Zilucoplan Injection

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 with zilucoplan injection to decrease the risk that you will develop this type of infection. 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 with zilucoplan injection right away, you will receive your meningococcal vaccine as soon as possible.

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 of 103°F (39.4°C) or higher; 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.

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.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (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 the Food and Drug Administration (FDA) website ( http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm ) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of receiving zilucoplan injection.

Zilucoplan injection is used to treat myasthenia gravis (MG; a disorder of the nervous system that causes muscle weakness) in certain adult patients. Zilucoplan is in a class of medications called compliment inhibitors. It works by stopping the compliment system from damaging the acetylcholine receptors on the muscles, which is what causes the symptoms of MG.

Zilucoplan injection comes as a prefilled dosing pen to inject subcutaneously (under the skin) by yourself at home. It is usually injected once a day. Inject zilucoplan at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use zilucoplan exactly as directed. Do not use more or less of it or take it more often than prescribed by your doctor.

You will receive your first subcutaneous dose of zilucoplan injection in your doctor's office. After that, your doctor may allow you to inject zilucoplan yourself or have a friend or relative perform the injections. Before you use zilucoplan injection yourself the first time, read the written instructions that come with it. Ask your doctor or pharmacist to show you or the person who will be injecting the medication how to inject it.

You will receive your first subcutaneous dose of zilucoplan injection in your doctor's office. After that, your doctor may allow you to inject zilucoplan yourself or have a friend or relative perform the injections. Before you use zilucoplan injection yourself the first time, read the written instructions that come with it. Ask your doctor or pharmacist to show you or the person who will be injecting the medication how to inject it.

You can inject zilucoplan injection anywhere on front of your thighs (upper leg) or abdomen (stomach) except your navel and the area 2 inches (5 centimeters) around it. If someone else is giving you the injection, that person can also inject the medication into your upper, outer arms. 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.

You can store prefilled syringes at room temperature or in the refrigerator. If storing in the refrigerator, remove the prefilled dosing pen from the refrigerator and allow it to warm to room temperature for 30-45 minutes before using it. Take it out of its carton, and allow it to rest on a flat surface so that it can warm to room temperature. 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. You should 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 zilucoplan 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. The liquid should not contain visible particles. Do not use a dosing pen 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.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with zilucoplan injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using zilucoplan injection,

• tell your doctor and pharmacist if you are allergic to zilucoplan, any other medications, or any of the ingredients in zilucoplan injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• 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 have an infection or a fever 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, 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: abdominal pain that doesn't go away that may or may not be associated with vomiting.

Unless your doctor tells you otherwise, continue your normal diet.

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.

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

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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Zilucoplan prefilled syringes can be stored at room temperature in their original container protected from light for up to 3 months or can be stored in their original container in the refrigerator until the date on the carton. If storing syringes at room temperature, do not put them back in the refrigerator, and throw them away if not used within the 3 months of removal from the refrigerator or if the expiration date is reached, whichever is first. Make sure you write the date that you removed them 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.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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.

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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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