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Downloadable resources
Want more information about ZILBRYSQ and other important topics? These materials are a good place to start.
Patient Brochure
Learn about ZILBRYSQ dosing, effectiveness and safety, how it works, and more.
Doctor Discussion Guide
Discover how to provide your doctor with a more complete picture of how gMG impacts your life.
MG-ADL & You
See how doctors assess the many ways gMG can affect your activities of daily living.
Step-by-Step Injection Guide
Learn more about injecting ZILBRYSQ at home or on the go.
Discover ONWARD™
Learn more about ONWARD personalized support, including tools to help you start and continue ZILBRYSQ treatment, track symptoms, and see options for financial assistance.
ONWARD BrochureONWARD is provided as a service of UCB and is intended to support the appropriate use of UCB medicines. ONWARD may be amended or canceled at any time without notice. Some program and eligibility restrictions may apply.
Watch the Training Video
The ZILBRYSQ Injection Training Video will show how to properly use your medication. If you have any questions or concerns after watching it, be sure to consult with your doctor.
VO:
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.
IMPORTANT SAFETY INFORMATION
INCLUDING BOXED WARNING
What is the most important information I should know about ZILBRYSQ?
ZILBRYSQ is a medicine that affects part of your immune system. ZILBRYSQ may lower the ability of your immune system to fight certain infections.
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ZILBRYSQ increases your chance of getting serious and life-threatening meningococcal infections. Meningococcal infections may become life-threatening or fatal if not recognized and treated early.
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You must complete or update two types of meningococcal vaccines (for both serogroup B infections and serogroup A, C, W, and Y infections) at least 2 weeks before your first dose of ZILBRYSQ if you have not already had these vaccines.
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If your healthcare provider decided that urgent treatment with ZILBRYSQ is needed, you should receive meningococcal vaccination(s) as soon as possible.
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If you have not completed or updated vaccinations for meningococcal infections at least 2 weeks before your first ZILBRYSQ dose and ZILBRYSQ therapy must be started right away, you must also receive antibiotics.
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If you had a meningococcal vaccine in the past, you might need additional vaccination before starting ZILBRYSQ. Your healthcare provider will decide if you need additional meningococcal vaccination.
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Meningococcal vaccines do not prevent all meningococcal infections. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection:
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headache with nausea or vomiting
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confusion
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headache and fever
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muscle aches with flu-like symptoms
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headache with a stiff neck or stiff back
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eyes sensitive to light
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fever
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fever and a rash
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Your healthcare provider will give you a Patient Safety Card about the risk of meningococcal infection. Carry it with you at all times during treatment and for 2 months after your last ZILBRYSQ dose. Your risk of meningococcal infection may continue for several weeks after your last dose of ZILBRYSQ. It is important to show this card to any healthcare provider who treats you.
ZILBRYSQ is only available through a program called the ZILBRYSQ REMS. Before you can receive ZILBRYSQ, your healthcare provider must:
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enroll in the ZILBRYSQ REMS.
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counsel you about the risk of meningococcal infection.
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give you the Patient Guide, including information about the signs and symptoms of meningococcal infection.
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give you a Patient Safety Card about your risk of meningococcal infection, as discussed above.
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make sure that you are vaccinated with two types of meningococcal vaccines and, if needed, get revaccinated with the meningococcal vaccines. Ask your healthcare provider if you are not sure if you need to be revaccinated.
ZILBRYSQ may also increase the risk of other types of serious infections.
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ZILBRYSQ may increase your chance of getting Streptococcus pneumoniae and Haemophilus influenzae type b. Your healthcare provider will tell you if you should receive the Streptococcus pneumoniae and Haemophilus influenzae type b vaccinations.
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Certain people may have an increased risk of gonorrhea infection. Talk to your healthcare provider about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and about regular testing.
Call your healthcare provider right away if you have new signs or symptoms of infection.
Who should not use ZILBRYSQ?
Do not use ZILBRYSQ if you have a Neisseria meningitidis infection.
Before you use ZILBRYSQ, tell your healthcare provider about all of your medical conditions, including if you:
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have an infection or fever.
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are pregnant or plan to become pregnant. It is not known if ZILBRYSQ will harm your unborn baby.
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are breastfeeding or plan to breastfeed. It is not known if ZILBRYSQ passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use ZILBRYSQ.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of ZILBRYSQ?
ZILBRYSQ may cause serious side effects, including:
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See “What is the most important information I should know about ZILBRYSQ?”
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Inflammation of the pancreas (pancreatitis) and other pancreatic problems. Pancreatitis and pancreatic cysts have happened in people who use ZILBRYSQ. Your healthcare provider will do blood tests to check your pancreas before you start treatment with ZILBRYSQ.
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Call your healthcare provider right away if you have pain in your stomach area (abdomen) that will not go away. Your healthcare provider will tell you if you should stop using ZILBRYSQ. The pain may be severe or felt going from your abdomen to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
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The most common side effects of ZILBRYSQ include:
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injection site reactions.
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upper respiratory tract infections.
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diarrhea.
Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of ZILBRYSQ. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at www.fda.gov/medwatch or 1-800-FDA-10881-800-FDA-1088. You may also report side effects to UCB, Inc. by calling 1-844-599-CARE1-844-599-CARE [2273].
See the detailed Instructions for Use that comes with ZILBRYSQ for information on how to prepare and inject a dose of ZILBRYSQ, and how to properly throw away (dispose of) used ZILBRYSQ prefilled syringes.
INDICATION
What is ZILBRYSQ?
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ZILBRYSQ is a prescription medicine used to treat adults with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
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It is not known if ZILBRYSQ is safe and effective in children.
Please see the full Prescribing Information and Medication Guide for ZILBRYSQ, including the Boxed Warning regarding serious meningococcal infections. Please see the Instructions for Use for the ZILBRYSQ Single-Dose Prefilled Syringe. Talk to your healthcare provider about your condition or your treatment. For more information, go to www.ZILBRYSQ.com or call 1-844-599-22731-844-599-2273.
Interested in learning about another treatment for generalized myasthenia gravis?