Naglazyme (Galsulfase) belongs to the class of medications called enzyme replacement therapies. It is used to treat the condition known as mucopolysaccharidosis VI (MPS VI), which is also called Maroteaux-Lamy syndrome.
Available form
Injectable
Dosage
Manufacturer
Biomarin International
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The recommended adult dose of Naglazyme (Galsulfase) is calculated as 1 mg per kilogram of body weight. It is given intravenously (into a vein) over at least 4 hours, once a week.
Very careful handling of Naglazyme (Galsulfase) is required, and it is always given in a hospital or similar setting with access to sterile equipment for preparation.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. It is important this medication be given exactly as recommended by your doctor. If you miss an appointment to receive Naglazyme (Galsulfase), contact your doctor as soon as possible to reschedule your appointment.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes Naglazyme (Galsulfase). If you are concerned about side effects, discuss the risks and benefits of Naglazyme (Galsulfase) with your doctor.
The following side effects have been reported by at least 1% of people taking Naglazyme (Galsulfase). Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Stop taking the medication and seek immediate medical attention if any of the following occur:
Some people may experience side effects other than those listed.Check with your doctor if you notice any symptom that worries you while you are taking Naglazyme (Galsulfase).
Each mL of sterile, colourless-to-pale-yellow, clear-to-slightly-opalescent solution contains 1 mg of Naglazyme (Galsulfase) (expressed as protein content). Nonmedicinal ingredients: polysorbate 80, sodium chloride, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, and water for injection.
Do not take Naglazyme (Galsulfase) if you are allergic to Naglazyme (Galsulfase) or any ingredients of the medication.
Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with Naglazyme (Galsulfase). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Naglazyme (Galsulfase).
Allergic reactions: Some people may develop a serious allergic reaction to Naglazyme (Galsulfase). This reaction can occur up to 24 hours after receiving a dose of Naglazyme (Galsulfase). Signs of an allergic reaction include a severe rash, hives, swollen face or throat, or difficulty breathing. If these occur, get immediate medical attention.
Infusion-related reactions: As with other enzyme therapies, Naglazyme (Galsulfase) can cause severe infusion-related reactions, including severe allergic reactions. Your health care provider will closely monitor you during and after the infusion, and may give you other medications before you receive the Naglazyme (Galsulfase), to prevent these reactions.
If you experience symptoms of an infusion reaction, such as fever, chills, difficulty breathing, tightness of chest or throat, stomach upset, and rash, tell your health care provider immediately. Symptoms can usually be reduced by slowing down or temporarily stopping the medication, as well as using other medications, to treat the reaction.
It is important to take the medication(s) recommended by your doctor before your infusion of Naglazyme (Galsulfase). If you experience a severe infusion reaction, your doctor will give you additional medications to treat the reaction. Ask your doctor for more information.
Spinal cord compression: Maroteaux-Lamy syndrome often causes pressure on the spinal cord. This is normal in the progression of the illness, however it may develop or become worse with the use of Naglazyme (Galsulfase). Report any symptoms of back pain, paralysis, or being unable to hold urine or stools to your doctor immediately. These are possible symptoms of compression of the spinal cord and may become a medical emergency if not treated as soon as possible.
Pregnancy: Naglazyme (Galsulfase) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Naglazyme (Galsulfase), contact your doctor immediately.
Breast-feeding: It is not known if Naglazyme (Galsulfase) passes into breast milk. If you are a breast-feeding mother and are taking Naglazyme (Galsulfase), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Seniors: The safety and effectiveness of using Naglazyme (Galsulfase) have not been established for seniors. Clinical trials treated people less than 30 years of age.
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