PEDIATRIC DOSING & ADMINISTRATION (AGES 6-11)

Pediatric patients ages 6-11 can receive NUCALA at home or in the office. The 40 mg/0.4 mL prefilled syringe can be used in either location and must be administered by a healthcare professional or patient caregiver. The patient caregiver may administer NUCALA after the healthcare provider determines it is appropriate. Children with SEA can also receive NUCALA lyophilized powder, which is reconstituted and administered in-office by a healthcare professional.

Once-monthly* NUCALA is a fixed-dose (independent of weight) SC injection with no loading dose. For ages 6-11, the recommended dose is 40 mg SC once monthly.*


(To see options for ages 12+, go to at-home dosing & admin or in-office dosing & admin.)

*Every four weeks.
SC=subcutaneous.

At-home or in-office dosing (ages 6-11) and administration with NUCALA 40 mg/0.4 mL prefilled syringe

Watch this instructional video, and read details below, including Warnings and Storage Info.

40 mg Prefilled Syringe for Patients Aged 6-11 Years

  • transcript

    VOICEOVER:
    This is the How to Use video for the NUCALA (mepolizumab)
    single-use prefilled syringe for appropriate patients.

    VOICEOVER:
    Important information.

    VOICEOVER:
    This how-to-use video offers you help and guidance for administering NUCALA with a single-use prefilled syringe.
    Please read the full Instructions for Use contained in the NUCALA carton. Carefully follow this information so that you complete each step successfully. The healthcare provider should show you how to use the prefilled syringe before the first injection. The NUCALA prefilled syringe is only for use under the skin (subcutaneous).

    VOICEOVER:
    Know the prefilled syringe.

    VOICEOVER:
    Please take note of the NUCALA prefilled syringe parts so that you are familiar with them throughout this video and while you are giving the injection. Please examine the prefilled syringe before injecting.

    VOICEOVER:
    After use, the automatic needle guard is activated and pulls up the needle.

    VOICEOVER:
    To perform the injection, you will need the NUCALA prefilled syringe. You will also need an alcohol swab, a gauze pad or cotton ball, an adhesive bandage, and a sharps disposal container. These materials are not included with NUCALA, so make sure you have them on hand before you inject.

    VOICEOVER:
    Prepare.

    VOICEOVER:
    Take out prefilled syringe.
    Take the carton out of the refrigerator, check to make sure the security seals aren’t broken.

    VOICEOVER:
    If a seal is broken, do not use the prefilled syringe.

    VOICEOVER:
    Now, take the tray out of the carton.

    VOICEOVER:
    And peel off the clear plastic cover.

    VOICEOVER:
    Holding the middle of the prefilled syringe, carefully take the prefilled syringe out of the tray.

    VOICEOVER:
    Place the prefilled syringe down on a clean, flat surface, at room temperature away from direct sunlight and out of the reach of children.

    VOICEOVER:
    Do not remove the gray needle cap at this step.

    VOICEOVER:
    Inspect and wait 30 minutes.
    Check the expiration date on the prefilled syringe.

    VOICEOVER:
    Do not use if expiration has passed.

    VOICEOVER:
    Look in the inspection window to check that the NUCALA medicine is clear to pale yellow to pale brown in color and without cloudiness or particles.

    VOICEOVER:
    It is normal to see one or more air bubbles in the solution.

    VOICEOVER:
    Do not use if it looks cloudy, discolored, or has particles.

    VOICEOVER:
    If the medicine looks cloudy, discolored, or has particles contact GSK
    for more information at 1-888-825-5249.

    VOICEOVER:
    Wait 30 minutes.

    VOICEOVER:
    Do not warm the prefilled syringe in any other way. For example,
    do not warm in a microwave oven, hot water, or direct sunlight.

    VOICEOVER:
    Do not use the prefilled syringe if it has been left out of the carton
    for more than 8 hours.

    VOICEOVER:
    Prepare and choose the injection site.
    Choose where to inject in the thighs, abdomen, or upper arm, in the
    highlighted areas shown here.

    VOICEOVER:
    Do not inject where the skin is bruised, tender, red or hard.

    VOICEOVER:
    Do not inject within 2 inches of the belly button.

    VOICEOVER:
    Prepare and clean the injection site.
    Wash your hands with soap and water.

    VOICEOVER:
    Next clean the injection site by wiping it with an alcohol swab.
    Allow the skin to air dry.

    VOICEOVER:
    Do not touch this area again before giving the injection.

    VOICEOVER:
    Inject.

    VOICEOVER:
    Remove the gray needle cap.
    Now, remove the gray needle cap by pulling it straight off, away
    from the needle - this could take a little force.

    VOICEOVER:
    It’s normal to see a drop of medicine at the end of the needle.

