In-office, once-monthly dosing and administration

Lyophilized powder for in-office reconstitution and administration

NUCALA offers:

  • Once-monthly dosing (every 4 weeks)
  • No loading dose
  • Fixed-dose (independent of weight)

Patients aged ≥12 years

  • 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

Reconstituting NUCALA

 

NUCALA should be reconstituted by a healthcare professional. The reconstituted solution will contain a concentration of 100 mg/mL mepolizumab. Do not mix with other medications.
 

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)
Step one reconstituting NUCALA

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.

 

 

Step two reconstituting NUCALA

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.

Storage

If the reconstituted solution is not used immediately:

  • Store below 30°C (86°F)
    • Does not require refrigeration if stored below 30°C (86°F)
  • Do not freeze
  • Discard if not used within 8 hours of reconstitution

Manual and mechanical reconstitution instructions for NUCALA


Manual reconstitution instructions

This video includes instructions for the manual reconstitution of one vial of NUCALA. See also Section 2 of the Prescribing Information.


Mechanical reconstitution instructions

This video includes instructions for the mechanical reconstitution of one vial of NUCALA. See also Section 2 of the Prescribing Information.

 

In-office dosing and administration for ages 6–11

 

Learn about at-home 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.