Nucala (mepolizumab) Quick Reference Guide: Injecting with the Autoinjector

1 PREP

Carefully take the Autoinjector out of its box. Keep it at room temperature, out of direct sunlight. Do not use if it has been left out for more than 8 hours.

Inspect and wait 30 minutes before use

• Check the expiration date on the label. Do not use if expired.
• Wait 30 minutes before proceeding.
• Inspect the medicine: it should be clear to pale yellow to pale brown. A few air bubbles are normal. Do not use if the medicine is cloudy, discolored, or has particles.
• Do not remove the clear needle cap at this time.
• Do not warm the autoinjector in a microwave, hot water, or sunlight.

Choose your injection site

• NUCALA is injected under the skin.
• Injection sites can be your thighs or abdomen.
• A caregiver can inject in your upper arm.
• Do not inject where skin is bruised, tender, red, or hard.
• Do not inject within 2 inches of your belly button.
• If more than one injection is needed to complete your dose, leave at least 2 inches between injection sites.

Wash your hands and clean your injection site with an alcohol swab.

2 INJECT

Pull the clear needle cap straight off. Do not press the yellow needle guard with your fingers. It's normal to see a drop of medicine at the end of the needle. Inject within 5 minutes of removing the cap.

Hold the yellow needle guard FLAT against your skin and push the Autoinjector all the way down and hold.

• Listen for the first click; injection has started. The yellow indicator will move through the inspection window. Do not lift away from the skin.
• Continue to hold down in place until injection is completed.
• Listen for the second click. Continue to hold down and count to 5, then lift off.

Two ways to know you've completed:

1. You have heard the 2nd click and counted to 5.
2. A yellow indicator has filled the inspection window.

Injection may take up to 15 seconds.

3 DISPOSE

Do not put the clear needle cap back on. Throw away your used Autoinjector in an approved sharps disposal container right after injecting.

Be sure to talk to your doctor about serious allergic reactions, including anaphylaxis, that can occur after a NUCALA injection, sometimes hours or days later.

• Do not use if security seals on Autoinjector carton are broken.
• Do not use the Autoinjector more than 1 time.
• Do not share the Autoinjector with other people.
• Do not use if it was dropped or looks damaged.
• Keep NUCALA and all medicines away from children.
• Call your doctor if you have any questions.

Watch the How-To-Use Video

Visit NUCALA.com/howto or scan a QR code with your phone's camera or QR reader to be taken to the video.

Approved Uses for NUCALA Autoinjector

NUCALA is a prescription medicine for:

• Add-on maintenance treatment of severe asthma in patients 12 years and older whose asthma is not controlled with current medicines. NUCALA helps prevent severe asthma attacks. It is not used to treat sudden breathing problems.
• Add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults whose disease is not controlled with nasal corticosteroids. NUCALA helps reduce symptoms and nasal polyp size.
• Treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA). NUCALA helps reduce symptoms and flares.
• Treatment of people 12 years and older with hypereosinophilic syndrome (HES). NUCALA helps reduce symptoms and prevent flares.

Important Safety Information

• Do not use NUCALA if you are allergic to mepolizumab or any of its ingredients.
• Do not use to treat sudden breathing problems.
• NUCALA can cause serious side effects, including allergic (hypersensitivity) reactions, such as anaphylaxis. Symptoms can occur hours or days after injection. Seek emergency help immediately if you experience swelling of your face, mouth, and tongue; breathing problems; fainting, dizziness, feeling lightheaded (low blood pressure); rash; or hives.
• Herpes zoster infections (shingles) have happened in people who received NUCALA.

Before receiving NUCALA, tell your healthcare provider about all medical conditions, including if you:

• Have a parasitic (helminth) infection.
• Are taking oral or inhaled corticosteroid medicines. Do not stop these medicines without your healthcare provider's instruction, as symptoms may return.
• Are pregnant or plan to become pregnant. It is not known if NUCALA may harm your unborn baby. A pregnancy registry is available; contact your healthcare provider or visit www.mothertobaby.org/asthma.
• Are breastfeeding or plan to breastfeed. Discuss NUCALA use and breastfeeding with your healthcare provider.
• Are taking any prescription or over-the-counter medicines, vitamins, or herbal supplements.

The most common side effects of NUCALA include headache, injection site reactions (pain, redness, swelling, itching, or burning), back pain, and tiredness (fatigue). Mouth/throat pain and joint pain have been reported with CRSwNP.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Instructions for Use

Storage Information

• Store in the refrigerator between 36°F and 46°F (2°C to 8°C).
• Keep in the original carton until use to protect from light.
• Do not freeze. Do not shake. Keep away from heat.
• An unopened carton can be stored at room temperature (up to 86°F/30°C) for up to 7 days.
• Discard the autoinjector if left out of the refrigerator in its unopened carton for more than 7 days.
• The autoinjector must be used within 8 hours after removal from the carton. Discard if not used within 8 hours.
• Safely discard expired or no longer needed medicine.
• Keep NUCALA and all medicines out of 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 use.
• Do not share the autoinjector with others, as this can cause or lead to serious infection.
• Do not use the autoinjector if it was dropped or looks damaged.

