NUCALA in-office dosing and administration for HES

Lyophilized powder for in-office reconstitution and administration

Consider in-office dosing and administration or choose at-home administration for appropriate patients.

View at-home administration

Lyophilized powder vials image

Administer 1 mL of the reconstituted
solution for each 100-mg injection; use
3 vials for a 300-mg dose.

The only HES treatment to offer:

  • Once-monthly dosing (every 4 weeks)
  • No loading dose
  • Fixed dose (independent of weight)
  • NUCALA lyophilized powder should be administered by a healthcare professional
  • 3 once-monthly subcutaneous injections (every 4 weeks) into the upper arm, thigh, or abdomen at least 2 inches (5 cm) apart
  • In line with clinical practice, monitoring of patients after administration of biologic agents is recommended

The recommended dose for HES is 300 mg. Administer 1 mL of the reconstituted solution for each 100-mg injection.

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:

  • 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)
Step one reconstituting NUCALA image

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 image

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.

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.

  • View transcript

    TEXT ONSCREEN:

    Reconstitution Instructions for NUCALA® (mepolizumab)

    This is an instructional video for the mechanical reconstitution of NUCALA® (mepolizumab).

    NUCALA should be reconstituted and administered by a healthcare professional.

    For additional information, please see full Prescribing Information at www.NUCALAprep.com

    ANNOUNCER:

    This is an instructional video for the mechanical reconstitution of NUCALA (mepolizumab).

    NUCALA should be reconstituted and administered by a healthcare professional.

    For additional information, please see the full Prescribing Information at www.NUCALAprep.com.

    For the mechanical reconstitution of NUCALA, you will need the following items:

    ·     alcohol swabs

    ·     a vial of Sterile Water for Injection, USP

    ·     a 2- or 3-milliliter syringe and a 21-gauge needle

    ·     and a 100 milligram vial of NUCALA (mepolizumab)

    TEXT ONSCREEN:

    [labels for items]

    Sterile Water for Injection, USP

    NUCALA® (mepolizumab) 100 mg for subcutaneous use

    2 or 3 mL syringe and a 21-gauge needle are preferred.

    *Syringes, alcohol swabs and Sterile Water for Injection are not provided.

    DO NOT MIX WITH OTHER MEDICATIONS.

    ANNOUNCER:

    Set the vial labeled NUCALA aside and uncap the vial of Sterile Water for Injection. Next, uncap the vial of NUCALA. Remove an alcohol swab from its packet and swab the top of the vial of NUCALA. Do the same for the vial of Sterile Water for Injection. For reconstitution, it is preferred that you use a 2- or 3-milliliter syringe and a 21-gauge needle. Insert the syringe into the vial of Sterile Water for Injection and withdraw 1.2 milliliters of Sterile Water for Injection.

    TEXT ONSCREEN:

    Withdraw 1.2 mL Sterile Water for Injection.

    ANNOUNCER:

    Remove excess air from syringe. Verify the amount of Sterile Water for Injection in the syringe before inserting it into the vial of NUCALA.

    TEXT ONSCREEN:

    1.2 mL Sterile Water for Injection

    ANNOUNCER:

    Insert the needle into the vial of NUCALA.

    TEXT ONSCREEN:

    NUCALA 100 mg for subcutaneous use

    ANNOUNCER:

    Direct the stream of Sterile Water for Injection vertically onto the center of the lyophilized cake.

    TEXT ONSCREEN:

    Direct the stream of Sterile Water for Injection vertically onto the center of the lyophilized cake.

    ANNOUNCER:

    Remove the syringe and place the vial of NUCALA in a mechanical reconstitution device or swirler.

    TEXT ONSCREEN:

    Do not shake the reconstituted solution during the procedure as this may lead to product foaming or precipitation.

    ANNOUNCER:

    Do not shake the reconstituted solution during the procedure as this may lead to product foaming or precipitation.

    TEXT ONSCREEN:

    450 RPM for no longer than 10 minutes

    ANNOUNCER:

    Set the swirler to 450 RPM and swirl the solution for no longer than 10 minutes.

