naglazyme on your ability to drive a car or operate machinery has not been studied. Make sure you know how you react to Naglazyme before you drive a car or operate machinery.
Tell your doctor or health care professional as soon as possible if you do not feel well while you are taking Naglazyme.
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 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); swelling of the tongue and throat, and serious allergic reaction to this medicine (unknown frequency).
If you experience any reaction like this, tell your health care professional 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 reactions include fever, chills, rash, hives and shortness of breath.
This is not a complete list of side effects. For any unexpected effects while taking Naglazyme, contact your doctor or health care professional.
Naglazyme will be stored under refrigeration (2°C - 8°C) in the hospital or pharmacy.
What it looks like
Naglazyme is a colourless to pale yellow, clear to slightly opalescent solution contained in a labelled 5 mL glass vial. Each vial contains 5 mg/ 5 mL galsulfase-rch.
Active Ingredient: N-acetylgalactosamine 4-sulfatase (galsulfase-rch)
Other Ingredients: sodium chloride, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate, polysorbate 80 and water for injection.
In Australia this product is registered by:
BioMarin Pharmaceutical Australia Pty Ltd,
119 Willoughby Rd, Crows Nest,
NSW 2065, Australia
AUST R 125598
For enquiries about Naglazyme, please call BioMarin on (02) 8520 3255 or 0011 800 7424 6627 (international toll free number) or email@example.com
To report adverse events, contact firstname.lastname@example.org or call 0011 800 7424 6627 (international toll free number).
Naglazyme is manufactured by BioMarin Pharmaceutical Inc., USA
Naglazyme is a trademark of BioMarin Pharmaceutical Inc., USA
This leaflet was prepared in September 2015.