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DOSING & ADMINISTRATION

POWER TO CHOOSE

The only HES treatment to offer:

Once-monthly dosing

(every 4 weeks)

+

No loading dose

+

Fixed-dose

(independent of weight)

Lyophilized Powder

ADMINISTERING NUCALA FOR HES

The recommended dosage of NUCALA for HES is 300 mg administered once every 4 weeks as 3 separate 100-mg subcutaneous injections into the upper arm, thigh, or abdomen. Administer individual 100-mg injections at least 2 inches (5 cm) apart.

Ensure you have everything you need for subcutaneous administration of 3 reconstituted vials:

  • A syringe (preferably 1 mL) for each vial
  • A needle (preferably 21- to 27-gauge, 0.5 inch) for each syringe

Withdraw 1 mL from each of the 3 vials into 3 separate syringes for administration.

Administer the 3 individual injections into upper arm, thigh, or abdomen at least 2 inches (5 cm) apart.

Icon of medicine bottle

No pretreatment recommendations for NUCALA in Prescribing Information; therefore:

  • No premedication requirement
  • No requirement for complete blood or platelet counts
  • No screening required for hepatitis B, hepatitis C, or tuberculosis
Icon of checklist

In line with clinical practice, monitoring of patients after administration of biologic agents is recommended

  • Prescribing Information for NUCALA does not include post-treatment recommendations for regular monitoring of blood counts
  • If patient develops helminth infection and does not respond to anti-helminth treatment, discontinue NUCALA until infection resolves

Reconstituting NUCALA for HES

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

Ensure you have everything you need to reconstitute NUCALA for HES:

  • 3 vials of NUCALA
  • For each vial, 1.2 mL Sterile Water 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 powder, which may have a cake-like appearance.

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.

Repeat process for the remaining 2 vials.

Manual reconstitution is typically complete ≈5 minutes after the Sterile 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.

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

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.