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NAGLAZYME is a brand name for Galsulfase, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ......................................................................... 3 CONTRAINDICATIONS ............................................................................................. 4 WARNINGS AND PRECAUTIONS............................................................................. 4 ADVERSE…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations Naglazyme is intended for use under the supervision of a health professional in a clinical setting where resuscitation equipment to manage medical emergencies is readily available. Because of the potential for infusion reactions, patients should receive antihistamines with or without antipyretics prior to infusion and the infusion rate may be slowed and / or temporarily stopped, based on clinical judgment.
The safety and efficacy of Naglazyme in patients with hepatic or renal insufficiency have not been evaluated and no alternative dose regimen can be recommended in these patients. Recommended Dose and Dosage Adjustment 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 infusion should be delivered over a period of time of no less than four hours. The rate of infusion can be adjusted depending on body weight (see details in paragraphs below). 6%) patients required decreased infusion rate due to adverse events including infusion reactions.
No patients required increased intervals between doses due to adverse events. Each vial of Naglazyme provides 5 mg of galsulfase (expressed as protein content) in 5 mL of solution and is intended for single use only. Do not use the vial more than one time.
9% sodium chloride solution, USP, using aseptic techniques. 2 μm in-line filter. There is no information on the compatibility of diluted Naglazyme with glass containers. Pretreatment with antihistamines with or without antipyretics is recommended 30 to 60 minutes prior to the start of the infusion.
For Patients Weighing Greater than 20 kg The total volume of the infusion should be delivered over a period of time of no less than 4 hours. 9% sodium chloride solution, USP, to a final volume of 250 mL and delivered by controlled intravenous infusion using an infusion pump.
The initial infusion rate should be 6 mL per hour for the first hour. If the infusion is well tolerated, the rate of infusion may be increased to 80 mL per hour for the remaining 3 hours. The infusion time can be extended up to 20 hours if infusion reactions occur.
9% sodium chloride injection, USP. The infusion rate (mL per hour) should be decreased so that the total infusion duration remains no less than 4 hours. Administration Instructions for Use Prepare and use Naglazyme according to the following steps.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Use aseptic techniques. a. Determine the number of vials to be used based on the patient's weight and the recommended dose of 1 mg per kg: Patient's weight (kg) 1 mL / kg of Naglazyme = Total number of mL of Naglazyme Total number of mL of Naglazyme 5 mL per vial = Total number of vials Round up to the next whole vial.
Remove the required number of vials from the refrigerator to allow them to reach room temperature. Do not allow vials to remain at room temperature longer than 24 hours prior to dilution. Do not heat or microwave vials. b. Before withdrawing the Naglazyme solution from the vial, visually inspect each vial for particulate matter and discoloration.
The Naglazyme solution should be clear to slightly opalescent and colorless to pale yellow. Some translucency may be present in the solution. Do not use if the solution is discolored or if there is particulate matter in the solution.
c. 9% sodium chloride solution, USP, withdraw and discard a volume equal to the volume of Naglazyme solution to be added. If using a 100 mL infusion bag, this step is not necessary. d. Slowly withdraw the calculated volume of Naglazyme from the appropriate number of vials using caution to avoid excessive agitation.
Do not use a filter needle, as this may cause agitation. Agitation may denature Naglazyme, rendering it biologically inactive. e. 9% sodium chloride solution, USP, using care to avoid agitation of the solutions. Do not use a filter needle.
f. Gently rotate the infusion bag to ensure proper distribution of Naglazyme. Do not shake the solution. g. 2 μm in-line filter. Naglazyme®Galsulfase for injection) Product Monograph Page 13 of 28 Naglazyme does not contain preservatives; therefore, after dilution with saline, the infusion bags should be used immediately.
If immediate use is not possible, the diluted solution must be stored refrigerated at 2°C to 8°C and administered within 48 hours from the time of dilution to completion of administration. Other than during infusion, do not store the diluted Naglazyme solution at room temperature.
Naglazyme must not be infused with other products in the infusion tubing. The compatibility of Naglazyme in solution with other products has not been evaluated. OVERDOSAGE Several patients have received their total dose of Naglazyme at approximately twice the recommended infusion rate without apparent adverse events.
For management of a suspected drug overdose, contact your regional Poison Control Centre. ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action Mucopolysaccharide storage disorders are caused by the deficiency of specific lysosomal enzymes required for the catabolism of GAG.
MPS VI is characterized by the absence or marked reduction in N–acetylgalactosamine 4-sulfatase. The sulfatase activity deficiency results in the accumulation of the GAG substrate, […]