Naglazyme

Generic Name: galsulfase (gal SUL fase)
Brand Name: Naglazyme

What is Naglazyme?

Naglazyme (galsulfase) is used to treat some of the symptoms of a genetic condition called mucopolysaccharidosis VI (MYOO-koe-pol-ee-SAK-a-rye-DOE-sis type 6), or MPS VI, also called Maroteaux-Lamy syndrome.

MPS VI is a metabolic disorder in which the body lacks the enzyme needed to break down certain sugars and proteins. These substances can build up in the body, causing enlarged organs, abnormal bone structure, changes in facial features, breathing problems, heart problems, vision or hearing loss, and changes in mental or physical abilities.

Naglazyme may improve walking and stair-climbing ability in people with this condition. However, this medication is not a cure for MPS VI.

Naglazyme may also be used for purposes not listed in this medication guide.

Important information

Some side effects may occur during the Naglazyme infusion, or up to 24 hours afterward. Tell your caregiver right away if you feel dizzy, light-headed, itchy, or if you have hives, chest pain, stomach pain, fever, trouble breathing, eye irritation, or swelling in your face.

Before receiving Naglazyme

You should not use Naglazyme if you are allergic to galsulfase.

To make sure Naglazyme is safe for you, tell your doctor if you have:

• asthma, or sleep apnea (breathing stops during sleep);

• fever, flu symptoms, or a common cold;

• kidney disease;

• heart disease;

• epilepsy; or

• migraine headaches.

FDA pregnancy category B. Naglazyme is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether galsulfase passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is Naglazyme given?

Naglazyme is injected into a vein through an IV. You will most likely receive this injection in a clinic or hospital setting.

Naglazyme must be given slowly through an IV infusion, and can take at least 4 hours to complete.

Your doctor may also prescribe other medications to help prevent an allergic reaction to galsulfase. Take all of your medications as directed.

Naglazyme is usually given once per week. Follow your doctor's instructions.

Your doctor will need to check your progress while you are using Naglazyme.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Naglazyme injection.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Naglazyme side effects

Some side effects may occur during the Naglazyme infusion, or up to 24 hours afterward. Tell your caregiver right away if you feel dizzy, light-headed, itchy, or if you have hives, chest pain, stomach pain, fever, trouble breathing, eye irritation, or swelling in your face.

Get emergency medical help if you have any of these signs of an allergic reaction to Naglazyme: hives; difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Even though it may not be a side effect of Naglazyme, increased pressure on the spinal cord is a complication of MPS VI that may occur while you are using this medicine. Tell your doctor right away if you have any symptoms of spinal cord compression: back pain, loss of movement in any part of your body, loss of bowel or bladder control.

Call your doctor at once if you have:

• snoring or sleep apnea, trouble breathing;

• shortness of breath (even with mild exertion);

• swelling, rapid weight gain;

• eye redness; or

• fever, chills, flu symptoms, pale skin, easy bruising or bleeding, unusual weakness.

Common Naglazyme side effects may include:

• pain;

• mild rash or itching;

• headache, ear pain, joint pain; or

• nausea, vomiting, stomach pain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Naglazyme?

Other drugs may interact with Naglazyme, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

• Your doctor or pharmacist can provide more information about Naglazyme.

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• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Naglazyme only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 2.01. Revision Date: 2013-05-13, 11:16:49 AM.