Receiving zilucoplan injection may increase the risk that you will develop a meningococcal infection (an infection that may affect the covering of the brain and spinal cord and/or may spread through the bloodstream) during your treatment or for some time afterward. Meningococcal infections may cause death in a short period of time. You will need to receive a meningococcal vaccine at least 2 weeks before you begin your treatment. If you have received this vaccine in the past, you may need to receive a booster dose before you begin your treatment. If your doctor feels that you need to begin treatment right away, you will receive a meningococcal vaccine as soon as possible. You may also need to take an antibiotic for as long as your doctor recommends.
Even if you receive the meningococcal vaccine, there is still a risk that you may develop meningococcal disease during or after your treatment with zilucoplan injection. If you experience any of the following symptoms, call your doctor immediately or get emergency medical help: headache that comes along with nausea or vomiting, fever, a stiff neck, or a stiff back; fever; fever and fast heart rate; rash and fever; confusion; muscle aches and other flu-like symptoms; or if your eyes are sensitive to light.
Tell your doctor if you have fever or other signs of infection before you begin your treatment with zilucoplan injection. Your doctor will not give you zilucoplan injection if you already have a meningococcal infection.
Your doctor will give you a patient safety card with information about the risk of meningococcal infection. Carry this card with you at all times during treatment and for 2 months after treatment ends. Show the card to all healthcare providers who treat you so that they will know about this risk.
A program called Zilbrysq® REMS has been set up to decrease the risks of receiving zilucoplan injection. You can only receive zilucoplan injection from a doctor who has enrolled in this program, has talked to you about the risks of meningococcal disease, has given you a patient safety card, and has made sure that you received a meningococcal vaccine.
You will be given the Medication Guide when you begin treatment with zilucoplan injection and each time you receive an injection. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.
Talk to your doctor about the risks of receiving zilucoplan injection.
Why is this medicine prescribed?
Zilucoplan injection is used to treat a certain type of myasthenia gravis (MG; a disorder of the nervous system that causes muscle weakness). Zilucoplan is in a class of medications called compliment inhibitors. It works by blocking the activity in part of the immune system that causes the symptoms of MG.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Zilucoplan injection comes as a prefilled dosing syringe to inject subcutaneously (under the skin) by yourself at home. It is injected once a day. Inject zilucoplan at around the same time every day.
Use zilucoplan injection exactly as directed. Do not use more or less of it or take it more often than prescribed by your doctor.
You or your caregiver will be shown how to use the dosing syringe by your doctor or nurse. You will be given instructions for use with the medicine. This will tell you how to inject it. Read it carefully. Ask your doctor or pharmacist if you have any questions on how to inject the medicine.
You can inject zilucoplan injection anywhere on the front of your thighs (upper leg) or stomach except the area 2 inches (5 centimeters) around your belly button. If someone else injects the medication, the back of the upper arm may also be used. Use a different site for each injection to reduce the chances of soreness or redness. Do not inject into an area where the skin is tender, bruised, red, or hard or where you have scars or stretch marks.
If the prefilled syringe has been refrigerated, place it on a flat surface to warm to room temperature for 30-45 minutes before you plan to use it. Do not try to warm the medication by heating it in a microwave, placing it in hot water, or through any other method.
Do not remove the cap from the prefilled dosing pen while the medication is warming. Remove the cap right before you inject the medication. Do not replace the cap after you remove it. Do not use the device if you drop it on the floor.
Never shake the prefilled dosing pen. This may damage the medication.
Always look at the prefilled syringe before injecting it. Check that the expiration date has not passed and that the liquid is clear and colorless or slightly yellow or brown. Do not use if it is expired, appears damaged, or if the liquid is cloudy, discolored, or contains particles.
Zilucoplan controls MG but does not cure it. Continue to use zilucoplan even if you feel well. Do not stop using zilucoplan without talking to your doctor.
What special precautions should I follow?
Before using zilucoplan injection,
- tell your doctor and pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
- tell your doctor if you or have or have ever had pancreatitis (inflammation of your pancreas).
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving zilucoplan injection, call your doctor.
- do not have any vaccinations without talking to your doctor.
- you should know that zilucoplan has caused pancreatitis (inflammation of the pancreas) and pancreatic cysts. Call your doctor right away if you have any of the following symptoms: severe stomach pain with or without vomiting that doesn't go away and may move to your back.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget to take a dose?
Inject the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not inject more than 1 dose per day.
What should I do in case of overdose?
In case of overdose, call the poison control helpline at 1-800-222-1222
. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What side effects can this medicine cause?
Zilucoplan injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- pain, bruising or redness at the site of injection
- diarrhea
- dark or thickened patches of skin
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:
- cough, fever, difficulty breathing or any signs of an infection
Zilucoplan injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone (
1-800-332-1088).What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, away from light, tightly closed, and out of reach of children. Store in the refrigerator until the date on the carton. Do not freeze. It can also be stored at room temperature in the container it came in for up to 3 months or the date on the carton, whichever is first. Protect from light. Write the date that you remove syringes from the refrigerator on the outside of the box. Store your medication only as directed. Make sure you understand how to store your medication properly.
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org
Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.
What other information should I know?
Keep all appointments with your doctor.
Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.