The recommended dosage regimen of ELAPRASE is 0.5 mg per kg of body weight administered once weekly as an intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
How to Calculate Each Patient’s Dose
- Determine the total volume of ELAPRASE (idursulfase) to be administered and the number of vials needed based on the patient’s weight and the recommended dose of 0.5 mg/kg.
- Patient’s weight (kg) x 0.5 mg per kg of ELAPRASE ÷ 2 mg per mL = Total # mL of ELAPRASE
- Total # mL of ELAPRASE ÷ 3 mL per vial = Total # of vials
- Round up to determine the number of whole vials needed.
Dose Calculation Example
Patient weight: 21.7 kg
|Step 1:||21.7 kg x 0.5 mg/kg = 10.85 mg|
|Step 2:||10.85 mg ÷ 2 mg/mL = 5.45 mL|
|Step 3:||5.45 mL ÷ 3 mL/vial = 1.8 vials (2 vials are used to withdraw a total volume of 5.4 mL)|
Required dose: 5.4 mL of ELAPRASE (from 2 vials) for a patient weighing 21.7 kg.