Pronunciation:

gal-SUL-fase

Brand Names:

• Naglazyme

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Enzyme

Uses of This Medicine:

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

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

Pregnancy—

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

Dosing—

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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:

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

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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