Dosing and Administration
Administration of Lumizyme should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis
- Initiate Lumizyme in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment
- Prior to Lumizyme administration, consider pretreating with antihistamines, antipyretics, and/or corticosteroids
- Lumizyme must be reconstituted and diluted prior to use
- Appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment, should be readily available during Lumizyme administration
- If one or more doses are missed, restart Lumizyme treatment as soon as possible, maintaining the 2-week interval between infusions thereafter
Calculating Dosages
A patient's dose and the vials required for that dose can be calculated with the following formulas:
- Lumizyme dose in mg=Patient weight in kg × 20 mg/kg
- Number of vials to be reconstituted=Lumizyme dose in mg ÷ 50 mg/vial (round result up to next whole number)
For example, if a patient weighs 68 kg:
- Lumizyme dose in mg=68 kg × 20 mg/kg=1,360 mg
- Number of vials to be reconstituted=1,360 mg ÷ 50 mg/vial=27.2 vials, rounded up=28 vials
Actual body weight was used as the basis for dosing in Lumizyme clinical trials. Physicians who have questions about dosing should contact Sanofi Medical Information (800-745-4447, option 2).
Reconstitution & Dilution
Lumizyme is supplied as a sterile, nonpyrogenic, white to off-white lyophilized cake or powder that must first be reconstituted before administration. For reconstitution and dilution instructions, see Section 2.3 of the Full Prescribing Information.
Administering Infusions
Administer Lumizyme using an in-line low protein binding 0.2-micron filter. These filters are NOT provided in the product package.
Lumizyme should not be infused in the same intravenous line with other products, and the solution should be protected from light.
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Recommended Infusion Volumes and Rates
Infusions should be administered in a step-wise manner using an infusion pump. The initial infusion rate should be no more than 1 mg/kg/hr. The infusion rate may be increased by 2 mg/kg/hr every 30 minutes, after patient tolerance to the infusion rate is established, until a maximum rate of 7 mg/kg/hr is reached. Vital signs should be obtained at the end of each step. If the patient is stable, Lumizyme may be administered at the maximum rate of 7 mg/kg/hr until the infusion is completed.
Consult the following chart for infusion rates at each step:
Patient WeightRange |
Total InfusionVolume |
Step 1
|
Step 2
|
Step 3
|
Step 4
|
| 1.25 - 2.5 | 25 | 1.25 | 3.75 | 6.25 | 6.6 |
| 2.6 - 10 | 50 | 3 | 8 | 13 | 18 |
| 10.1 - 20 | 100 | 5 | 15 | 25 | 35 |
| 20.1 - 30 | 150 | 8 | 23 | 38 | 53 |
| 30.1 - 35 | 200 | 10 | 30 | 50 | 70 |
| 35.1 - 50 | 250 | 13 | 38 | 63 | 88 |
| 50.1 - 60 | 300 | 15 | 45 | 75 | 105 |
| 60.1 - 100 | 500 | 25 | 75 | 125 | 175 |
| 100.1 -120 | 600 | 30 | 90 | 150 | 210 |
| 120.1 - 140 | 700 | 35 | 105 | 175 | 245 |
| 140.1 - 160 | 800 | 40 | 120 | 200 | 280 |
| 160.1 - 180 | 900 | 45 | 135 | 225 | 315 |
| 180.1 - 200 | 1000 | 50 | 150 | 250 | 350 |
Additional Infusion Considerations1
Hypersensitivity reactions including anaphylaxis have been observed in patients during and up to 3 hours after a Lumizyme infusion.
- If a severe hypersensitivity reaction (eg, anaphylaxis) occurs, discontinue Lumizyme and immediately initiate appropriate medical treatment, including use of epinephrine
- If a mild or moderate hypersensitivity reaction occurs, consider temporarily holding the Lumizyme infusion or slowing the infusion rate
- Consider the risks and benefits of readministering Lumizyme following a hypersensitivity reaction including anaphylaxis. Patients may be rechallenged using slower infusion rates at a lower dosage than the recommended dosage
Indication
Reference: Lumizyme (alglucosidase alfa). Prescribing information. Genzyme Corporation, Cambridge, MA.
