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

Sutimlimab may also be used for purposes not listed in this medication guide.

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 sutimlimab.

Call your doctor at once if you have signs of an infection: fever, severe headache with stiff neck or back, painful urination or urinating more than usual, cough or problems breathing, symptoms similar to the flu, or pain, redness, or swelling of the skin.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Sutimlimab is injected into a vein by a healthcare provider. sutimlimab is usually given over 1 to 2 hours.

You will usually receive a starting dose of sutimlimab, followed by a second dose 1 week later. Two weeks after your second dose, you will receive an infusion every 2 weeks.

You will be watched for 1 to 2 hours to make sure you do not have an allergic reaction.

You will be watched closely after you stop using sutimlimab. If you have CAD, stopping this medicine may cause the breakdown of your red blood cells.

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.

Usual Adult Dose for Hemolytic Anemia:

Recommended dosage is based on body weight:
39 to less than 75 kg: 6500 mg IV
75 kg or more: 7500 mg IV

Comments:
-Is recommended to administer treatment weekly for the first 2 weeks, and every 2 weeks thereafter.
-It is recommended to administer treatment at specified dosage time points, or within 2 days of these time points.

Use: To decrease the need for RBC transfusion due to hemolysis in adults with cold agglutinin disease (CAD)

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

Tell your doctor if you have ever had:

• human immunodeficiency virus (HIV);

• hepatitis B or C;

• if you have a fever or infection; or

• if you have an autoimmune disease such as lupus.

Sutimlimab can weaken your immune system and may interfere with your body's ability to fight infections. Ask a healthcare provider about your individual risk.

Tell your doctor if you are pregnant or plan to become pregnant or breastfeeding or plan to breastfeed.

Call your doctor for instructions if you miss an appointment for your sutimlimab injection.

In a medical setting an overdose would be treated quickly.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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

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

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

• joint pain or swelling, rash on the cheeks and nose, unexplained fever;

• symptoms of red blood cell breakdown--tiredness, shortness of breath, rapid heart rate, blood in your urine or dark urine; or

• signs of an infection--fever, severe headache with stiff neck or back, painful urination or urinating more than usual, cough or problems breathing, symptoms similar to the flu, or pain, redness, or swelling of the skin.

Common side effects of sutimlimab may include:

• diarrhea, indigestion;

• respiratory or viral infection;

• cold symptoms such as stuffy nose, sneezing, sore throat, cough;

• joint pain or inflammation; or

• swelling of the lower legs, ankles, and feet.

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.

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.