How to use ZILBRYSQ

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Welcome. Your doctor has prescribed ZILBRYSQ (zilucoplan) to treat your generalized myasthenia gravis (gMG). While this video will demonstrate how to use ZILBRYSQ, you should read the Instructions for Use and Medication Guide before you start using ZILBRYSQ and each time you get a refill; there may be new information.

This information does not take the place of talking with your healthcare provider about your medical condition or treatment. If you and your family members or caregivers have any questions about ZILBRYSQ or how to administer it, ask your healthcare provider or pharmacist.

ZILBRYSQ is a prescription medicine used for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

ZILBRYSQ is a medicine that affects part of your immune system. ZILBRYSQ may lower the ability of your immune system to fight certain infections. ZILBRYSQ increases your chance of getting serious and life-threatening meningococcal infections.

You must complete or update meningococcal vaccines at least 2 weeks before your first dose of ZILBRYSQ. If you have not completed or updated vaccinations for meningococcal infections at least two weeks before your first ZILBRYSQ dose and ZILBRYSQ therapy must be started right away, you must also receive antibiotics.

Call your healthcare provider or get emergency medical care right away if you get any signs and symptoms of a meningococcal infection.

Do not use ZILBRYSQ if you have a Neisseria meningitidis infection. ZILBRYSQ may also increase the risk of other types of serious infections. Call your healthcare provider right away if you have new signs or symptoms of infection. Pancreatitis and pancreatic cysts have happened in people who use ZILBRYSQ. The most common side effects of ZILBRYSQ include injection site reactions, upper respiratory tract infections, and diarrhea.

Please see the additional Important Safety Information for ZILBRYSQ at the end of the video.

This video will take you through the process of using ZILBRYSQ prefilled syringes, starting with storage considerations, then preparation, injecting, and disposal.

Please note the different sections of this video for future reference.

Review this Instructions for Use video before using the ZILBRYSQ prefilled syringe. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. See the medication guide that comes with ZILBRYSQ for important information.

Your healthcare provider should show you how to prepare and inject ZILBRYSQ prefilled syringe properly before you use it for the first time. Do not inject yourself or someone else until you have been shown how to inject ZILBRYSQ correctly. Keep this instructional video bookmarked and refer to it as needed.

For general questions or help, please call your healthcare provider or UCBCares at 1-844-599-CARE, 1-844-599-2273.

Prior to preparing for your self-injection, you will need to know how to store your ZILBRYSQ prefilled syringes.

• You should store ZILBRYSQ prefilled syringes in a refrigerator between 36°F to 46°F (2°C to 8°C) until the expiration date on the carton. Do not freeze ZILBRYSQ.
• ZILBRYSQ prefilled syringes may be stored at room temperature up to 86°F (30°C) in the original carton for a single period of up to 3 months. Write the date you removed the prefilled syringes from the refrigerator in the space provided on the carton. After ZILBRYSQ prefilled syringes have been stored at room temperature, do not place them back in the refrigerator. Throw them away if not used within 3 months or if the expiration date has passed, whichever occurs first.
• You should keep the ZILBRYSQ prefilled syringes in the original carton before use.
• You should keep ZILBRYSQ prefilled syringes and all medicines out of the reach of children.

Here are important items you need to know before you inject ZILBRYSQ.

• Do not use ZILBRYSQ if the expiration date on the packaging has passed or the carton seals have been broken.
• Do not reuse the ZILBRYSQ prefilled syringe. The prefilled syringe is for 1-time (single use) only. You may get an infection.
• Do not inject ZILBRYSQ more than 1 time per day.
• Do not miss any doses of ZILBRYSQ. If you miss your ZILBRYSQ dose, inject a dose as soon as possible. Then, inject the next dose at your scheduled time. Do not inject more than 1 dose each day.
• Do not use the ZILBRYSQ prefilled syringe if it has been dropped.
• Do not remove the needle cap from the ZILBRYSQ prefilled syringe until you are ready to inject.
• Do not insert the needle into the skin more than 1 time because this may bend or break the needle, causing trauma to the tissue.
• Do not pull back on the ZILBRYSQ prefilled syringe plunger head at any time because this can break the prefilled syringe.
• Do not touch the needle guard activation clips at any time because this can cause the early activation of the needle guard.

Prior to self-injecting, note the different parts of your ZILBRYSQ prefilled syringe.

Please do allow a little time to get ready to “prepare” for your self-injection. In this section, we will go over step by step on how to prepare for your self-injection.

Step 1: Take Out the ZILBRYSQ Prefilled Syringes
If the ZILBRYSQ prefilled syringes are stored in the refrigerator: Take the ZILBRYSQ prefilled syringes carton out of the refrigerator and remove 1 prefilled syringe from the carton. Grasp the prefilled syringe body. Carefully lift the prefilled syringe straight up out of the tray. Put the rest of the prefilled syringes in the carton back in the refrigerator. Before you inject ZILBRYSQ, let the prefilled syringe warm up to room temperature on a clean flat surface for 30 to 45 minutes. This will help to reduce discomfort when injecting. Do not warm the ZILBRYSQ prefilled syringe in any other way (for example in a microwave, in hot water, or in direct sunlight). Do not remove the needle cap from the prefilled syringe until you are ready to inject.

If the ZILBRYSQ prefilled syringes are stored at room temperature: Remove 1 ZILBRYSQ prefilled syringe from the carton.
Grasp the prefilled syringe body. Carefully lift the prefilled syringe straight up out of the tray. Any remaining prefilled syringes in the carton should not be placed in the refrigerator after it has been stored at room temperature.

