Adults with cold agglutinin disease (CAD), an inherited condition in which the immune system mistakenly attacks and destroys its own red blood cells, can use sutimlimab-jome injection to reduce the need for red blood cell transfusions, which involve transferring one person’s red blood cells into the body of another person to treat severe anemia brought on by the breakdown of red blood cells. Sutimlimab-jome belongs to the class of drugs known as complement inhibitors. It functions by suppressing the immune system’s ability to attack red blood cells.

Sutimlimab-jome is a solution (liquid) that must be administered intravenously (into a vein) over the course of one to two hours by a medical professional in a facility. It is first administered once weekly for the first two doses, and then once every two weeks after that.

While the medication is being administered, sutimlimab-jome injection may result in serious or even fatal side effects. Each time you receive a sutimlimab-jome injection, as well as for at least two hours after your initial dosage and one hour after subsequent doses, a doctor or nurse will closely monitor you. If you experience an allergic response, your healthcare professional may reduce or stop your infusion. If you develop any of the following symptoms during or soon after your infusion, call your doctor or nurse straight once. Inability to breathe or swallow, shortness of breath, rapid heartbeat, flushing, headache, nausea, rash, hives, swelling of the eyes, face, lips, tongue, or throat.

You will get the manufacturer’s patient information sheet (Medication Guide) from your doctor or pharmacist when you start taking avacopan and each time you refill your prescription. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm).

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

Before receiving sutimlimab-jome injection,

• If you have an allergy to sutimlimab-jome, any other drugs, or any of the ingredients in sutimlimab-jome injection, let your doctor and pharmacist know right away. For a list of the ingredients, consult your pharmacist or the Medication Guide.
• While getting sutimlimab-jome injection, be sure to let your doctor and pharmacist know about any additional prescription and over-the-counter medicines, vitamins, dietary supplements, and herbal products you may be taking or planning to take. Your doctor might need to adjust your medication doses or keep a close eye out for any negative side effects.
• Inform your doctor if you have or have ever had an autoimmune disease, such as lupus, which causes the body to attack numerous organs and result in a wide range of symptoms. Autoimmune diseases are ones in which the body attacks its own organs, resulting in swelling and loss of function.
• Inform your doctor if you are expecting, intend to get pregnant, or are nursing a baby. Call your doctor if you fall pregnant while receiving sutimlimab-jome injectable.
• You should be aware that sutimlimab-jome injection may impair your ability to fight infection and raise your chance of contracting a serious or fatal infection, especially dangerously contagious bacterial infections. Your doctor may advise you to get immunized against specific infections at least two weeks prior to starting sutimlimab-jome injectable therapy in order to reduce the likelihood that you may contract these kinds of diseases. You will get your immunization as soon as feasible, unless your doctor determines that you need to start sutimlimab-jome injectable therapy immediately away. If you frequently get any kind of illness or if you currently have or suspect you may have any kind of infection, including chronic diseases that never go away like hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), be sure to let your doctor know. During your sutimlimab-jome treatment, call your doctor right away if you develop any of the following symptoms, or seek emergency medical attention. Flu-like symptoms, such as a fever, chills, headache with a stiff neck, cough, breathing difficulties, painful, difficult, or frequent urination, warm, red, or sore skin, or other infection-related symptoms.

Keep eating normally unless your doctor instructs you otherwise.

Call your doctor as soon as possible if you fail to show up for a sutimlimab-jome injectable visit.

Side effects from sutimlimab-jome are possible. If any of these symptoms are severe or do not go away, let your doctor know right once:

• Diarrhea
• Abdominal pain
• Heartburn
• Edema of the lower legs, ankles, feet, or hands
• Headache

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you experience any of these symptoms or any of the ones detailed in the SPECIAL PRECAUTIONS section:

• Joints that hurt or swell, rash on the cheeks and nose, or fever
• Fatigue, shortness of breath, fast heartbeat, and a bloodshot or coloured urine

Other negative effects from sutimlimab-jome injection are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online at http://www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088 if you have a serious side event.

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to the sutimlimab-jome injection, your doctor may request specific lab tests.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.