Eculizumab Injection

IMPORTANT WARNING:

Receiving eculizumab 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 eculizumab 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 eculizumab right away, you will receive your meningococcal vaccine as soon as possible and 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 eculizumab injection. Call your doctor immediately or get emergency medical help if you experience any of the following: headache that comes along with nausea or vomiting, fever, a stiff neck, or a stiff back; fever; rash and fever; fever with high heart rate; 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 an eculizumab injection product. Your doctor will not give you eculizumab injection if you already have a meningococcal infection.

Your doctor will give you a patient safety card with information about the risk of developing meningococcal disease during or for a period of time after your treatment. Carry this card with you at all times during your treatment and for 3 months after your treatment. Show the card to all healthcare providers who treat you so that they will know about your risk.

Programs called Soliris REMS, BKEMV, or Epysqli REMS have been set up to decrease the risks of receiving an eculizumab injection product. You can only receive eculizumab injection from a doctor who has enrolled in one of these programs, 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 eculizumab 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 (https://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 eculizumab injection.

IMPORTANT NOTICE:

Eculizumab injection, eculizumab-aeeb injection, and eculizumab-aagh injection are biologic medications (medications made from living organisms). Eculizumab-aeeb injection and eculizumab-aagh are considered to be "biosimilar" to eculizumab injection which means they work just as well and are just as safe to use as eculizumab injection. Eculizumab injection mentioned in the monograph below refers to any of these 3 products.

WHY is this medicine prescribed?

Eculizumab injection is used to treat paroxysmal nocturnal hemoglobinuria (PNH: a type of anemia in which too many red blood cells are broken down in the body, so there are not enough healthy cells to bring oxygen to all parts of the body), atypical hemolytic uremic syndrome (aHUS; an inherited condition in which small blood clots form in the body and may cause damage to the blood vessels, blood cells, kidneys, and other parts of the body), a certain type of myasthenia gravis (MG; a disorder of the nervous system that causes muscle weakness), and a certain type of neuromyelitis optica spectrum disorder (NMOSD; an autoimmune disorder of the nervous system that affects eye nerves and the spinal cord). Eculizumab injection is in a group of medications called immunotherapy. Eculizumab injection works by blocking the activity of the part of the immune system that may damage blood cells in people with PNH and that causes clots to form in people with aHUS. It also works by blocking the activity of the part of the immune system that may damage certain parts of the central nervous system in people with NMOSD or by disrupting communication between nerves and muscles in people with 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?

Eculizumab injection come as a solution (liquid) to be injected intravenously (into a vein) over at least 35 minutes by a doctor or nurse in a medical office. It is usually given to adults once a week for 5 weeks and then once every other week. Children may receive eculizumab injection on a different schedule, depending on their age and body weight. Extra doses of eculizumab injection are also given before or after certain other treatments for PNH , aHUS, MG, or NMOSD.

Your doctor will probably start you on a low dose of eculizumab injection and increase your dose after 4 weeks.

You will be watched closely during and for 1 hour after you recieve the medication to be sure youare not having a serious reaction. Tell your doctor immediately if you experience any of the following: chest pain; feeling faint; rash; hives; swelling of the eyes, face, lips, tongue, or throat; hoarseness; or difficulty breathing or swallowing. Your doctor may slow or stop your infusion if you experience any of these side effects.

What SPECIAL PRECAUTIONS should I follow?

Before receiving an eculizumab injection,

• tell your doctor and pharmacist if you are allergic to eculizumab injection, any other medications, or any of the ingredients in eculizumab injection products. 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. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while receiving an eculizumab injection product, call your doctor.

• if your child will be treated with an eculizumab injection product, your child should be vaccinated against Streptococcus pneumoniae and Haemophilus influenza type b (Hib) before beginning treatment. Talk to your child's doctor about giving your child these vaccinations and any other vaccinations your child needs.

• if you are being treated for PNH, you should know that your condition may cause too many red blood cells to break down after you stop receiving the medication. Your doctor will monitor you carefully and may order laboratory tests during the first 8 weeks after you finish your treatment. Call your doctor right away if you develop any of the following: confusion, chest pain, difficulty breathing, or any other unusual symptoms.

• if you are being treated for aHUS, you should know that your condition may cause blood clots to form in your body after you stop receiving the medication. Your doctor will monitor you carefully and may order laboratory tests during the first 12 weeks after you finish your treatment. Call your doctor right away if you develop any of the following: sudden trouble speaking or understanding speech; confusion; sudden weakness or numbness of an arm or leg (especially on one side of the body) or of the face; sudden trouble walking, dizziness, loss of balance or coordination; fainting; seizures; chest pain; difficulty breathing; swelling in the arms or legs; or any other unusual symptoms.

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?

If you miss an appointment to receive a dose of eculizumab injection, call your doctor right away.

What SIDE EFFECTS can this medicine cause?

Eculizumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• runny nose
• pain or swelling in the nose or throat
• cough
• difficulty falling asleep or staying asleep
• excessive tiredness
• dizziness
• pain in the arms, legs, muscles, or joints
• nausea, vomiting, or diarrhea
• stomach pain
• painful or difficult urination

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment:

• swelling of the arms, hands, feet, ankles, or lower legs
• pale skin, weakness, fast heartbeat, or shortness of breath

Eculizumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving 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 OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to eculizumab injection.

Ask your pharmacist any questions you have about eculizumab injection.

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.