Step 2: Inspect the ZILBRYSQ Prefilled Syringes

• Check the prefilled syringe for damage.
• Do not use if any part of the prefilled syringe appears to be cracked, leaking, or broken.
• Check that the needle cap is not cracked or broken and attached to the prefilled syringe.
• Do not use if the needle cap is missing or not securely attached.
• Check the expiration date and medicine name (ZILBRYSQ) on the prefilled syringe label.
• Do not use if the expiration date printed on the prefilled syringe has passed.
• Do not use if the word ZILBRYSQ does not appear on the prefilled syringe.
• Check the dose appearing on the label and make sure it matches your prescribed dose.
• Do not use if the dose does not match your prescribed dose.
• Check the medicine inside the prefilled syringe. The medicine should be clear to almost clear and colorless. It is normal to see air bubbles in the prefilled syringe.
• Do not use if the medicine is cloudy, discolored, or contains floating particles.
• The color of the syringe plunger may vary based on the dosage you have been prescribed.

Step 3: Gather Supplies
Wash your hands with soap and water and dry them with a clean towel. Gather the following supplies on a clean, flat surface:

• 1 ZILBRYSQ prefilled syringe
• 1 alcohol wipe*
• 1 cotton ball or gauze pad*
• 1 adhesive bandage*
• 1 sharps disposal or puncture-resistant container* (See Step 12 for instructions on throwing away the syringes)

But note that the items indicated with an asterisk are not supplied with your prefilled syringes.

Step 4: Choose Your Injection Site
Choose an injection site from the highlighted areas:

• The stomach (abdomen), except for the 2-inch area around the belly button (navel)
• The front of the thighs
• The back of the upper arms (only if someone else is giving you the injection)

Choose a different site each time you give yourself an injection. If you want to use the same injection site, make sure it is at least 1 inch from a spot you used before.

Do not inject ZILBRYSQ into an area that is red, tender, bruised, swollen, hard or that has scars or stretch marks.

Step 5: Clean Your Injection Site

• Clean the injection site using an alcohol wipe.
• Let the skin dry for 10 seconds before injecting.
• Do not touch the injection site again before giving your injection.

In this next section, we will go over step by step how to self-inject.

Step 6: Remove the Needle Cap
Hold the body of the ZILBRYSQ prefilled syringe with one hand and pull the needle cap straight off with your other hand.

Throw away (discard) the needle cap into your household trash or a sharps disposal container. Do not touch the needle or let it touch anything.

Do not recap the needle at any time to avoid injury.

Do not try to remove any air bubbles from the ZILBRYSQ prefilled syringe. Air bubbles will not affect your dose and will not harm you. This is normal. You can continue to take your injection.

Step 7: Pinch Your Injection Site
Use your other hand to pinch the area of cleaned skin and hold it firmly.

Step 8: Insert the Needle
Insert the entire needle into the pinched skin at a 45° to 90° angle. When the needle is fully inserted, hold the ZILBRYSQ prefilled syringe in place.

Do not pull back on the plunger head at any time because this could break the prefilled syringe.

Do not touch the needle guard activation clips.

Step 9: Release the Pinched Skin
When the needle is fully inserted, hold the ZILBRYSQ prefilled syringe in place and release the pinched skin.

Do not reinsert the needle into the skin if the needle is pulled out when releasing the skin. If this happens, safely throw away (dispose of) the syringe in a sharps disposal container and get a new ZILBRYSQ prefilled syringe to give the injection.

Step 10: Inject the Medicine
Push the plunger head all the way down while holding onto the finger grip to inject all the medicine.

Step 11: Release the Plunger Head
Slowly release the plunger head by lifting your thumb. After a complete injection, the needle guard will cover the needle and you may hear a click.

In this last section, we will go over step by step how to safely dispose of the used ZILBRYSQ prefilled syringe and clean up after your self-injection.

Step 12:
Throw away (dispose of) the used ZILBRYSQ prefilled syringe into a sharps disposal container right away.

Do not throw away (dispose of) the ZILBRYSQ prefilled syringe in your household trash. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

• Made of a heavy-duty plastic
• Can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
• Upright and stable during use
• Leak-resistant, and properly labeled to warn of hazardous waste inside the container

Do not throw away (dispose of) your used sharps disposal container in your household trash unless your community guidelines permit this.

Do not recycle your used sharps disposal container. Always keep the sharps disposal container out of the reach of children.

Note: When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away your used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the FDA’s website at: www.fda.gov/safesharpsdisposal.

Step 13: Examine the Injection Site
Press a cotton ball or gauze pad over the injection site and hold it for 10 seconds.

Do not rub the injection site. You may have slight bleeding. This is normal. Apply an adhesive bandage if needed.

The injection is complete. For more information or help, contact your healthcare provider. If you have any questions, call UCBCares at 1-844-599-CARE, 1-844-599-2273 or visit www.AskUCBCares.com.

This step-by-step process should also be followed similarly if someone else is giving you the injection.

Well done! You've completed your injection. Consider using a tracking diary or tracking app to record the area you used for this injection so you can choose a different area for your next one. Consider using the Myasthenia Gravis Activities of Daily Living, or MG-ADL, scale to track your symptoms regularly and help tell your doctor how symptoms are impacting your life. Ask your doctor how often to track your scores. Enroll in the ONWARD™ program to receive personalized support during your treatment.