Know Your Prefilled Autoinjector

The autoinjector has several key parts:

• Label: Contains product information.
• Stopper: Seals the medication.
• Inspection window: Allows viewing of the medicine inside.
• Yellow needle guard: Covers the needle before use and retracts after injection.
• Clear needle cap: Protects the needle.
• Yellow indicator: Becomes visible when the injection is complete.

Supplies in carton

• 1 Prefilled autoinjector

Supplies not in carton

• Alcohol swab
• Cotton ball or gauze
• Adhesive bandage
• Sharps disposal container (See Step 8 for disposal instructions)

Prepare

1. Take out the prefilled autoinjector

• Take the carton from the refrigerator. Ensure security seals are intact.
• Remove the tray from the carton.
• Peel off the clear plastic cover from the tray.
• Carefully remove the autoinjector from the tray, holding it by the middle (near the inspection window).
• Place the autoinjector on a clean, flat surface at room temperature, away from direct sunlight and out of reach of children.
• Do not use if the security seal on the carton is broken. Contact GSK at 1-888-825-5249 for information.
• Do not remove the clear needle cap at this step.

2. Inspect and wait 30 minutes before use

• Check the expiration date on the autoinjector label.
• Look at the medicine in the inspection window. It should be clear to pale yellow to pale brown, without cloudiness or particles. 1 or more air bubbles are normal.
• Wait 30 minutes (but no more than 8 hours) before use.
• Do not use if the expiration date has passed, if the medicine is cloudy, discolored, or has particles. Contact GSK for more information.
• Do not warm the autoinjector in a microwave, hot water, or direct sunlight.
• Do not use if the autoinjector has been left out of the carton for more than 8 hours.

3. Choose your injection site

• You can inject in your thighs or abdomen.
• If a caregiver or healthcare provider is administering the injection, the upper arm can also be used.
• If more than 1 injection is needed for the dose, leave at least 2 inches between injection sites.
• Do not inject where your skin is bruised, tender, red, or hard.
• Do not inject within 2 inches of your belly button.

4. Clean your injection site

• Wash your hands with soap and water.
• Clean your injection site by wiping your skin with an alcohol swab and allowing it to air dry.
• Do not touch your cleaned injection site again until after the injection is finished.

Inject

5. Remove the clear needle cap

• Remove the clear needle cap by pulling it straight off, away from the yellow needle guard. This may require some force.
• A drop of medicine at the needle tip is normal.
• Ensure you inject within 5 minutes after removing the clear needle cap.
• Do not press the yellow needle guard with your fingers, as this can activate the autoinjector too soon and cause a needle injury.
• Do not put the clear needle cap back onto the autoinjector, as this could accidentally start the injection.

6. Start your injection

• Hold the autoinjector with its inspection window facing you.
• Place the autoinjector straight onto your injection site, with the yellow needle guard flat against your skin.
• To start the injection, push the autoinjector all the way down. This will cause the yellow needle guard to slide up into the autoinjector.
• You should hear the 1st click, indicating the injection has started. The yellow indicator will move down through the inspection window as the dose is administered.
• Do not lift the autoinjector at this step, as it may result in an incomplete injection.
• If the yellow needle guard does not slide up, do not use the autoinjector. Throw it away in an FDA-cleared sharps container.
• Do not try to use the autoinjector upside down with the yellow needle guard facing upward.

7. Complete your injection

• Your injection may take up to 15 seconds to complete.
• Continue to hold the autoinjector down until you hear the 2nd click, the stopper has stopped moving, and the inspection window is filled with the yellow indicator.
• After hearing the 2nd click, continue to hold and count to 5 before lifting the autoinjector away from your skin.
• If you do not hear the 2nd click: check that the inspection window is filled with the yellow indicator, or hold the autoinjector down for 15 seconds to ensure the injection is complete.
• A small drop of blood at the injection site is normal. Press a cotton ball or gauze on the area and apply an adhesive bandage if needed.
• Do not lift the autoinjector until you have heard the 2nd click, the window is filled with the yellow indicator, and you have counted to 5.
• Do not rub your injection site.
• Do not put the clear needle cap back onto the autoinjector.

Dispose

8. Throw away your used autoinjector

Put your used autoinjector and clear needle cap in an FDA-cleared sharps disposal container right away after use.

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.

When your sharps disposal container is almost full, follow your community guidelines and local laws for proper disposal. For more information about safe sharps disposal, visit the FDA's website at http://www.fda.gov/safesharpsdisposal.

• Do not throw away your used sharps disposal container in 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.

Frequently Asked Questions

1. What happens if the medicine looks cloudy, the expiration date has passed, or the prefilled autoinjector looks damaged?

   Contact GSK for more information at 1-888-825-5249.

2. Can I change (rotate) the injection site for the prefilled 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.

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

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

4. 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.

5. Who do I contact if I need help with my injection?

   Your healthcare provider will be able to help you with any more questions you might have. For more information about NUCALA, call 1-888-825-5249 or visit our website at www.NUCALA.com.