Naglazyme

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

What is Naglazyme?

Naglazyme is used to treat some of the symptoms of a genetic condition called Maroteaux-Lamy syndrome. Maroteaux-Lamy syndrome is also called mucopolysaccharidosis type VI, a mucopolysaccharide enzyme deficiency.

Naglazyme may improve walking and stair-climbing ability in people with this condition. However, it is not a cure for Maroteaux-Lamy syndrome.

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

Important information about Naglazyme

Maroteaux-Lamy syndrome 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.

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Naglazyme may improve walking and stair-climbing ability in people with Maroteaux-Lamy syndrome. However, Naglazyme is not a cure for this condition. Some people receiving a Naglazyme injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you have a headache, fever or chills, skin rash, itching, nausea, vomiting, stomach pain, pain in your chest, trouble breathing, or if you feel like you might pass out when Naglazyme is injected.

Your name may need to be listed on a patient registry while you are using this medication. The purpose of this registry is to track the progression of this disorder and the effects that Naglazyme has on long-term treatment of Maroteaux-Lamy syndrome.

Before receiving Naglazyme

You should not use this medication if you are allergic to galsulfase or mouse proteins.

Before receiving Naglazyme, tell your doctor if you are allergic to any drugs, or if you have:

• sleep apnea (breathing stops during sleep);

• a fever; or

• flu symptoms, or a common cold.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use Naglazyme.

Your name may need to be listed on a patient registry while you are using this medication. The purpose of this registry is to track the progression of this disorder and the effects that Naglazyme has on long-term treatment of Maroteaux-Lamy syndrome.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Naglazyme passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

How is Naglazyme given?

Naglazyme is given as an injection through a needle placed into a vein. You will most likely receive this injection in a clinic or hospital setting. Naglazyme is usually given once per week.

The medicine must be given slowly through an IV infusion, and can take up to 4 hours to complete.

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

To be sure this medication is helping your condition and not causing harmful effects, your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

What happens if I miss a dose?

Contact your doctor if you miss an appointment for your Naglazyme injection.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

Symptoms of a Naglazyme overdose are not known.

What should I avoid while receiving Naglazyme?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are receiving Naglazyme.

Naglazyme side effects

Some people receiving a Naglazyme injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you have a headache, fever or chills, skin rash, itching, nausea, vomiting, stomach pain, pain in your chest, trouble breathing, or if you feel like you might pass out when Naglazyme is injected. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

• headache;

• joint pain;

• eye redness;

• nausea, vomiting, stomach pain, diarrhea;

• runny or stuffy nose, sore throat, cough, ear pain; or

• pain, redness, swelling, or other irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

See also: Naglazyme side effects (in more detail)

What other drugs will affect Naglazyme?

There may be other drugs that can interact with Naglazyme. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about Naglazyme.