Zilucoplan (zil-ue-KOE-plan)

Treats myasthenia gravis.

Brand Name(s):

Zilbrysq

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in the stomach, thigh, or upper arm.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will need to be vaccinated against meningococcal infection at least 2 weeks before you start treatment with this medicine. You may also be given antibiotic medicines to prevent infections if you are to receive this medicine right away.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are red, bruised, swollen, or hard, or areas with scars or stretch marks.
• Prefilled syringe:
  • Allow 30 to 45 minutes for the medicine to warm up to room temperature. Do not warm it by using a heat source (including hot water, microwave, or direct sunlight) or in any other way.
  • Wash your hands with soap and water before and after using this medicine.
  • Check the liquid in the syringe. It should be clear and colorless. Do not use the medicine if it is cloudy, discolored, or has particles in it. Do not use the prefilled syringe if it has been cracked, leaking, or broken.
  • Remove the needle cap. Hold the syringe with one hand and pull the needle cap straight off with your other hand.
  • Do not touch or recap the needle. Do not remove any air bubbles.
  • Pinch the skin around the injection site with one hand. Insert the needle into the skin at a 45 to 90 degree angle.
  • Do not pull back on the plunger head. Do not touch the needle guard activation clips.
  • Push the plunger head all the way down while holding onto the finger grip to inject all the medicine.
  • Slowly release the plunger head by lifting your thumb. After injection, the needle guard will cover the needle and you may hear a click.
• Use a new needle and syringe each time you inject your medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose, inject it as soon as possible. Then inject the next dose at your next scheduled time. Do not inject more than 1 dose each day.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. You may store the prefilled syringe at room temperature for up to 3 months. Do not put it back in the refrigerator. Throw the medicine away if not used within 3 months or if the expiration date has passed, whichever comes first.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have a fever or any kind of infection.
• This medicine may cause the following problems:
  • Increase risk for serious infections, including meningococcal infection, influenza, pneumonia, or gonorrhea
  • Pancreatitis (inflammation of the pancreas)
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, lower back or side pain, difficult or painful urination
• Chest pain, trouble breathing
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches, headache, stiff neck
• Sudden and severe stomach pain, nausea, vomiting, lightheadedness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088