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|Naglazyme

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GALSULFASE (Systemic)†

Some commonly used brand names are:

In the U.S.—

Naglazyme

† Not commercially available in Canada.

Description

Galsulfase (gal-SUL-face ) is used to treat mucopolysaccharidosis (MPS VI) disease caused by the lack of a certain enzyme called N-acetylgalactosamine 4-sulfatase in the body.

Galsulfase is available only with your doctor"s prescription, in the following dosage forms:

Parenteral
Injection (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For galsulfase, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to galsulfase. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Galsulfase has not been studied in pregnant women. However, galsulfase has not been shown to cause birth defects or other problems in animal studies.

Breast-feeding—It is not known whether galsulfase passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—This medicine has been tested in children 5 years of age and older and has not been shown to cause different side effects or problems than is does in adults. It is not known if children under 5 respond differently from older children.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of galsulfase in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Proper Use of This Medicine

Dosing—The dose of galsulfase will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of galsulfase.

For Mycopolysaccharidosis VI:
- For injection dosage form:
  - Adults and children—The dose is based on body weight and must be determined by your doctor. The usual dose is 1 milligrams (mg) per kilogram (kg), given once weekly. It is injected slowly into a vein over at least four hours.

Precautions While Using This Medicine

Regular visits: If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Blindness; blurred vision; chest pain; decreased vision; difficult or labored breathing; dizziness; headache; hernia of the naval; nervousness; pounding in the ears; shortness of breath; slow or fast heartbeat; swelling of the face; tightness in chest; wheezing

Frequency unknown

Bluish lips or skin; confusion; cough; dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly; facial swelling; fever or chills; hives or welts; itching; joint pain; large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs; nausea; noisy breathing; not breathing; pain behind the sternum; redness of skin; skin rash;; stomach pain; sweating; troubled breathing; vomiting

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

More common

Body produces substance that can bind to drug making it less effective or cause side effects; ear pain; stomach pain ; diarrhea; loss of appetite; pain

Less common

Body aches or pain; burning, dry or itching eyes; congestion; discharge; dryness or soreness of throat; excessive tearing; general feeling of discomfort or illness; hoarseness; loss of or increase in reflexes; redness, pain, swelling of eye, eyelid, or inner lining of eyelid; runny nose; stuffy nose; tender, swollen glands in neck ; trouble in swallowing; unusual tiredness or weakness; voice changes

Observed during clinical trials

Difficulty in moving; ear congestion; loss of voice; muscle pain or stiffness; nasal congestion; redness or swelling in ear; sneezing or sore throat

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 09/28/2005

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