In-office dosing and administration
Lyophilized powder for in-office reconstitution and administration
.jpg?auto=format "lyophilized-powder-vial")
Consider in-office administration for patients aged 6 and older or choose at-home administration for appropriate patients aged 12 and older.
- Recommended dose is 100 mg
- Administer 1 mL of the reconstituted solution
- Fixed dose independent of weight
- NUCALA lyophilized powder should be administered by a healthcare professional
- SC injection every 4 weeks into the upper arm, thigh, or abdomen
- In line with clinical practice, monitoring of patients after administration of biologic agents is recommended
Ensure you have everything you need to reconstitute NUCALA:
- 1 vial of NUCALA
- Sterile Water (1.2 mL) for Injection, USP
- A syringe (preferably 2 to 3 mL)
- A needle (preferably 21 gauge)
Withdraw 1.2 mL of Sterile Water for Injection into the syringe.
Direct the stream of Sterile Water for Injection vertically onto the center of the lyophilized cake.
Gently swirl the vial for 10 seconds with circular motion at 15-second intervals until the powder is dissolved.*
DO NOT SHAKE the reconstituted solution during the procedure because this may lead to product foaming or precipitation.
INSPECT the reconstituted solution. If particulate matter remains in the solution or if it appears cloudy or milky, the solution must not be administered.†
Manual reconstitution is typically complete ~5 minutes after the water has been added.
*If a mechanical reconstitution device (swirler) is used to reconstitute NUCALA, swirl at 450 rpm for no longer than 10 minutes. Alternatively, swirling at 1000 rpm for no longer than 5 minutes is acceptable.
†The solution should be clear to opalescent, and colorless to pale yellow or pale brown, essentially particle free. Small air bubbles, however, are expected and acceptable.
SC=subcutaneous.
Pediatric dosing and administration
The recommended dose of NUCALA in children aged 6 to 11 years is 40 mg subcutaneous (SC) administered once every 4 weeks. Administer 0.4 mL of the reconstituted solution.
- NUCALA lyophilized powder should be reconstituted and administered by a healthcare professional. Follow the instructions in the Prescribing Information for reconstitution.
- Remove 0.4 mL of reconstituted NUCALA (equivalent to 40 mg of mepolizumab) and administer SC injection into the upper arm, thigh, or abdomen. In line with clinical practice, monitoring of patients after administration of biologic agents is recommended.
- Each vial of NUCALA contains 100 mg/mL of reconstituted solution. Any residual should be discarded. Each vial should be used for a single patient.