    VOICEOVER:
    Make sure you inject within 5 minutes after removing the gray needle
    cap.

    VOICEOVER:
    Do not let the needle touch any surface.

    VOICEOVER:
    Do not touch the needle.

    VOICEOVER:
    Do not touch the white plunger at this step. This could accidentally
    push medicine out, and the full dose will not be given.

    VOICEOVER:
    Do not try to remove any air bubbles from the prefilled syringe.

    VOICEOVER:
    Do not put the gray needle cap back on the prefilled syringe.
    This could cause a needle injury.

    VOICEOVER:
    Inject.
    Start injection.
    Use your free hand to pinch the skin around the injection site.
    Keep pinching throughout the injection.

    VOICEOVER:
    Insert the entire needle into the pinched skin at a 45° angle, as
    shown.

    VOICEOVER:
    Move your thumb to the white plunger and use your other fingers
    to hold onto the white finger grip.

    VOICEOVER:
    Slowly push down on the white plunger to inject the full dose.

    VOICEOVER:
    Make sure the white plunger is pushed all the way down until the
    stopper reaches the bottom of the syringe and all of the medicine is
    injected.

    VOICEOVER:
    Slowly lift your thumb up. This will allow the white plunger to come
    up and the needle to automatically pull up into the body of the
    syringe.

    VOICEOVER:
    After the injection is complete, release the pinched skin.

    VOICEOVER:
    You may see a small drop of blood, which is normal. Gently press a
    cotton ball or gauze on the area and apply an adhesive bandage if
    you need it.

    VOICEOVER:
    Do not rub the injection site.

    VOICEOVER:
    Do not put the gray needle cap back onto the syringe.

    VOICEOVER:
    Dispose.

    VOICEOVER:
    To clean up, put the used syringe and gray needle cap in a sharps
    disposal container right away.

    VOICEOVER:
    If you don’t have an FDA-cleared sharps disposal container, you can
    use any household container that is made of heavy-duty plastic, is
    able to close with a tight-fitting, puncture-resistant lid, is upright and
    stable, leak resistant, and properly labeled to warn that hazardous
    waste is inside.

    VOICEOVER:
    Do not throw the sharps container in household trash unless your
    community guidelines permit this. Do not recycle your used sharps
    container. Always keep the sharps container out of the reach of
    children.

    VOICEOVER:
    If you have any questions or need more information, talk to
    the prescribing doctor.
    For additional resources and support visit NUCALA.com

How to use the prefilled syringe

How to use the prefilled syringe | 7:34

This NUCALA 40 mg/0.4 mL single-use prefilled syringe, for ages 6-11, can be administered at home by a caretaker or in the office by a healthcare professional.

40 mg/0.4 mL prefilled syringe full Instructions for Use

See Warnings & Storage info below

For NUCALA 40 mg/0.4 mL prefilled syringe

DOSING & ADMINISTRATION

  • Recommended NUCALA dose for ages 6-11 is 40 mg (independent of weight)
  • Intended for use with guidance by a healthcare professional
  • SC injection every 4 weeks by healthcare professional or caregiver into the thigh, abdomen, or upper arm
  • Each single-use prefilled syringe is for 1 patient only 
  • In line with clinical practice, monitoring of patients after administration of biologic agents is recommended

Keep NUCALA and all medicines away from children.

WARNINGS

  • Do not use any prefilled syringe more than 1 time
  • Do not share the prefilled syringe with other people
  • Do not use the prefilled syringe if it was dropped or looks damaged

STORAGE INFO

  • Store in the refrigerator between 36°F to 46°F (2°C to 8°C)
  • Keep in the original carton until time of use to protect from light
  • Do not freeze
  • Do not shake
  • Keep away from heat
  • If necessary, an unopened carton can be stored outside the refrigerator at up to 86°F (30°C) for up to 7 days
  • Do not use the prefilled syringe if it has been left out of the carton for more than 8 hours

In-office dosing (ages 6-11), reconstitution, and administration of NUCALA lyophilized powder

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

(For the other pediatric [ages 6-11] administration option, 40 mg/0.4 mL prefilled syringe, see info above.)

  • Recommended NUCALA dose for ages 6-11 is 40 mg (independent of weight)
  • Reconstitute* NUCALA in the vial 
  • Remove and administer 0.4 mL of the reconstituted solution (equivalent to 40 mg of mepolizumab)   
  • Because each NUCALA vial should only be used for 1 patient, discard the remaining solution
  • SC injection every 4 weeks into the thigh, abdomen, or upper arm
  • In line with clinical practice, monitoring of patients after administration of biologic agents is recommended
  • 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

*See reconstitution instructions on the In-office dosing & administration page.

Lyophilized powder bottle
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