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NUCALA is indicated for the add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe eosinophilic asthma (SEA). NUCALA is not for relief of acute bronchospasm or status asthmaticus.
The NUCALA Autoinjector is only for use in patients aged ≥12 years.
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
The only nasal polyps biologic to offer:
Once-monthly dosing(every 4 weeks)
No loading dose
Fixed-dose(independent of weight)
At-home dosing and administration with the NUCALA Autoinjector:
Fixed 100-mg dose 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 full Instructions for Use after determining at-home use is appropriate.
Please see the full Instructions for Use at NUCALA.com.
WOMAN:
Hi. Today I’m going to help show you how to prepare for and take your NUCALA injection. First, your doctor should teach you how to use the Autoinjector. You should also read the full Instructions for Use in your NUCALA carton or at NUCALA.com.
I’ll walk you through the injection like your doctor may have. If you have questions or concerns, you can always talk to your doctor about NUCALA. And remember: You got this. It shouldn’t take long for you to get more comfortable with injecting medicine yourself. Let’s get started.
First, take the carton out of the refrigerator. Check to make sure the security seals aren’t broken. If a seal is broken, don’t use the Autoinjector and safely throw the carton away.
Now, take the tray out of the carton. Peel off the clear plastic cover and, while holding the middle of the Autoinjector, carefully take it out. Before we begin, let’s look at the components of the Autoinjector.
TEXT ONSCREEN:
Do not remove the clear needle cap at this step.
[labels naming components of the Autoinjector]
Clear needle cap
Yellow needle guard (needle inside)
Stopper
Label
Inspection window (medicine inside)
WOMAN:
Don’t remove the clear needle cap at this step.
Check the expiration date on the label of your Autoinjector and make sure it hasn’t passed.
TEXT ONSCREEN:
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.
WOMAN:
Look at the medicine in the inspection window. It’s normal to see one or more air bubbles. It should be clear to pale yellow to pale brown in color. If it’s cloudy, discolored, or has particles floating in it, don’t use it.
Now put the Autoinjector down on a clean, flat surface at room temperature, away from direct sunlight and out of the reach of children. Don’t try to warm it up any other way.
TEXT ONSCREEN:
Wait 30 minutes.
WOMAN:
You’ll need to wait 30 minutes before use.
TEXT ONSCREEN:
Do not use if left out more than 8 hours.
WOMAN:
Don’t use it if it’s left out of the carton more than 8 hours.
TEXT ONSCREEN:
Supplies you need
· Alcohol swab
· Cotton ball or gauze
· Adhesive bandage
· Sharps disposal container
WOMAN:
You can take this time to gather the supplies you need: an alcohol swab; a cotton ball or gauze; an adhesive bandage; and a sharps disposal container. The Autoinjector is only for use under the skin.
TEXT ONSCREEN:
The Autoinjector is only for use under the skin (subcutaneous).
TEXT ONSCREEN:
You can inject in your thigh or abdomen.
· Do not inject where your skin is bruised, tender, red, or hard.
· Do not inject within 2 inches of your belly button.
WOMAN:
Now you can choose your injection site. You can inject yourself in your thigh or abdomen.
TEXT ONSCREEN:
Your caregiver or healthcare provider can also inject in the upper arm.
WOMAN:
Or if you’re a caregiver or healthcare provider giving the injection to someone else, you can also choose to inject in the upper arm.
TEXT ONSCREEN:
If you need more than one injection to complete your dose, leave at least 2 inches between each injection site.
WOMAN:
If you need more than one injection to complete your dose, leave at least 2 inches between each injection site.
TEXT ONSCREEN:
After cleaning the injection site, don’t touch the area again until after the injection.
WOMAN:
Now, wash your hands well with soap and water. Clean the area you want to inject by wiping your skin with an alcohol swab and allowing it to air-dry.
Now remove the clear needle cap from the Autoinjector by pulling it straight off. This could take a little force. You may see a drop of medicine at the end of the needle, and that’s normal.
TEXT ONSCREEN:
Inject within 5 minutes after you remove the clear needle cap.
WOMAN:
Always inject within 5 minutes after you remove the clear needle cap. Do not touch the yellow needle guard with your fingers, and don’t put the needle cap back onto the Autoinjector, because that could accidentally start the injection.
Touching the yellow needle guard may also cause a needle injury.
Hold the Autoinjector so you can see its inspection window. Place the Autoinjector straight onto your injection site with the yellow needle guard flat on the surface of your skin.
TEXT ONSCREEN:
· Push & Hold
· 1st Click
· 2nd Click
· Count to 5
· Lift
WOMAN:
To start your injection, push the whole Autoinjector all the way down and keep it held down against your skin. This will make the yellow needle guard slide up into the Autoinjector. If the yellow needle guard does not slide up, don’t use the Autoinjector; throw it away in a sharps disposal container.
You should hear a click to let you know your injection has started. The yellow indicator will move down through the inspection window as you receive your dose. Don’t change the position of the Autoinjector, and hold it in place. Your injection may take up to 15 seconds to complete.
Continue to hold until you hear the second click, the stopper has stopped moving, and the inspection window is filled with the yellow indicator. If you don’t hear the second click, check that the inspection window is filled with the yellow indicator, or hold the Autoinjector down for 15 seconds to make sure the injection is complete.
After you hear the second click, continue to hold and count to 5.
Then gently lift the Autoinjector away from your skin.
TEXT ONSCREEN:
Do not put the needle cap back on.
Do not rub your injection site.
