At-home, once-monthly* dosing and administration

The NUCALA Autoinjector for at-home administration.

Easy to use

At-home convenience

  • Study Description

    12-week, open-label study assessed the correct use of the NUCALA Autoinjector in patients aged ≥12 years with severe eosinophilic asthma (n=104). NUCALA was administered as one 100-mg subcutaneous injection every 4 weeks by the patient or caregiver after being trained on proper technique with the Autoinjector at baseline. Successful use was determined by investigator observation using a checklist of steps based on Instructions for Use and visually inspecting the Autoinjector following the third dose. Ease of use and convenience of use at home were measured at study end on a 5-point scale (not at all, a little, moderately, very, and extremely) in the 102 patients with successful use.1,2

NUCALA offers:

  • Once-monthly dosing (every 4 weeks)
  • No loading dose
  • Fixed-dose (independent of weight)

At-home dosing and administration with the NUCALA Autoinjector or prefilled syringe

  • Fixed 100-mg dose for patients aged 12 and older independent of weight
  • NUCALA may be administered by the patient or a caregiver
  • Subcutaneous injection every 4 weeks into the thigh or abdomen (or upper arm by caregiver)
  • Intended for use under HCP guidance. Provide proper training on injection technique and administration using the Instructions for Use after determining at home use is appropriate.

Administration of NUCALA with a single-use Autoinjector


How to use the Autoinjector

Autoinjector: A patient perspective

Administration of NUCALA with a single-use prefilled syringe

At-home, once-monthly 40 mg/0.4 mL prefilled syringe for ages 6-11

The 40 mg/0.4 mL prefilled syringe is only for use in children aged 6 to 11 years and must be administered by the healthcare provider or the patient caregiver.

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

40 mg Prefilled Syringe for Pediatric Patients


How to use the 40 mg/0.4 mL prefilled syringe

  • View transcript

    ONSCREEN TEXT:

    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

    NARRATOR:

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

    NARRATOR and ONSCREEN TEXT:

    Important information

    ONSCREEN TEXT:

    Important information

    Prefilled syringe

    NARRATOR and ONSCREEN TEXT:

    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).

    NARRATOR and ONSCREEN TEXT:

    Know the prefilled syringe

    ONSCREEN TEXT:

    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

    NARRATOR:

    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.

    ONSCREEN TEXT:

    Know the prefilled syringe

    After use

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

    NARRATOR:

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

    ONSCREEN TEXT:

    Know your prefilled syringe

    Supplies in carton

    ·         1 Prefilled syringe

    Supplies not in carton

    ·         Alcohol swab

    ·         Cotton ball or gauze

    ·         Adhesive bandage

    ·         Sharps disposal container

    NARRATOR:

    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.

    NARRATOR and ONSCREEN TEXT:

    Prepare

    ONSCREEN TEXT:

    Prepare

    Take out the prefilled syringe

    Take the carton out of the refrigerator and make sure the security seals are not broken.

    NARRATOR:

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

    ONSCREEN TEXT:

    Prepare

    Take out the prefilled syringe

    Do not use the prefilled syringe if a security seal on the carton is broken.

    NARRATOR:

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

    ONSCREEN TEXT:

    Prepare

    Take out the prefilled syringe

    Remove the tray from the carton.

    NARRATOR:

    Now, take the tray out of the carton.

    ONSCREEN TEXT:

    Prepare

    Take out the prefilled syringe

    Peel off the clear plastic cover from the corner of the tray.

    NARRATOR:

    And peel off the clear plastic cover.

    ONSCREEN TEXT:

    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.

    NARRATOR:

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

    ONSCREEN TEXT:

    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.

    NARRATOR:

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

    ONSCREEN TEXT:

    Prepare

    Take out the prefilled syringe

    NARRATOR and ONSCREEN TEXT:

    Do not remove the gray needle cap at this step.

    ONSCREEN TEXT:

    Prepare

    Inspect and wait 30 minutes before use

    Check that the expiration date on the label of the prefilled syringe has not passed.

    NARRATOR:

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

    ONSCREEN TEXT:

    Prepare

    Inspect and wait 30 minutes before use

    Do not use if expiration date has passed.

    NARRATOR:

    Do not use if expiration has passed.

    ONSCREEN TEXT:

    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.

    NARRATOR:

    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.

    ONSCREEN TEXT:

    Prepare

    Inspect and wait 30 minutes before use

    It is normal to see one or more air bubbles.

    NARRATOR:

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

    ONSCREEN TEXT:

    Prepare

    Inspect and wait 30 minutes before use

    Do not use if the medicine is cloudy or discolored, or has particles.

    NARRATOR:

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

    ONSCREEN TEXT:

    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

    NARRATOR:

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

    ONSCREEN TEXT:

    Prepare

    Inspect and wait 30 minutes before use

    Wait 30 minutes before use.

