What is galsulfase used for?
- Galsulfase is used to treat mucopolysaccharidosis VI.
Before taking galsulfase, tell your doctor:
- If you are allergic to galsulfase; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
This medicine may interact with other drugs or health problems.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take galsulfase with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take galsulfase?
- Tell all of your health care providers that you take galsulfase. This includes your doctors, nurses, pharmacists, and dentists.
- Some people have had very bad allergic reactions during the infusion or within 24 hours of the infusion. Sometimes, these have been life-threatening. Talk with the doctor.
- Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
How is galsulfase best taken?
Use galsulfase as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- It is given as an infusion into a vein over a period of time.
- Other drugs may be given before galsulfase to help avoid side effects.
What do I do if I miss a dose?
- Call your doctor to find out what to do.
What are the side effects of galsulfase that I need to call my doctor about immediately?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
- Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
- Shortness of breath, a big weight gain, or swelling in the arms or legs.
- Chest pain or pressure.
- Fever or chills.
- Change in eyesight, eye pain, or very bad eye irritation.
- Change in hearing.
- Not able to move.
- Back pain.
- Not able to control bladder.
- Not able to control stools.
What are some other side effects of galsulfase?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Stomach pain.
- Joint pain.
- Ear pain.
- Upset stomach or throwing up.
- Nose or throat irritation.
- Feeling tired or weak.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
If overdose is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out galsulfase?
- If you need to store galsulfase at home, talk with your doctor, nurse, or pharmacist about how to store it.
Consumer information use and disclaimer
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else's drugs.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
- Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about galsulfase, please talk with your doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
This information should not be used to decide whether or not to take galsulfase or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to galsulfase. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.