How to use the NUCALA 40 mg/0.4 mL prefilled syringe (for ages 6-11)

For pediatric patients ages 6-11 only. The NUCALA 40 mg/0.4 mL prefilled syringe must be administered by an HCP (in the office) or by a caregiver (at home).

The patient caregiver may administer NUCALA injection 40 mg/0.4 mL subcutaneously after the healthcare provider determines it is appropriate.

  • transcript

    TEXT ONSCREEN:
    NUCALA (mepolizumab) Injection 40 mg/0.4 mL
    How to Use the Prefilled Syringe
    Please see the full Instructions for Use at nucala.com/howtouse

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

    TEXT ONSCREEN:
    Important information

    ANNOUNCER:
    Important information.

    TEXT ONSCREEN:
    Important information
    Prefilled syringe
    This how-to-use video offers you help and guidance for administering NUCALA with a single-use prefilled syringe.

    ANNOUNCER:
    This how-to-use video offers you help and guidance for administering NUCALA with a single-use prefilled syringe.

    TEXT ONSCREEN:
    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).

    ANNOUNCER:
    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).

    TEXT ONSCREEN:
    Know the prefilled syringe

    ANNOUNCER:
    Know the prefilled syringe.

    TEXT ONSCREEN:
    Know the prefilled syringe
    Before use
    [labels naming NUCALA prefilled syringe parts]
    Gray needle cap (needle inside)
    Automatic needle guard
    Inspection window (medicine inside)
    Stopper
    White finger grip
    White plunger

    ANNOUNCER:
    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.

    TEXT ONSCREEN:
    Know the prefilled syringe
    After use

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

    TEXT ONSCREEN:
    After use, the automatic needle guard is activated and pulls up (retracts) the needle.

    TEXT ONSCREEN:
    Know the prefilled syringe
    Supplies in carton
    • 1 Prefilled syringe
    Supplies not in carton
    • Alcohol swab
    • Cotton ball or gauze
    • Adhesive bandage
    • Sharps disposal container

    ANNOUNCER:
    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.

    TEXT ONSCREEN:
    Prepare

    ANNOUNCER:
    Prepare.

    TEXT ONSCREEN:
    Prepare
    Take out the prefilled syringe
    Take the carton out of the refrigerator and make sure the security seals are not broken.

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

    TEXT ONSCREEN:
    Prepare
    Take out the prefilled syringe
    Do not use the prefilled syringe if a security seal on the carton is broken.

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

    TEXT ONSCREEN:
    Prepare
    Take out the prefilled syringe
    Remove the tray from the carton.

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

    TEXT ONSCREEN:
    Prepare
    Take out the prefilled syringe
    Peel off the clear plastic cover from the corner of the tray.

    ANNOUNCER:
    And peel off the clear plastic cover.

    TEXT ONSCREEN:
    Prepare
    Take out the prefilled syringe
    Holding the middle of the prefilled syringe (near the inspection window), carefully take the prefilled
    syringe out of the tray.

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

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

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

    TEXT ONSCREEN:
    Prepare
    Take out the prefilled syringe
    Do not remove the gray needle cap at this step.

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

    TEXT ONSCREEN:
    Prepare
    Inspect and wait 30 minutes before use
    Check that the expiration date on the label of the prefilled syringe has not passed.

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

    TEXT ONSCREEN:
    Prepare
    Inspect and wait 30 minutes before use
    Do not use if expiration date has passed.

    ANNOUNCER:
    Do not use if expiration has passed.

    TEXT ONSCREEN:
    Prepare
    Inspect and wait 30 minutes before use
    Look at the medicine in the inspection window. It should be clear to pale yellow to pale brown in color
    and without cloudiness or particles.

    ANNOUNCER:
    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.

    TEXT ONSCREEN:
    Prepare
    Inspect and wait 30 minutes before use
    It is normal to see one or more air bubbles.

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

    TEXT ONSCREEN:
    Prepare
    Inspect and wait 30 minutes before use
    Do not use if the medicine is cloudy or discolored, or has particles.

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

    TEXT ONSCREEN:
    Prepare
    Inspect and wait 30 minutes before use
    If the medicine looks cloudy, discolored, or has particles, contact GSK for more information
    1-888-825-5249

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

    TEXT ONSCREEN:
    Prepare
    Inspect and wait 30 minutes before use
    Wait 30 minutes before use.

    ANNOUNCER:
    Wait 30 minutes.

    TEXT ONSCREEN:
    Prepare
    Inspect and wait 30 minutes before use
    Do not warm the prefilled syringe in a microwave, hot water, or direct sunlight.

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

    TEXT ONSCREEN:
    Prepare
    Inspect and wait 30 minutes before use
    Do not use the prefilled syringe if it has been left out of the carton for more than 8 hours.

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

    TEXT ONSCREEN:
    Prepare
    Choose the injection site
    You can inject in the thighs or abdomen.

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

    TEXT ONSCREEN:
    Prepare
    Choose the injection site
    Do not inject where the skin is bruised, tender, red, or hard.

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

    TEXT ONSCREEN:
    Prepare
    Choose the injection site
    Do not inject within 2 inches of the belly button.

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

    TEXT ONSCREEN:
    Prepare
    Clean the injection site
    Wash your hands with soap and water.

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

    TEXT ONSCREEN:
    Prepare
    Clean the injection site
    Clean the injection site by wiping the skin with an alcohol swab and allowing the skin to air dry.

