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Naglazyme 1mg/ml Injection
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Indications & Clinical Uses
- Naglazyme (galsulfase) 1 mg/mL is an enzyme replacement therapy indicated for patients with Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome), a rare inherited metabolic disorder in which the enzyme N-acetylgalactosamine 4-sulfatase is missing or deficient, causing harmful build-up of glycosaminoglycans in tissues.
- Naglazyme has been shown to improve walking and stair-climbing capacity in people with MPS VI and is approved in both the United States and the European Union for this same rare-disease indication, in children and adults.
- It is given only as a weekly intravenous infusion by trained healthcare professionals in a hospital or infusion centre equipped to manage acute hypersensitivity reactions; it is never self-administered or given as an injection at home.
- Naglazyme does not cross the blood-brain barrier and does not treat the central nervous system features of MPS VI.
Side Effects
- Naglazyme carries a boxed warning for life-threatening hypersensitivity reactions, including anaphylaxis, which can occur during the infusion or up to several hours afterward, even in patients who have tolerated earlier infusions without problems; because of this, Naglazyme must be given in a setting with resuscitation equipment and staff trained to manage anaphylaxis immediately available.
- Very common reactions, affecting more than 1 in 10 people, include rash, pain, hives (urticaria), fever, itching, chills, headache, nausea, vomiting, abdominal pain and shortness of breath, most occurring as infusion-associated reactions despite premedication with antihistamines and antipyretics.
- Report facial or throat swelling, wheezing, chest tightness, a drop in blood pressure, or fainting immediately, as these can signal anaphylaxis; your infusion team will stop or slow the infusion and treat these reactions promptly if they occur.
Precautions & Warnings
- Because life-threatening hypersensitivity reactions and anaphylaxis have occurred with Naglazyme, even after many uneventful prior infusions, it must be given only where resuscitation equipment is immediately available, and patients are premedicated with antihistamines, with or without antipyretics, 30 to 60 minutes before each infusion; the rate is slowed or stopped for reactions and management may include further antihistamines, corticosteroids or epinephrine.
- Patients with compromised breathing, including sleep apnea or airway obstruction, need closer monitoring, since the premedication itself can add to apnoea risk; caution is also needed in patients susceptible to fluid overload from underlying heart or lung disease.
- Naglazyme has caused immune-mediated kidney reactions in some patients, so periodic monitoring is advised.
- Spinal or cervical cord compression is a known feature of MPS VI and should be assessed throughout treatment, independent of enzyme therapy.
- Store refrigerated at 2°C to 8°C, protected from light; do not freeze or shake, and use diluted solution within 48 hours if refrigerated.
Avoid Interactions
- No specific drug-drug interaction studies have been published for Naglazyme, and no clinically important pharmacokinetic interactions with other medicines have been identified in the prescribing information; even so, tell your healthcare team about every medicine, herbal product and supplement you take, since your MPS VI care may involve several specialists prescribing other treatments.
- Antihistamines given before each infusion to reduce the risk of a reaction can themselves cause drowsiness and, in people with sleep apnea or airway problems, can add to the risk of breathing pauses, so this combination is used cautiously and with monitoring.
- Naglazyme must be diluted only with 0.9% sodium chloride injection following the pharmacy's preparation instructions and must not be mixed or co-infused with other medicinal products in the same intravenous line.
- If you take any other regular medicines, including over-the-counter products, make sure your infusion centre has a complete, up-to-date list before each treatment visit.
References
Frequently Asked Questions
Naglazyme (galsulfase) is an enzyme replacement therapy for Mucopolysaccharidosis VI (MPS VI), a rare inherited disorder. It replaces the missing enzyme that normally breaks down certain sugars in the body and has been shown to improve walking and stair-climbing ability in people with MPS VI.
Naglazyme is given once a week as an intravenous infusion, always by trained healthcare staff in a hospital or infusion centre. It is never self-injected at home. A typical infusion runs over several hours, with your vital signs checked throughout.
Naglazyme has a boxed warning for life-threatening allergic reactions, including anaphylaxis, which can occur even after previous safe infusions. Very common effects include rash, hives, fever, headache, nausea and vomiting. Tell staff immediately about swelling, wheezing, chest tightness or dizziness during infusion.
You are given an antihistamine, sometimes with a fever-reducing medicine, 30 to 60 minutes before Naglazyme starts. The infusion is given slowly by staff who watch for allergic reactions and can slow, pause or treat the infusion promptly if a reaction develops.
Naglazyme must not be mixed with other medicines in the same infusion line; it is diluted only with saline. Tell your care team about all your other medicines, since antihistamines given before infusion can increase drowsiness, which matters if you also have sleep apnea.
Yes. Naglazyme is approved for MPS VI in both children and adults, and long-term weekly treatment is typically continued for life to manage this chronic genetic condition. Your specialist team monitors growth, joint mobility, breathing and organ function throughout treatment.
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