Description
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.
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
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. Safety and efficacy have been established.
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.
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.
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
A nurse or other trained health professional will give you or your child this medicine in a hospital. This medicine is given through an IV catheter that is placed into one of your veins. This medicine must be given slowly, so the IV will remain in place for at least 4 hours. It is usually given once a week.
You or your child may also receive medicines (eg, allergy medicine, fever medicine) 30 to 60 minutes before starting treatment with this medicine.
Precautions
It is very important that your doctor check your or your child's progress closely while receiving this medicine to make sure that it is working properly. Blood and urine tests may be needed to check for unwanted effects.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you or your child have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, skin rash, trouble breathing, or unusual tiredness or weakness.
Check with your doctor right away if you have bloody or cloudy urine, high blood pressure, or swelling of the face, feet, or lower legs. These maybe symptoms of serious kidney problem.
This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child start to have a fever, chills or shaking, chest pain, dizziness, flushing, headache, trouble breathing, hives, itching, or skin rash, lightheadedness, fainting, fast, pounding, or uneven heartbeat, or trouble breathing after receiving this medicine.
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
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 or tightness
- difficult or labored breathing
- dizziness
- headache
- hernia of the naval
- nervousness
- pounding in the ears
- slow or fast heartbeat
- swelling of the face
Incidence not known
- Back pain
- black, tarry stools
- bleeding gums
- bloody or cloudy urine
- bluish lips or skin
- chills
- confusion
- cough
- difficulty swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fever
- hives, itching, skin rash
- 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
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- stomach pain
- swelling of the face, feet or lower legs
- sweating
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
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
- voice changes
Incidence not known
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- 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.
DRG-20067513
