ELELYSO® Dosage and Administration

(taliglucerase alfa)

2 DOSAGE AND ADMINISTRATION

2.1 Pretreatment to Reduce Risk of Hypersensitivity Reactions

To reduce the risk of hypersensitivity reactions, consider pretreatment with antihistamines and/or corticosteroids [see Warnings and Precautions (5.1)].

2.2 Recommended Dosage in Patients 4 Years and Older

Treatment-naïve Patients 4 Years of Age and Older

The recommended dosage of ELELYSO is 60 units/kg (based on actual body weight) administered every other week as a 60- to 120-minute intravenous infusion.

Patients 4 Years of Age and Older Switching from Imiglucerase

If it is acceptable to switch from a stable imiglucerase dosage to ELELYSO, initiate ELELYSO intravenous treatment (60- to 120-minute infusion) with the same units/kg imiglucerase dosage and subsequently administer ELELYSO every other week. Dosage adjustments can be made based on achievement and maintenance of each patient's therapeutic goals.

2.3 Preparation Instructions

ELELYSO should be reconstituted, diluted, and administered under the supervision of a healthcare professional.

Prepare ELELYSO according to the following steps using aseptic technique:

a.
Determine the number of vials to be reconstituted based on the patient's weight in kg and the recommended dose [see Dosage and Administration (2.2)]. Round the number of vials up to the next whole number.
b.
Remove the required number of vials from the refrigerator. Do not leave these vials at room temperature longer than 24 hours prior to reconstitution. Do not heat or microwave these vials.
c.
Reconstitute each vial of ELELYSO with 5.1 mL of Sterile Water for Injection, USP to yield a reconstituted product with a concentration of 40 units/mL and an extractable volume of 5 mL.
(1)
Upon reconstitution, mix vials gently. DO NOT SHAKE.
(2)
Prior to further dilution, visually inspect the reconstituted solution in the vials for particulate matter and discoloration. The solution should be clear and colorless. Discard if particulate matter is present or the solution is discolored.
d.
Withdraw the calculated dose of drug from the appropriate number of vials and dilute with 0.9% Sodium Chloride Injection, USP, to a final volume of 100 to 200 mL. Discard any unused reconstituted solution.
(1)
For pediatric patients 4 years of age and older, use a final volume of 100 to 120 mL.
(2)
For adult patients, may use a final volume of 130 to 150 mL. However, if the volume of reconstituted product alone is equal to or greater than 130 to 150 mL, then the final volume should not exceed 200 mL.
e.
Mix the diluted solution gently. DO NOT SHAKE. Since this is a protein solution, slight flocculation (described as translucent fibers) occurs occasionally after dilution.
f.
Discard any unused diluted solution.

2.4 Storage and Handling of the Reconstituted and Diluted Solution

If the reconstituted ELELYSO vial is not used immediately, refrigerate at 2°°C to 8°°C (36°°F to 46°°F) for up to 24 hours (under protection from light) or store at controlled room temperature at 20°°C to 25 °C (68°°F to 77°°F) for up to 4 hours (without protection from light).
If the diluted solution is not administered immediately, refrigerate at 2 °C to 8 °C (36 °F to 46 °F) for up to 24 hours (under protection from light).
The total storage time for the reconstituted and diluted solution should not exceed 24 hours. Discard the unused reconstituted or diluted solution after 24 hours from the start of preparation.
Do not freeze.

2.5 Administration Instructions

After reconstitution and dilution, administer via intravenous infusion over a minimum of 60 minutes and with an in line low protein-binding 0.2 micron filter.

For pediatric patients who weigh (based on actual body weight):
o
Less than 30 kg use an infusion rate of 1 mL/minute.
o
Greater than or equal to 30 kg, use an initial infusion rate of 1 mL/minute. After tolerability to ELELYSO is established, may increase the infusion rate to a maximum of 2 mL/minute.
For adult patients, use an initial infusion rate of 1.2 mL/minute. After tolerability to ELELYSO is established, may increase the infusion rate to a maximum of 2.2 mL/minute.

