IN-OFFICE, ONCE-MONTHLY* DOSING & administration

NUCALA lyophilized powder

Consider in-office treatment with NUCALA lyophilized powder. Once-monthly* NUCALA is a fixed-dose (independent of weight) SC injection with no loading dose. The dose is 300 mg for EGPA patients. Administer 1 mL of the reconstituted solution for each 100-mg injection; use 3 vials for a 300-mg dose.

*Every four weeks.
SC=subcutaneous.

For NUCALA lyophilized powder

DOSING, RECONSTITUTION, ADMINistration

NUCALA lyophilized powder should be reconstituted and administered by a healthcare professional.

Recommended NUCALA dose for EGPA is 300 mg (independent of weight)
Reconstitute NUCALA in the vial
- Instructions for manual and mechanical reconstitution are in videos and text below
- Reconstituted solution will contain 100 mg/mL of NUCALA

Do not mix with other medications
Administer 1 mL of the reconstituted solution for each 100-mg injection
3 SC 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

transcript

TEXT ONSCREEN:

Reconstitution Instructions for NUCALA^® (mepolizumab)

This is an instructional video for the manual 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 manual 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.

For the manual 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:

Gently swirl the vial for 10 seconds with a circular motion at 15-second intervals until the powder is dissolved.

TEXT ONSCREEN:

Gently swirl the vial for 10 seconds with a circular motion at 15-second intervals until the powder is dissolved.

ANNOUNCER:

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

TEXT ONSCREEN:

Gently swirl the vial for 10 seconds with a circular motion at 15-second intervals until the powder is dissolved.

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

ANNOUNCER:

After swirling the solution for 10 seconds, let it rest for 5 seconds and, if the powder is not completely dissolved, swirl the solution again in a circular motion for 10 seconds. Let the solution rest for another 5 seconds, and repeat the 15-second process until the powder has dissolved.

Manual reconstitution of NUCALA is typically complete within 5 minutes after the Sterile Water for Injection has been added. It can, however, take additional time.

TEXT ONSCREEN:

Reconstitution is typically complete within 5 minutes after the Sterile Water for Injection has been added, but it may take additional time.

ANNOUNCER:

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:

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:

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.

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 the solution if it 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. 818564R0 April 2017

MANUAL reconstitution of NUCALA

Reconstitution instructions for NUCALA | 4:05

Watch the detailed process for the manual reconstitution of 1 vial of NUCALA (mepolizumab).

Read dosing details in full Prescribing Information, Sect. 2

See reconstitution steps below

test

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. 818564R0 April 2017

MECHANICAL reconstitution of NUCALA

Reconstitution instructions of NUCALA | 3:52

Watch the detailed process for the mechanical reconstitution of 1 vial of NUCALA (mepolizumab).

Read dosing details in full Prescribing Information, Sect. 2

See reconstitution steps below

NUCALA reconstitution steps

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)

2nd STEP
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.

1st STEP
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

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

Read dosing details in full Prescribing Information, Sect. 2

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