NAGLAZYME 5 mg/5mL
galsulfase · SOLUTION · BioMarin Pharmaceutical Inc.
Naglazyme (galsulfase) is an intravenous enzyme replacement therapy used to treat mucopolysaccharidosis VI (MPS VI), a rare genetic disorder in which the body cannot break down certain complex sugars. This medication helps reduce the buildup of these substances in the body to improve symptoms and slow disease progression.
Key Facts
- Brand Name
- NAGLAZYME
- Generic Name
- galsulfase
- NDC Code (Product)
68135-020- Manufacturer
- BioMarin Pharmaceutical Inc.
- Strength
- 5 mg/5mL
- Dosage Form
- SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA125117
- Drug Class
- Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]
- Marketing Start
- 06/09/2005
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE NAGLAZYME is indicated for patients with Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome). NAGLAZYME has been shown to improve walking and stair-climbing capacity. NAGLAZYME is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients with Mucopolysaccharidosis VI (MPS VI; Maroteaux-Lamy syndrome). NAGLAZYME has been shown to improve walking and stair-climbing capacity. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administration of NAGLAZYME should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis. ( 2.1 ) The recommended dosage is 1 mg per kg of body weight administered once weekly as an intravenous infusion. ( 2.2 ) 2.1 Recommendations Prior to NAGLAZYME Treatment Administration of NAGLAZYME should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis [see Warnings and Precautions (5.1) ] . Initiate NAGLAZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment [see Warnings and Precautions (5.1) ] . Pretreatment with antihistamines with or without antipyretics is recommended 30 to 60 minutes prior to the start of the infusion [see Warnings and Precautions (5.5) ]. 2.2 Recommended Dosage and Administration The recommended dosage regimen of NAGLAZYME is 1 mg per kg of body weight administered once weekly as an intravenous infusion. The total volume of the infusion should be delivered over a period of time of no less than 4 hours. NAGLAZ…
Contraindications
4 CONTRAINDICATIONS None. None. (4)
Adverse Reactions
6 ADVERSE REACTIONS Serious and/or clinically significant adverse reactions described elsewhere in labeling include: Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions ( 5.1 )] Immune-Mediated Reactions [see Warnings and Precautions ( 5.2 )] Risk of Acute Cardiorespiratory Failure [see Warnings and Precautions ( 5.2 )] Acute Respiratory Complications Associated with Administration [see Warnings and Precautions ( 5.4 )] Infusion Reactions [see Warnings and Precautions ( 5.5 )] Spinal or Cervical Cord Compression [see Warnings and Precautions ( 5.6 )] The most common adverse reactions (≥10%) are: rash, pain, urticaria, pyrexia, pruritus, chills, headache, nausea, vomiting, abdominal pain and dyspnea. The most common adverse reactions requiring interventions are infusion-related reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact: BioMarin Pharmaceutical Inc. at 1-866-906-6100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates observed in the c…
Frequently Asked Questions
What is NAGLAZYME used for?
Naglazyme (galsulfase) is an intravenous enzyme replacement therapy used to treat mucopolysaccharidosis VI (MPS VI), a rare genetic disorder in which the body cannot break down certain complex sugars. This medication helps reduce the buildup of these substances in the body to improve symptoms and slow disease progression.
Is NAGLAZYME a controlled substance?
NAGLAZYME is not classified as a controlled substance by the DEA.
What is the generic name for NAGLAZYME?
The generic name for NAGLAZYME is galsulfase. There are no other listed brand versions of galsulfase.
What is the NDC code for NAGLAZYME 5 mg/5mL?
The NDC (National Drug Code) for NAGLAZYME 5 mg/5mL is 68135-020, listed by BioMarin Pharmaceutical Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)