Sutimlimab-jome Injection

Sutimlimab-jome injection is used to treat the breakdown of red blood cells in adults with cold agglutinin disease (CAD; an inherited condition in which the immune system mistakenly attacks and destroys its own red blood cells). Sutimlimab-jome is in a class of medications called complement inhibitors. It works by blocking the activity of the part of the immune system that may damage red blood cells.

Sutimlimab-jome comes as a solution (liquid) to be injected intravenously (into a vein) over about 1–2 hours by a healthcare provider in a medical facility. Initially, it is given once a week for the first 2 doses and then once every 2 weeks.

Sutimlimab-jome injection may cause serious or possibly life-threatening reactions that may occur while the medication is being given. Your doctor or nurse will watch you carefully while you receive each dose of sutimlimab-jome injection, and for at least 2 hours after your first dose and 1 hour after later doses. Your healthcare provider may slow or stop your infusion if you have an allergic reaction. Tell your doctor or nurse right away if you experience any of the following symptoms during or shortly after your infusion: shortness of breath; chest discomfort; rapid heartbeat; flushing; headache; dizziness; nausea; injection site redness, tenderness, or warmth; itching; rash; hives; swelling of the eyes, face, lips, tongue, or throat; hoarseness; or difficulty breathing or swallowing.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with avacopan 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 receiving sutimlimab-jome injection,

• tell your doctor and pharmacist if you are allergic to sutimlimab-jome, any other medications, or any of the ingredients in sutimlimab-jome injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while you are receiving sutimlimab-jome injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or ever have ever had an autoimmune disease (condition in which the body attacks its own organs, causing swelling and loss of function) such as lupus (condition in which the body attacks many different organs causing a variety of symptoms).
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving sutimlimab-jome injection, call your doctor.
• you should know that sutimlimab-jome injection may decrease your ability to fight infection and increase the risk that you will get a serious or life-threatening infection, including severe bacterial infections that spread throughout the body. Your doctor may tell you that you will need to be vaccinated against certain infections at least 2 weeks before you begin your treatment with sutimlimab-jome injection to decrease the risk that you will develop these types of infections. If your doctor feels that you need to begin treatment with sutimlimab-jome injection right away, you will receive your vaccination as soon as possible. Tell your doctor if you often get any type of infection or if you have or think you may have any type of infection now, including chronic infections that do not go away, such as hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). If you experience any of the following symptoms during your treatment with sutimlimab-jome, call your doctor immediately or get emergency medical help: fever; chills; headache with a stiff neck; cough; difficulty breathing; flu-like symptoms; painful, difficult, or frequent urination; warm, red, or painful skin; or other signs of infection.

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

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

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

• runny nose
• stomach pain
• nausea
• swelling of the hands, feet, ankles, or lower legs
• headache
• weakness
• color changes, numbness or tingling in fingers and toes
• blue-colored lips and skin

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

• painful or swollen joints, rash on cheeks and nose, or fever
• tiredness, shortness of breath, rapid heart rate, discolored or bloody urine

Sutimlimab-jome injecton 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).

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 and the laboratory. Your doctor may order certain lab tests to check your body's response to sutimlimab-jome injection.

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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