Uses

Galsulfase is used to treat a certain rare genetic problem (Maroteaux-Lamy syndrome - MLS). Galsulfase replaces a certain natural substance that is missing in people with MLS.This medication improves how far you can walk and the number of stairs you can climb up. Galsulfase does not correct the genetic problem, and treatment must be continued for life.

How to use Naglazyme Vial

This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor, usually once a week. It is injected slowly into a vein over 4 hours. The dosage is based on your weight, medical condition, and response to treatment.

Infusion reactions may happen during the infusion of this drug. Your doctor may prescribe other medications (such as antihistamines, drugs for fever) before each treatment to help prevent these side effects. Tell your doctor right away if you have any symptoms of infusion reactions such as fever, chills, shortness of breath, nausea/vomiting, increased blood pressure, headache, chest pain, dizziness, weakness/tiredness, joint pain, flushing, or coughing. Your doctor may give you other medications to help with these side effects or may slow down or stop your treatment for some time.

Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day each week.

Tell your doctor if your condition gets worse.

Side Effects

See also Warning and How to Use sections.

Ear pain, eye redness/itching/discharge, or stomach/abdominal pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: vision/hearing changes, back pain, inability to move arms/legs, inability to control urine/stool, signs of kidney problems (such as change in the amount of urine).

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Warnings

Galsulfase may cause serious (sometimes fatal) allergic reactions during the infusion of this drug and for 24 hours afterward. Get medical help right away if you have any symptoms of a serious allergic reaction such as rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, or trouble breathing.

Precautions

Before using galsulfase, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as heart failure), lung problems.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

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Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Notes Notes

Keep all medical and lab appointments.

Missed Dose Missed Dose

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Storage Storage

Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.