    [clock graphic] Wait 30 minutes

    NARRATOR:

    Wait 30 minutes.

    ONSCREEN TEXT:

    Prepare

    Inspect and wait 30 minutes before use

    Do not warm the prefilled syringe in a microwave, hot water, or direct sunlight.

    NARRATOR:

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

    ONSCREEN TEXT:

    Prepare

    Inspect and wait 30 minutes before use

    NARRATOR and ONSCREEN TEXT:

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

    ONSCREEN TEXT:

    Prepare

    Choose the injection site

    You can inject in the thighs, abdomen, or upper arm.

    NARRATOR:

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

    ONSCREEN TEXT:

    Prepare

    Choose the injection site

    NARRATOR and ONSCREEN TEXT:

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

    ONSCREEN TEXT:

    Prepare

    Choose the injection site

    NARRATOR and ONSCREEN TEXT:

    Do not inject within 2 inches of the belly button.

    ONSCREEN TEXT:

    Prepare

    Clean the injection site

    Wash your hands with soap and water.

    NARRATOR:

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

    ONSCREEN TEXT:

    Prepare

    Clean the injection site

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

    NARRATOR:

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

    ONSCREEN TEXT:

    Prepare

    Clean the injection site

    Do not touch the cleaned injection site again until you have finished the injection.

    NARRATOR:

    Do not touch this area again before giving the injection.

    NARRATOR and ONSCREEN TEXT:

    Inject

    ONSCREEN TEXT:

    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.

    NARRATOR:

    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.

    ONSCREEN TEXT:

    Inject

    Remove the gray needle cap

    You may see a drop of medicine at the end of the needle. This is normal.

    NARRATOR:

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

    ONSCREEN TEXT:

    Inject

    Remove the gray needle cap

    Make sure you inject within 5 minutes after you remove the gray needle cap.

    NARRATOR:

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

    ONSCREEN TEXT:

    Inject

    Remove the gray needle cap

    NARRATOR and ONSCREEN TEXT:

    Do not let the needle touch any surface.

    ONSCREEN TEXT:

    Inject

    Remove the gray needle cap

    NARRATOR and ONSCREEN TEXT:

    Do not touch the needle.

    ONSCREEN TEXT:

    Inject

    Remove the gray needle cap

    NARRATOR and ONSCREEN TEXT:

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

    ONSCREEN TEXT:

    Inject

    Remove the gray needle cap

    NARRATOR and ONSCREEN TEXT:

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

    ONSCREEN TEXT:

    Inject

    Remove the gray needle cap

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

    NARRATOR:

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

    ONSCREEN TEXT:

    Inject

    Start the injection

    Use your free hand to pinch the skin around the injection site. Keep pinching the skin throughout the injection.

    NARRATOR:

    Inject.

    Start injection.

    Use your free hand to pinch the skin around the injection site. Keep pinching throughout the injection.

    ONSCREEN TEXT:

    Inject

    Start the injection

    NARRATOR and ONSCREEN TEXT:

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

    ONSCREEN TEXT:

    Inject

    Start the injection

    NARRATOR and ONSCREEN TEXT:

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

    ONSCREEN TEXT:

    Inject

    Start the injection

    NARRATOR and ONSCREEN TEXT:

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

    ONSCREEN TEXT:

    Inject

    Complete the injection

    NARRATOR and ONSCREEN TEXT:

    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.

    ONSCREEN TEXT:

    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.

    NARRATOR:

    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.

    ONSCREEN TEXT:

    Inject

    Complete the injection

    NARRATOR and ONSCREEN TEXT:

    After the injection is complete, release the pinched skin.

    ONSCREEN TEXT:

    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.

    NARRATOR:

    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.

    ONSCREEN TEXT:

    Inject

    Complete the injection

    NARRATOR and ONSCREEN TEXT:

    Do not rub the injection site.

    ONSCREEN TEXT:

    Inject

    Complete the injection

    NARRATOR and ONSCREEN TEXT:

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

    NARRATOR and ONSCREEN TEXT:

    Dispose

    ONSCREEN TEXT:

    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.

    NARRATOR:

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

    ONSCREEN TEXT:

    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.

    NARRATOR:

    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.

    ONSCREEN TEXT:

    Dispose

    Throw away your 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.

    NARRATOR:

    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.

    ONSCREEN TEXT:

    For More Information

    ONSCREEN TEXT:

    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.

    NARRATOR:

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

    ONSCREEN TEXT:

    Trademarks are owned by or licensed to the GSK group of companies.

    ©2022 GSK or licensor.

    MPLVID220002 April 2022.

    Produced in USA.

Keep NUCALA and all medicines away from children.

WARNINGS

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

STORAGE INFORMATION

  • 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 Autoinjector or prefilled syringe if it has been left out of the carton for more than 8 hours