Sutimlimab

Sutimlimab is used to treat the breakdown of red blood cells (hemolysis) in adults with cold agglutinin disease (CAD).

Sutimlimab may also be used for other reasons not mentioned in this medication guide.

Sutimlimab is given as an infusion into a vein by a healthcare provider. This medicine is usually given over 1 to 2 hours.

For the first two doses, sutimlimab is usually given once weekly. Later doses are then given once every 2 weeks. Your doctor will determine your treatment schedule.

You will be monitored for a short time to ensure you do not have an allergic reaction.

You may be given other medications to help treat or prevent a serious infection or certain side effects. Continue taking these medicines for as long as your doctor has prescribed.

Sutimlimab affects your immune system. You may get infections more easily, including serious or fatal infections. Your doctor will need to check you regularly, and you will need frequent medical tests.

Your doctor will monitor you closely if you stop using sutimlimab. Your condition may get worse if you stop using sutimlimab suddenly. Follow your doctor's instructions.

You may get infections more easily, including serious or fatal infections. Call your doctor if you have flu symptoms, cough, night sweats, neck stiffness, confusion, or vision problems.

You will need to get vaccinated at least 2 weeks before your first dose of sutimlimab. You may need to get additional vaccines during your treatment with this medicine.

You should not receive sutimlimab if you are allergic to it or any of its ingredients.

Tell your doctor if you have or have ever had:

• a chronic or recent infection;
• fever;
• human immunodeficiency virus (HIV), hepatitis B or C;
• an autoimmune disease such as lupus; or
• recently received a vaccine or are scheduled to receive a vaccine.

Make sure you are up to date on all vaccines that protect against serious bacterial infections at least 2 weeks before you start using sutimlimab. If you were vaccinated in the past, you may need additional vaccinations or booster doses.

It is not known if sutimlimab 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 sutimlimab.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Some side effects may happen during the injection. Tell your medical caregiver if you feel dizzy, nauseous, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

You may get infections more easily, including 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; or
• chest discomfort, wheezing, dry cough or hack, rapid weight loss.

Sutimlimab may cause serious side effects. Call your doctor immediately if you have:

• new or worsening symptoms of lupus—joint pain or swelling with fever, headaches, chest pain, shortness of breath, skin rash on your face or arms that gets worse in sunlight.

Your condition may get worse if you stop receiving sutimlimab. Tell your doctor if you have symptoms of red blood cell breakdown such as tiredness, shortness of breath, rapid heart rate, blood in your urine, or dark urine.

Your treatment may be delayed or permanently stopped if you have certain side effects.

Common side effects of sutimlimab may include:

• dizziness, feeling tired or weak;
• cold symptoms such as stuffy or runny nose, sneezing, sore throat, cough;
• headache, nausea;
• blue-colored lips and skin;
• joint pain;
• increased blood pressure;
• pain and burning when you urinate;
• numbness, cold feeling, or pale appearance of your fingers or toes;
• swelling in your hands or lower legs; or
• infection.

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.

Usual Adult Dose for Hemolytic Anemia:

39 to less than 75 kg:-Initial dose: 6500 mg IV once a week for the first 2 weeks-Maintenance dose: 6500 mg IV every 2 weeks thereafterAt least 75 kg:-Initial dose: 7500 mg IV once a week for the first 2 weeks-Maintenance dose: 7500 mg IV every 2 weeks thereafterComments:-This drug should be administered at the recommended dosage regimen time points or within 2 days of these time points.Use: For the treatment of hemolysis in patients with cold agglutinin disease

Call your doctor for guidance if you miss your appointment for the sutimlimab injection.

In a medical setting, an overdose would be treated right away.

Follow your doctor's instructions regarding any limitations on food, drinks, or activities.

Other drugs may affect sutimlimab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.