    TEXT ONSCREEN:

    450 RPM for no longer than 10 minutes

    1000 RPM for no longer than 5 minutes

    ANNOUNCER:

    As an alternative, you can increase the speed to 1000 RPM and swirl the solution for no longer than 5 minutes.

    Be sure to visually inspect the reconstituted solution for particulate matter and clarity before use. The solution should be clear to opalescent, colorless to pale yellow or pale brown, and essentially particulate-free.

    TEXT ONSCREEN:

    Visually inspect the reconstituted solution for particulate matter and clarity before use.

    The solution should be clear to opalescent and colorless to pale yellow or pale brown, essentially particle-free.

    ANNOUNCER:

    Small air bubbles in the solution are to be expected and acceptable.

    If particulate matter remains in the solution or if the solution appears cloudy or milky, the solution must not be administered.

    TEXT ONSCREEN:

    Visually inspect the reconstituted solution for particulate matter and clarity before use.

    The solution should be clear to opalescent and colorless to pale yellow or pale brown, essentially particle-free.

    Small air bubbles in the solution are to be expected and acceptable.

    If particulate matter remains in the solution or if the solution appears cloudy or milky, the solution must not be administered.

    ANNOUNCER:

    The reconstituted solution will contain a concentration of 100 milligrams/milliliter mepolizumab.

    DO NOT mix NUCALA with other medications.

    TEXT ONSCREEN:

    The reconstituted solution will contain a concentration of 100 mg/mL of NUCALA® (mepolizumab).

    DO NOT MIX WITH OTHER MEDICATIONS.

    ANNOUNCER:

    Once reconstituted, NUCALA can be administered right away.

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

    If not used immediately after preparation, store the reconstituted solution of NUCALA at a temperature below 30° Celsius (86° Fahrenheit), but DO NOT freeze.

    Discard if the solution has not been used within 8 hours of reconstitution.

    For additional information, please see the full Prescribing Information for NUCALA.

    TEXT ONSCREEN:

    Reconstitution Instructions for NUCALA® (mepolizumab)

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

    If not used immediately after preparation, store the reconstituted solution of NUCALA at a temperature below 30°C (86°F), but DO NOT freeze.

    Discard the solution if it has not been used within 8 hours of reconstitution.

    For additional information, please see full Prescribing Information for NUCALA.

    ©2017 GSK group of companies. All rights reserved. 818564RO April 2017

    Close transcript

Mechanical reconstitution instructions

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

  • View transcript

    TEXT ONSCREEN:

    Reconstitution Instructions for NUCALA® (mepolizumab)

    This is an instructional video for the mechanical reconstitution of NUCALA® (mepolizumab).

    NUCALA should be reconstituted and administered by a healthcare professional.

    For additional information, please see full Prescribing Information at www.NUCALAprep.com

    ANNOUNCER:

    This is an instructional video for the mechanical reconstitution of NUCALA (mepolizumab).

    NUCALA should be reconstituted and administered by a healthcare professional.

    For additional information, please see the full Prescribing Information at www.NUCALAprep.com.

    For the mechanical reconstitution of NUCALA, you will need the following items:

    ·     alcohol swabs

    ·     a vial of Sterile Water for Injection, USP

    ·     a 2- or 3-milliliter syringe and a 21-gauge needle

    ·     and a 100 milligram vial of NUCALA (mepolizumab)

    TEXT ONSCREEN:

    [labels for items]

    Sterile Water for Injection, USP

    NUCALA® (mepolizumab) 100 mg for subcutaneous use

    2 or 3 mL syringe and a 21-gauge needle are preferred.

    *Syringes, alcohol swabs and Sterile Water for Injection are not provided.

    DO NOT MIX WITH OTHER MEDICATIONS.

