NUCALA Autoinjector

Once a month. At home. On your time.
At-home NUCALA Autoinjector

At-home administration every 4 weeks

NUCALA Autoinjector is dosed as 3 separate 100-mg injections once monthly for eosinophilic granulomatosis with polyangiitis. Together, you and your doctor can decide if at-home administration with NUCALA is right for you.

Self-inject with confidence

Once you and your doctor decide that the NUCALA Autoinjector is right for you, your doctor will provide information on how to properly inject and how to monitor for allergic reactions. Sometimes, serious allergic reactions, including anaphylaxis, can occur hours or days later. Your NUCALA Autoinjector will arrive with full Instructions for Use.

Do you have more questions about NUCALA at-home administration?

Watch our instructional video, call our MyNUCALA Nurse Support Line at 844-4-NUCALA (844-468-2252), or contact your doctor’s office.

Designed with you in mind

Don’t like needles? With the NUCALA Autoinjector, you don’t have to see the needle.

Autoinjector

Prefilled syringe

How to use your prefilled Autoinjectors when your prescribed dose requires multiple injections

 

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TEXT ONSCREEN:

How to Use Your Prefilled Autoinjectors When Your Prescribed Dose Requires Multiple Injections


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.


TEXT ONSCREEN:

If you’ve been prescribed a 300 mg dose, make sure you take out and prepare three Autoinjector cartons.


WOMAN:

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

·     Once you’ve safety discarded the Autoinjector, complete any remaining injections as prescribed by your doctor following the same instructions. Be sure each injection is at least 2 inches apart.


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.


TEXT ONSCREEN:

Trademarks are owned by or licensed to the GSK group of companies.
©2020 GSK or licensor.
MPLVID220027 November 2022.
Produced in USA.

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Complete Instructions for Use
Quick Reference Guide

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 Autoinjector if it is left out of the refrigerator in the unopened carton for more than 7 days.
  • The Autoinjector 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 Autoinjector more than 1 time. Throw away the Autoinjector in an FDA-cleared sharps disposal container after your injection.

Do not share the Autoinjector with other people. You may give other people a serious infection, or you may get a serious infection from them.

Do not use the Autoinjector if it was dropped or looks damaged.

Autoinjector FAQs

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  • What should I expect when I receive my injections of NUCALA?

    You will receive NUCALA for EGPA as 3 separate 100-mg injections given at the same time in an office visit or at home every 4 weeks. You, your caregiver, or your healthcare provider will inject NUCALA just under your skin (subcutaneously) into your thigh or abdomen. Your caregiver or your healthcare provider may also inject in your upper arm. It is recommended that the individual 100-mg injections be administered at least 5 cm (approximately 2 inches) apart if more than 1 injection is administered at the same site.

    If you receive your injection at your doctor’s office, you may be asked to stay in the office so your doctor can monitor you for any allergic reactions, including anaphylaxis. Then you'll be able to leave, though sometimes serious allergic reactions can occur hours or days after you get your dose.

    If administering at home, be sure to talk to your doctor about how to monitor for allergic reactions, including anaphylaxis, that can occur after a NUCALA injection, sometimes hours or days after you get your dose.

    Tell your doctor or get emergency help right away if you have any of the following symptoms of an allergic reaction: swelling of your face, mouth, and tongue; fainting, dizziness, feeling lightheaded (low blood pressure); hives; breathing problems; or rash.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.

  • What happens if the medicine looks cloudy, the expiration date has passed, or the Autoinjector looks damaged?

    Do not use the Autoinjector. Contact GSK for more information at 1-888-825-5249.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.

  • Can I change (rotate) the injection site for the Autoinjector?

    You may change (rotate) the site (thigh, abdomen, or upper arm) or move the Autoinjector as long as you have not started pressing down. When the yellow needle guard is pressed, your injection will start right away.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.

  • Why do I need to inject within 5 minutes of removing the clear needle cap?

    This prevents the medicine from drying in the needle. It could affect how much medicine you get.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.

  • What happens if I remove the Autoinjector before the 2nd click, the stopper has stopped moving, or the inspection window is not filled with the yellow indicator?

    If this happens, you may not have received your full dose. Contact GSK for more information at 1-888-825-5249.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.

  • Whom do I contact if I need help with my injection?

    Your doctor will be able to help you with any more questions you might have.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.

  • What do I do if I miss a dose (300 mg, administered as 3 separate 100-mg injections)?

    You or your caregiver should inject your dose of NUCALA as soon as you remember. Then, continue (resume) your injection on your regular dosing schedule. If you do not notice that you have missed a dose until it is time for your next scheduled dose, then just inject the next scheduled dose as planned. If you are not sure what to do, ask your doctor, pharmacist, or nurse.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.

  • How do I store my Autoinjector?

    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. Safely throw away the prefilled Autoinjector if the unopened carton is left out of the refrigerator for more than 7 days.

    Autoinjectors must be used within 8 hours after you take them out of the carton. Safely throw away if not used within 8 hours.

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

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.

  • What if I’m going on a trip or vacation and need to take my NUCALA with me?

    Store in the refrigerator between 36°F to 46°F (2°F 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. Safely throw away the Autoinjector if the unopened carton is left out of the refrigerator for more than 7 days.

    Autoinjectors must be used within 8 hours after you take them out of the carton. Safely throw away if not used within 8 hours. 

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

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.

  • Can I reuse my Autoinjector?

    Do not use any Autoinjector more than once. Throw away the Autoinjector in an FDA-cleared sharps disposal container after your injection.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.

  • Can I share my Autoinjector?

    Do not share the Autoinjector with other people. You may give other people a serious infection, or you may get a serious infection from them.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.

  • What should I do if my Autoinjector was dropped or looks damaged?

    Do not use the Autoinjector. Contact GSK at 1-888-825-5249.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.

  • The expiration on my Autoinjector has passed. What should I do?

    Do not use the Autoinjector. Contact GSK at 1-888-825-5249.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.

  • What should I do if a security seal on the carton is broken?

    Do not use the Autoinjector. Contact GSK at 1-888-825-5249.

    Was this helpful?

    Yes, it was helpful.
    No, it was not helpful.
MyNUCALA logo

We’re here for every step of your treatment journey.

Whether you’re still thinking about starting NUCALA or have moved forward with NUCALA as a treatment option, MyNUCALA can support you along the way. MyNUCALA offers ways to help you track your progress, stay on your treatment plan, guide conversations with your doctor, and more.

Enroll today

The MyNUCALA Support Line is here to help answer questions about the self-injection process.

Call 844-4-NUCALA (844-468-2252), Monday – Friday, 8 AM – 8 PM ET.

If you have questions, contact your doctor or a healthcare provider.

Cost concerns?

Help may be available for eligible commercially insured patients. The NUCALA Copay Program helps eligible commercially insured patients with their eligible out-of-pocket costs for NUCALA.
Eligibility restrictions and program maximums apply. Visit www.GSKCopayPrograms.com for complete Program Terms and Conditions.

Apply for the Copay Program

Talk to your doctor to see if adding NUCALA is right for you.