Naglazyme

This product is available in the following dosage forms:

• Solution

Before Using

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.

Pediatric

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.

Geriatric

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

Breastfeeding

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.

Drug Interactions

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

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 childrena€”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

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

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.