Pregnancy & Lactation: Risk data not available
What is Zilucoplan?
Zilucoplan is used to treat myasthenia gravis in adults.
Your doctor will make sure you have the correct type to be treated with zilucoplan.
Zilucoplan is available only under a special program and from a certified pharmacy. You must understand the risks and benefits of this medicine.
Zilucoplan may also be used for purposes not listed in this medication guide.
Warnings
Before you start using zilucoplan, tell your doctor if you have any signs of infection such as fever, chills, cough, body aches, tiredness, open sores or skin wounds, diarrhea, stomach pain, weight loss, painful urination, or coughing up blood.
You should not use zilucoplan if you have meningitis, an infection caused by a bacteria called Neisseria meningitidis.
Tell your doctor if you have ever had:
- active or recent infection; or
- pancreas problems.
Using zilucoplan may increase your risk of getting certain bacterial infections such as pneumonia, gonorrhea (a sexually transmitted disease), or a bloodstream infection. Ask your doctor about your individual risk and how to prevent an infection.
Make sure you are current on all vaccines that protect against serious bacterial infections including meningitis, at least 2 weeks before you start using zilucoplan. If you were vaccinated in the past, Your doctor will determine if you need additional vaccinations.
It is not known if zilucoplan will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
How should I use Zilucoplan
Use Zilucoplan (Subcutaneous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Read the Patient Wallet Card about serious side effects and learn what symptoms to watch for. Keep the card with you at all times and for 2 months after treatment.
Zilucoplan is injected under the skin, usually once per day at the same time each day.
Read and follow all Instructions for Use provided with your medicine. Your healthcare provider will teach you how to properly use this medicine by yourself and show you where to inject zilucoplan. Do not inject into the same place two times in a row. Ask your doctor or pharmacist if you don't understand these instructions or have any questions.
Prepare an injection only when you are ready to give it and make sure you understand how to use, store, and throw away zilucoplan. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.
Each prefilled syringe is for one use only. Throw away after one use, even if there is still medicine left inside. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.
Doses are based on weight. Your dose may change if you gain or lose weight.
You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.
You may be given other medications to help treat or prevent a serious infection or certain side effects. Keep taking these medicines for as long as your doctor has prescribed.
Store the medicine in the original container in the refrigerator. Protect from light and do not freeze.
Take the medicine out of the refrigerator and let it reach room temperature for 30 to 45 minutes before using. Do not warm the medicine with hot water, sunlight, or a microwave.
Zilucoplan may also be stored in the original container at room temperature away from light. Do not return the medicine to the refrigerator. Throw the medicine away after 3 months if stored at room temperature.
Use the medicine as soon as you remember, and then go back to your regular schedule. Do not use two doses at one time.
Zilucoplan side effects
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:
- fever, chills, sore throat;
- mouth sores, red or swollen gums;
- pale skin, easy bruising, unusual bleeding;
- chest discomfort, wheezing, dry cough or hack, rapid weight loss;
- signs of meningitis--headache, neck stiffness, increased sensitivity to light, nausea, vomiting, confusion, drowsiness; or
- pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting.
Common side effects may include:
- pain, bruising, swelling, or irritation where the medicine was injected;
- cold symptoms such as stuffy nose, sneezing, sore throat; or
- diarrhea.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Zilucoplan?
Avoid injecting into skin that is hard, red, bruised, swollen, tender, has scars, or stretch marks.