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

    TEXT ONSCREEN:
    Prepare
    Clean the injection site
    Do not touch the cleaned injection site again until you have finished the injection.

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

    TEXT ONSCREEN:
    Inject

    ANNOUNCER:
    Inject.

    TEXT ONSCREEN:
    Inject
    Remove the gray needle cap
    Remove the gray needle cap from the prefilled syringe by pulling it straight off, away from the needle (as
    shown). It may take some force to remove the gray needle cap.

    ANNOUNCER:
    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.

    TEXT ONSCREEN:
    Inject
    Remove the gray needle cap
    You may see a drop of medicine at the end of the needle. This is normal.

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

    TEXT ONSCREEN:
    Inject
    Remove the gray needle cap
    Make sure you inject within 5 minutes after you remove the gray needle cap.

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

    TEXT ONSCREEN:
    Inject
    Remove the gray needle cap
    Do not let the needle touch any surface.

    ANNOUNCER:
    Do not let the needle touch any surface.

    TEXT ONSCREEN:
    Inject
    Remove the gray needle cap
    Do not let touch the needle.

    ANNOUNCER:
    Do not touch the needle.

    TEXT ONSCREEN:
    Inject
    Remove the gray needle cap
    Do not touch the white plunger at this step. This could
    accidentally push medicine out, and the full dose will not be given.

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

    TEXT ONSCREEN:
    Inject
    Remove the gray needle cap
    Do not try to remove any air bubbles from the prefilled syringe.

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

    TEXT ONSCREEN:
    Inject
    Remove the gray needle cap
    Do not put the gray needle cap back on the syringe. This could cause a needle injury.

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

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

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

    TEXT ONSCREEN:
    Inject
    Start the injection
    Insert the entire needle into the pinched skin at a 45░ angle, as shown.

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

    TEXT ONSCREEN:
    Inject
    Start the injection
    Move your thumb to the white plunger and use your other fingers to hold onto the white finger grip.

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

    TEXT ONSCREEN:
    Inject
    Start the injection
    Slowly push down on the white plunger to inject the full dose.

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

    TEXT ONSCREEN:
    Inject
    Complete the injection
    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.

    ANNOUNCER:
    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.

    TEXT ONSCREEN:
    Inject
    Complete the injection
    Slowly lift your thumb up. This will allow the white plunger to come up and the needle to automatically
    retract (pull up) into the body of the syringe.

    ANNOUNCER:
    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.

    TEXT ONSCREEN:
    Inject
    Complete the injection
    After the injection is complete, release the pinched skin.

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

    TEXT ONSCREEN:
    Inject
    Complete the injection
    There may be a small drop of blood at the injection site. This is normal. Press a cotton ball or gauze on
    the area and apply an adhesive bandage if you need it.

    ANNOUNCER:
    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.

    TEXT ONSCREEN:
    Inject
    Complete the injection
    Do not rub the injection site.

    ANNOUNCER:
    Do not rub the injection site.

    TEXT ONSCREEN:
    Inject
    Complete the injection
    Do not put the gray needle cap back onto the syringe.

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

    TEXT ONSCREEN:
    Dispose

    ANNOUNCER:
    Dispose.

    TEXT ONSCREEN:
    Dispose
    Throw away the used syringe
    Put the used syringe and gray needle cap in an FDA-cleared sharps disposal container right away after
    use.

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

    TEXT ONSCREEN:
    Dispose
    Throw away the used syringe
    If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
    • made of heavy-duty plastic;
    • able to close with a tight-fitting, puncture-resistant lid, without sharps being able to come out;
    • upright and stable during use;
    • leak-resistant;
    • properly labeled to warn of hazardous waste inside the container.

    ANNOUNCER:
    If you dont 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.

    TEXT ONSCREEN:
    Dispose
    Throw away the used syringe
    When your sharps disposal container is almost full, you will need to follow your community guidelines
    for the right way to dispose of it. There may be state or local laws about how you should throw away
    used syringes.
    Do not throw away your used sharps disposal container in your household trash unless your
    community guidelines permit this.
    Do not recycle your used sharps disposal container.
    Keep your sharps disposal container out of the reach of children.
    For more information about safe sharps disposal, visit www.fda.gov/safesharpsdisposal.

    ANNOUNCER:
    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.

    TEXT ONSCREEN:
    For More Information

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

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

    TEXT ONSCREEN:
    Trademarks are owned by or licensed to the GSK group of companies.©2022 GSK or licensor.
    MPLVID220002 April 2022. Produced in USA.

Intended for use under HCP guidance. Provide proper training on injection technique and administration using the full Instructions for Use after determining at-home use is appropriate.

STORAGE INFORMATION

  • Store in the refrigerator between 36˚F and 46˚F (2˚C and 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.
  • Safely throw away the prefilled syringe if it is left out of the refrigerator for more than 7 days.
  • The prefilled syringe must be used within 8 hours after you take it out of the carton. Safely throw it away if it is not used within 8 hours.
  • Safely throw away medicine that is out of date or no longer needed.

Keep NUCALA and all medicines out of the reach of children.

WARNINGS

Do not use the prefilled syringe more than 1 time. Throw away the prefilled syringe in an FDA-cleared sharps disposal container after your injection.
Do not share the prefilled syringe with other people. You may give other people a serious infection, or you may get a serious infection from them.
Do not use the prefilled syringe if it was dropped or looks damaged.