WOMAN:
Do not put the needle cap back on. Don’t rub your injection site. You may see a small drop of blood, which is normal. Just press a cotton ball or gauze on the area and apply an adhesive bandage if you need it.
TEXT ONSCREEN:
· Dispose of the used Autoinjector and needle cap in an FDA-cleared sharps disposal container right away.
· Do not throw away your used sharps disposal container in your household trash unless your community guidelines permit this.
· For more information about safe sharps disposal, visit www.fda.gov/safesharpsdisposal
WOMAN:
To clean up, put your used Autoinjector in a sharps disposal container right away, and keep the container out of the reach of children.
That’s it for the injection! Once you do a few of these, it should become just another part of your treatment routine.
TEXT ONSCREEN:
844-4-NUCALA
Monday – Friday, 8 AM – 8 PM ET
Nurses from MyNUCALA.com don’t give medical advice. Talk to your healthcare provider about any disease-, treatment-, or referral-related questions.
WOMAN:
If you have any questions or need more information, talk to your doctor. You can also call the Nurse Support Line at 844-4-NUCALA to get help with your injections or any general questions you have about NUCALA. For additional resources and support, you can turn to MyNUCALA. Look for it on NUCALA.com.
Please see the full Instructions for Use at nucala.com/how-to-use
ANNOUNCER:
This is the How to Use video for the NUCALA (mepolizumab) Prefilled Syringe.
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 your NUCALA carton. Carefully follow this information so that you complete each step successfully. Your healthcare provider should show you how to use the prefilled syringe before you try to do it yourself the first time. The NUCALA prefilled syringe is only for use under the skin (subcutaneous).
ANNOUNCER:
Please read the full Instructions for Use contained in your NUCALA carton. Carefully follow this information so that you complete each step successfully. Your healthcare provider should show you how to use the prefilled syringe before you try to do it yourself the first time. The NUCALA prefilled syringe is only for use under the skin (subcutaneous).
TEXT ONSCREEN:
Know your prefilled syringe
ANNOUNCER:
Know your prefilled syringe.
TEXT ONSCREEN:
Know your 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 yourself the injection. Please examine the prefilled syringe before injecting.
TEXT ONSCREEN:
Know your 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 your 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 your injection, you will need your 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 your 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 your 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 your injection site
You can inject in your thighs or abdomen.
ANNOUNCER:
Prepare and choose your injection site. Choose where to inject on your abdomen or thigh, in the highlighted areas shown here.
TEXT ONSCREEN:
Prepare
Choose your injection site
If you are giving the injection to someone else as a caregiver or healthcare provider, you can also inject in their upper arm.
ANNOUNCER:
If you are giving the injection to someone else as a caregiver or healthcare provider, you can inject in their upper arm.
TEXT ONSCREEN:
Prepare
Choose your injection site
If you need more than one injection to complete your dose, leave at least 2 inches between each injection site.
ANNOUNCER:
If you need more than one injection to complete your dose, leave at least 2 inches between each injection site.
TEXT ONSCREEN:
Prepare
Choose your injection site
Do not inject where your skin is bruised, tender, red, or hard.
ANNOUNCER:
Do not inject where your skin is bruised, tender, red, or hard.
TEXT ONSCREEN:
Prepare
Choose your injection site
Do not inject within 2 inches of your belly button.
ANNOUNCER:
Do not inject within 2 inches of your belly button.
TEXT ONSCREEN:
Prepare
Clean your injection site
Wash your hands with soap and water.
ANNOUNCER:
Prepare and clean your injection site. Wash your hands with soap and water.
TEXT ONSCREEN:
Prepare
Clean your injection site
Clean your injection site by wiping your skin with an alcohol swab and allowing your 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 your injection site
Do not touch your cleaned injection site again until you have finished your 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 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 the medicine out, and you will not get your full dose.
ANNOUNCER:
Do not touch the white plunger at this step. This could accidentally push the medicine out, and you will not get your full dose.
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 your injection
Use your free hand to pinch the skin around your injection site. Keep pinching the skin throughout your injection.
ANNOUNCER:
Inject.
Start injection.
Use your free hand to pinch the skin around your injection site. Keep pinching throughout your injection.
TEXT ONSCREEN:
Inject
Start your 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 your 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 your injection
Slowly push down on the white plunger to inject your full dose.
ANNOUNCER:
Slowly push down on the white plunger to inject your full dose.
TEXT ONSCREEN:
Inject
Complete your injection
Make sure the white plunger is pushed all the way down until the stopper reaches the bottom of your prefilled syringe and all the medicine is injected.
ANNOUNCER:
Make sure the white plunger is pushed all the way down until the stopper reaches the bottom of your syringe and all the medicine is injected.
TEXT ONSCREEN:
Inject
Complete your 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 your 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 your syringe.
TEXT ONSCREEN:
Inject
Complete your injection
After your injection is complete, release the pinched skin.
ANNOUNCER:
After your injection is complete, release the pinched skin.
TEXT ONSCREEN:
Inject
Complete your 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 your injection
Do not rub your injection site.
ANNOUNCER:
Do not rub your injection site.
TEXT ONSCREEN:
Inject
Complete your 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 your used syringe
Put your used syringe and gray needle cap in an FDA-cleared sharps disposal container right away after use.
ANNOUNCER:
To clean up, put your used syringe and gray needle cap in a sharps disposal container right away.
TEXT ONSCREEN:
Dispose
Throw away your 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 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.
TEXT ONSCREEN:
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.
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 your doctor.
For additional resources and support visit NUCALA.com.
ANNOUNCER:
For more information or questions, talk to your doctor. Go to NUCALA.com
