July 29, 2016
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Naglazyme Patient Information including How Should I Take

What should I discuss with my health care provider before receiving galsulfase (Naglazyme)?

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

Before receiving galsulfase, 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 galsulfase.

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 galsulfase 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 galsulfase 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 galsulfase given (Naglazyme)?

Galsulfase 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. Galsulfase 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 galsulfase. 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.

Side Effects Centers

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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