Galsulfase (Injection)

Introduction

Galsulfase (gal-SUL-fase)

Improves walking and stair-climbing ability in people with an enzyme deficiency called mucopolysaccharidosis VI (MPS VI), which can affect certain tissues in the body.

Brand Name(s)

Naglazyme

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not receive this medicine if you have had an allergic reaction to galsulfase.

How to Use This Medicine

Injectable

  • Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins.
  • A nurse or other trained health professional will give you this medicine.
  • The usual dose schedule for this medicine is one time each week. The medicine must be given slowly, so the needle will remain in place for at least 4 hours. An IV pump is sometimes used if the medicine needs to be given over several hours or throughout an entire day.
  • You may also receive medicines to help prevent possible allergic reactions to the injection.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine

  • Make sure your doctor knows if you are pregnant or breastfeeding, or if you have heart disease, lung disease, breathing problems, or an increased volume of fluid in the body. Tell your doctor if you snore or if you have sleep apnea.
  • This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have dizziness; lightheadedness; a rash; itching; hoarseness; trouble breathing or swallowing; or any swelling of your hands, face, or mouth while you or your child are using this medicine.
  • This medicine may cause headaches and skin reactions, such as a rash or itching, while you are receiving the injection or within 24 hours after you receive it. Check with your doctor or nurse right away if you or your child have any of these symptoms.
  • This medicine can cause fever and allergic-type reactions. You or your child will receive medicines to prevent these side effects, and that medicine may make you drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
  • Your doctor may want you or your child to join a patient registry for patients taking this medicine. This will help you monitor the progress of your disease while on long-term treatment using this medicine.
  • Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Chest pain.
  • Fast, slow, or pounding heartbeat.
  • Feeling very drowsy or sleepy.
  • Fever or chills.
  • Lightheadedness, dizziness, or fainting.
  • Shortness of breath, troubled breathing, or breathing that stops during sleep.

If you notice these less serious side effects, talk with your doctor:

  • Blurred vision.
  • Cough, sore throat, ear pain, or runny or stuffy nose.
  • Diarrhea, nausea, vomiting, or stomach pain or upset.
  • Headache.
  • Joint or muscle pain.
  • Mild skin rash.
  • Redness in your eyes.
  • Tiredness.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Version Info

  • Last Reviewed on 06/12/2013

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This page was last updated: June 18, 2013

         
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