galsulfase Intravenous

gal-SUL-fase

Commonly used brand name(s)

In the U.S.

• Naglazyme

Available Dosage Forms:

• Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Enzyme

Uses For galsulfase

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

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

Before Using galsulfase

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 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

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 medication in children under the age of 5 at their discretion.

Geriatric

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.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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 galsulfase. 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 galsulfase

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

The usual dose schedule for galsulfase is one time each week. galsulfase 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 galsulfase

If you will be taking galsulfase 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 galsulfase.

galsulfase 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 with breathing or swallowing; or any swelling of your hands, face, or mouth while you or your child are using galsulfase.

galsulfase 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.

galsulfase 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.

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

galsulfase Side Effects

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

• 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 the chest


• wheezing

Incidence not known

• Bluish lips or skin


• confusion


• cough


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


• fever or chills


• hives or welts


• itching


• joint pain


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


• nausea


• noisy breathing


• not breathing


• pain behind the sternum or breastbone


• redness of the 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


• diarrhea


• ear pain


• loss of appetite


• pain


• stomach pain

Less common

• Body aches or pain


• burning, dry, or itching eyes


• congestion


• discharge


• dryness or soreness of the throat


• excessive tearing


• general feeling of discomfort or illness


• hoarseness


• loss of or increase in reflexes


• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid


• 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


• ear congestion


• loss of voice


• muscle pain or stiffness


• nasal congestion


• redness or swelling in the ear


• 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.

See also: galsulfase Intravenous side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More galsulfase Intravenous resources

• Galsulfase Intravenous Side Effects (in more detail)
• Galsulfase Intravenous Use in Pregnancy & Breastfeeding
• Galsulfase Intravenous Support Group
• 0 Reviews for Galsulfase Intravenous - Add your own review/rating

Compare galsulfase Intravenous with other medications

• Mucopolysaccharidosis Type VI