Pronunciation:

gal-SUL-fase

Brand Names:

• Naglazyme

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Enzyme

Uses of This Medicine:

Galsulfase injection is used to treat symptoms of an inherited disease called mucopolysaccharidosis (MPS VI) disease or Maroteaux-Lamy syndrome. This medicine improves walking and stair-climbing ability in patients who are lacking a certain enzyme called N-acetylgalactosamine 4-sulfatase in the body.

This medicine is to be given only by or under the direct supervision of a doctor.

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—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of galsulfase injection in children 5 years of age and older. Your doctor may choose to use this medicine in children younger than 5 years of age at their discretion.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of galsulfase injection in the geriatric population. Safety and efficacy have not been established.

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.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Fluid volume overload (increased volume of fluid in the body) or
• Heart disease or
• Lung disease or breathing problems—Use with caution. May increase risk for serious side effects.

• Sleep apnea—Use with caution. May make this condition worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

The usual dose schedule for this medicine is one time each week. This medicine must be given slowly, so the needle will remain in place for at least 4 hours.

You or your child may also receive medicines to help prevent possible allergic reactions to the injection.

Precautions While Using This Medicine:

If you will be using this medicine for a long time, it is very important that your doctor check you or your child at regular visits for any problems or unwanted effects that may be caused by this medicine.

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.

Tell your doctor right away if you have back pain, paralysis of the limbs, or loss of bladder or bowel control after receiving this medicine. These could be symptoms of a condition called spinal or cervical cord compression (SCC).

Your doctor may want you or your child to join a patient registry for patients using this medicine. This will help you monitor the progress of your disease while on long-term treatment using this medicine.

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 or nurse immediately if any of the following side effects occur:

Less common

Blurred or decreased vision

chest pain

difficult or labored breathing

dizziness

headache

hernia of the naval

nervousness

pounding in the ears

slow or fast heartbeat

swelling of the face

tightness in the chest

Incidence not known

Back pain

bluish lips or skin

confusion

cough

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fever, chills, or sweating

hives or welts

joint pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of bladder control

loss of bowel control

nausea or vomiting

paralysis of the limbs

stomach pain

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

Diarrhea

ear pain

loss of appetite

Less common

Body aches or pain

burning, dry, or itching eyes

congestion

dryness or soreness of the throat

excessive tearing

loss of or increase in reflexes

runny or stuffy nose

tender, swollen glands in the neck

trouble with swallowing

unusual tiredness or weakness

voice changes

Incidence not known

Difficulty with moving

loss of voice

muscle pain or stiffness

sneezing

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.