    ANNOUNCER:

    Set the vial labeled NUCALA aside and uncap the vial of Sterile Water for Injection. Next, uncap the vial of NUCALA. Remove an alcohol swab from its packet and swab the top of the vial of NUCALA. Do the same for the vial of Sterile Water for Injection. For reconstitution, it is preferred that you use a 2- or 3-milliliter syringe and a 21-gauge needle. Insert the syringe into the vial of Sterile Water for Injection and withdraw 1.2 milliliters of Sterile Water for Injection.

    TEXT ONSCREEN:

    Withdraw 1.2 mL Sterile Water for Injection.

    ANNOUNCER:

    Remove excess air from syringe. Verify the amount of Sterile Water for Injection in the syringe before inserting it into the vial of NUCALA.

    TEXT ONSCREEN:

    1.2 mL Sterile Water for Injection

    ANNOUNCER:

    Insert the needle into the vial of NUCALA.

    TEXT ONSCREEN:

    NUCALA 100 mg for subcutaneous use

    ANNOUNCER:

    Direct the stream of Sterile Water for Injection vertically onto the center of the lyophilized cake.

    TEXT ONSCREEN:

    Direct the stream of Sterile Water for Injection vertically onto the center of the lyophilized cake.

    ANNOUNCER:

    Remove the syringe and place the vial of NUCALA in a mechanical reconstitution device or swirler.

    TEXT ONSCREEN:

    Do not shake the reconstituted solution during the procedure as this may lead to product foaming or precipitation.

    ANNOUNCER:

    Do not shake the reconstituted solution during the procedure as this may lead to product foaming or precipitation.

    TEXT ONSCREEN:

    450 RPM for no longer than 10 minutes

    ANNOUNCER:

    Set the swirler to 450 RPM and swirl the solution for no longer than 10 minutes.

    TEXT ONSCREEN:

    450 RPM for no longer than 10 minutes

    1000 RPM for no longer than 5 minutes

    ANNOUNCER:

    As an alternative, you can increase the speed to 1000 RPM and swirl the solution for no longer than 5 minutes.

    Be sure to visually inspect the reconstituted solution for particulate matter and clarity before use. The solution should be clear to opalescent, colorless to pale yellow or pale brown, and essentially particulate-free.

    TEXT ONSCREEN:

    Visually inspect the reconstituted solution for particulate matter and clarity before use.

    The solution should be clear to opalescent and colorless to pale yellow or pale brown, essentially particle-free.

    ANNOUNCER:

    Small air bubbles in the solution are to be expected and acceptable.

    If particulate matter remains in the solution or if the solution appears cloudy or milky, the solution must not be administered.

    TEXT ONSCREEN:

    Visually inspect the reconstituted solution for particulate matter and clarity before use.

    The solution should be clear to opalescent and colorless to pale yellow or pale brown, essentially particle-free.

    Small air bubbles in the solution are to be expected and acceptable.

    If particulate matter remains in the solution or if the solution appears cloudy or milky, the solution must not be administered.

    ANNOUNCER:

    The reconstituted solution will contain a concentration of 100 milligrams/milliliter mepolizumab.

    DO NOT mix NUCALA with other medications.

    TEXT ONSCREEN:

    The reconstituted solution will contain a concentration of 100 mg/mL of NUCALA® (mepolizumab).

    DO NOT MIX WITH OTHER MEDICATIONS.

    ANNOUNCER:

    Once reconstituted, NUCALA can be administered right away.

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

    If not used immediately after preparation, store the reconstituted solution of NUCALA at a temperature below 30° Celsius (86° Fahrenheit), but DO NOT freeze.

    Discard if the solution has not been used within 8 hours of reconstitution.

    For additional information, please see the full Prescribing Information for NUCALA.

    TEXT ONSCREEN:

    Reconstitution Instructions for NUCALA® (mepolizumab)

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

    If not used immediately after preparation, store the reconstituted solution of NUCALA at a temperature below 30°C (86°F), but DO NOT freeze.

    Discard the solution if it has not been used within 8 hours of reconstitution.

    For additional information, please see full Prescribing Information for NUCALA.

    ©2017 GSK group of companies. All rights reserved. 818564RO April 2017

    REPEAT process for remaining 2 vials

    Close transcript