FABRAZYME ® 5MG (AGALSIDASE BETA)

GENZYME IRELAND LIMITED (FILL-FINISH) (IRELAND)🇸🇬 Health Sciences Authority

Approval Date: Mar 10, 2009
Approval ID: 5ba74ba4a22868e0
Company: GENZYME IRELAND LIMITED (FILL-FINISH) (IRELAND)
Type: Therapeutic

Approval Details

Approval Id: 5ba74ba4a22868e0
Drug Name: FABRAZYME ® 5MG (AGALSIDASE BETA)
Product Name: FABRAZYME ® 5MG (AGALSIDASE BETA)
Approval Number: SIN13610P
Approval Date: 2009-03-10
Registrant: SANOFI-AVENTIS SINGAPORE PTE. LTD.
Licence Holder: SANOFI-AVENTIS SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INJECTION, POWDER, FOR SOLUTION
Dosage: 2 DOSAGE AND ADMINISTRATION 2.1 Recommendations Prior to FABRAZYME Treatment <ul> <li>Administration of FABRAZYME should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis [see Warnings and Precautions (5.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].</li> <li>Initiate FABRAZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment [see Warnings and Precautions (5.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].</li> <li>Prior to FABRAZYME administration, consider pretreating with antihistamines, antipyretics, and/or corticosteroids [see Warnings and Precautions (5.1, 5.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].</li> <li>FABRAZYME must be reconstituted and diluted prior to use [see Dosage and Administration (2.4)]</li> </ul> 2.2 Recommended Dosage <ul> <li>The recommended dosage of Fabrazyme is 1 mg/kg body weight infused every two weeks as an intravenous infusion. The initial intravenous infusion rate is no more than 0.25 mg/min (15 mg/hour). Slow the infusion rate in the event of infusion-associated reactions [see Warnings and Precautions (5.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].</li> <li>Administer antipyretics prior to infusion of Fabrazyme [see Warnings and Precautions (5.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].</li> <li>After patient tolerance to the infusion is well established, increase the infusion rate in increments of 0.05 to 0.08 mg/min (increments of 3 to 5 mg/hour) with each subsequent infusion.</li> <li>The maximum infusion rate for patients weighing less than 30 kg, is 0.25 mg/minute (15 mg/hour).</li> <li>For patients weighing 30 kg or greater, the minimum infusion duration is 1.5 hours (based on individual patient tolerability).</li> </ul> 2.3 Rechallenge Instruction <ul> <li>Patients who have had a positive skin test to Fabrazyme or who have tested positive for anti- Fabrazyme IgE may be successfully rechallenged with Fabrazyme. The initial rechallenge administration should be a low dose at a lower infusion rate, e.g., 1/2 the therapeutic dose (0.5 mg/kg) at 1/25th the initial standard recommended rate (0.01 mg/min or 0.6 mg/hr). Once a patient tolerates the infusion, the dose may be increased to reach the approved dose of 1 mg/kg and the infusion rate may be increased by slowly titrating upwards (doubled every 30 minutes up to a maximum rate of 0.25 mg/minute), as tolerated [see Adverse Reactions (6.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].</li> </ul> 2.4 Preparation and Administration Instructions Fabrazyme does not contain any preservatives. Vials are for single use only. Discard any unused product. Avoid shaking or agitating this product. Do not use filter needles during the preparation of the infusion. Reconstitution and Dilution (using Aseptic Technique) <ol> <li>Allow Fabrazyme vials and diluent to reach room temperature prior to reconstitution (approximately 30 minutes). The number of 35 mg and 5 mg vials needed is based on the patient’s body weight (kg) and the recommended dose of 1 mg/kg. Select a combination of 35 mg and 5 mg vials so that the total number of mg is equal to or greater than the patient’s number of kg of body weight.</li> <li>Reconstitute each 35 mg vial of Fabrazyme by slowly injecting 7.2 mL of Sterile Water for Injection, USP down the inside wall of each vial. Roll and tilt each vial gently. Each vial will yield a 5 mg/mL clear, colorless solution (total extractable amount per vial is 35 mg, 7 mL). Reconstitute each 5 mg vial of Fabrazyme by slowly injecting 1.1 mL of Sterile Water for Injection, USP down the inside wall of each vial. Roll and tilt each vial gently. Each vial will yield a 5 mg/mL clear, colorless solution (total extractable amount per vial is 5 mg, 1 mL).</li> <li>Visually inspect the reconstituted vials for particulate matter and discoloration. Do not use the reconstituted solution if there is particulate matter or if it is discolored.</li> <li>The reconstituted solution should be further diluted with 0.9% Sodium Chloride Injection, USP to a total volume based on patient weight specified in Table 1 below. Prior to adding the volume of reconstituted Fabrazyme required for the patient dose, remove an equal volume of 0.9% Sodium Chloride Injection, USP from the infusion bag. <img src="/TGIF/Fabrazyme-Table1_140425.png" alt="Fabrazyme Dosage Table 1" /> Patient dose (in mg) ÷ 5 mg/mL = Number of mL of reconstituted Fabrazyme required for patient dose Example: Patient dose = 80 mg 80 mg ÷ 5 mg/mL = 16 mL of Fabrazyme Slowly withdraw the reconstituted solution from each vial up to the total volume required for the patient dose. Inject the reconstituted Fabrazyme solution directly into the Sodium Chloride solution. Do not inject in the airspace within the infusion bag. Discard any vial with unused reconstituted solution.</li> <li>Gently invert infusion bag to mix the solution, avoiding vigorous shaking and agitation.</li> <li>Do not infuse Fabrazyme in the same intravenous line with other products.</li> <li>Administer Fabrazyme using an in-line low protein binding 0.2 micrometre filter.</li> </ol> 2.5 Storage Instructions for the Reconstituted and Diluted Product Use reconstituted and diluted solutions of Fabrazyme immediately. If immediate use is not possible, the reconstituted and diluted solution may be stored for up to 24 hours at 2°C to 8°C (36°F to 46°F).
Route Of Administration: INTRAVENOUS
Indication Info: 1 INDICATIONS AND USAGE FABRAZYME is indicated for use in patients with Fabry disease. FABRAZYME reduces globotriaosylceramide (GL-3) deposition in capillary endothelium of the kidney and certain other cell types.
Contraindications: 4 CONTRAINDICATIONS None.
Atc Code: A16AB04
Atc Item Name: agalsidase beta
Pharma Manufacturer Name: SANOFI-AVENTIS SINGAPORE PTE. LTD.
Company Detail Path: /organization/sanofi-aventis-singapore-pte-ltd

Active Ingredients

Agalsidase beta

5.5mg/5mg vial

AGALSIDASE BETA

5.5 MG/5 MG VIAL

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Mar 10, 2009

Approval ID

5ba74ba4a22868e0

Type

Therapeutic

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