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Pretreatment to Reduce Risk of Hypersensitivity Reactions

To reduce the risk of hypersensitivity reactions, consider pretreatment with antihistamines and/or corticosteroids [see Warnings and Precautions (5.1)].

2.2 Recommended Dosage in Patients 4 Years and Older

Treatment-naïve Patients 4 Years of Age and Older

The recommended dosage of ELELYSO is 60 units/kg (based on actual body weight) administered every other week as a 60- to 120-minute intravenous infusion.

Patients 4 Years of Age and Older Switching from Imiglucerase

If it is acceptable to switch from a stable imiglucerase dosage to ELELYSO, initiate ELELYSO intravenous treatment (60- to 120-minute infusion) with the same units/kg imiglucerase dosage and subsequently administer ELELYSO every other week. Dosage adjustments can be made based on achievement and maintenance of each patient's therapeutic goals.

2.3 Preparation Instructions

ELELYSO should be reconstituted, diluted, and administered under the supervision of a healthcare professional.

Prepare ELELYSO according to the following steps using aseptic technique:

a.
Determine the number of vials to be reconstituted based on the patient's weight in kg and the recommended dose [see Dosage and Administration (2.2)]. Round the number of vials up to the next whole number.
b.
Remove the required number of vials from the refrigerator. Do not leave these vials at room temperature longer than 24 hours prior to reconstitution. Do not heat or microwave these vials.
c.
Reconstitute each vial of ELELYSO with 5.1 mL of Sterile Water for Injection, USP to yield a reconstituted product with a concentration of 40 units/mL and an extractable volume of 5 mL.
(1)
Upon reconstitution, mix vials gently. DO NOT SHAKE.
(2)
Prior to further dilution, visually inspect the reconstituted solution in the vials for particulate matter and discoloration. The solution should be clear and colorless. Discard if particulate matter is present or the solution is discolored.
d.
Withdraw the calculated dose of drug from the appropriate number of vials and dilute with 0.9% Sodium Chloride Injection, USP, to a final volume of 100 to 200 mL. Discard any unused reconstituted solution.
(1)
For pediatric patients 4 years of age and older, use a final volume of 100 to 120 mL.
(2)
For adult patients, may use a final volume of 130 to 150 mL. However, if the volume of reconstituted product alone is equal to or greater than 130 to 150 mL, then the final volume should not exceed 200 mL.
e.
Mix the diluted solution gently. DO NOT SHAKE. Since this is a protein solution, slight flocculation (described as translucent fibers) occurs occasionally after dilution.
f.
Discard any unused diluted solution.

2.4 Storage and Handling of the Reconstituted and Diluted Solution

If the reconstituted ELELYSO vial is not used immediately, refrigerate at 2°°C to 8°°C (36°°F to 46°°F) for up to 24 hours (under protection from light) or store at controlled room temperature at 20°°C to 25 °C (68°°F to 77°°F) for up to 4 hours (without protection from light).
If the diluted solution is not administered immediately, refrigerate at 2 °C to 8 °C (36 °F to 46 °F) for up to 24 hours (under protection from light).
The total storage time for the reconstituted and diluted solution should not exceed 24 hours. Discard the unused reconstituted or diluted solution after 24 hours from the start of preparation.
Do not freeze.

2.5 Administration Instructions

After reconstitution and dilution, administer via intravenous infusion over a minimum of 60 minutes and with an in line low protein-binding 0.2 micron filter.

For pediatric patients who weigh (based on actual body weight):
o
Less than 30 kg use an infusion rate of 1 mL/minute.
o
Greater than or equal to 30 kg, use an initial infusion rate of 1 mL/minute. After tolerability to ELELYSO is established, may increase the infusion rate to a maximum of 2 mL/minute.
For adult patients, use an initial infusion rate of 1.2 mL/minute. After tolerability to ELELYSO is established, may increase the infusion rate to a maximum of 2.2 mL/minute.
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