Sutimlimab
Generic name: sutimlimab [ soo-TIM-li-mab ]
Brand name: Enjaymo
Dosage form: intravenous solution (jome 1100 mg/22 mL)
Drug class: Selective immunosuppressants
What is sutimlimab?
Sutimlimab is used to decrease the need for red blood cell transfusions in adults with cold agglutinin disease (CAD).
Sutimlimab may also be used for purposes not listed in this medication guide.
Warnings
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.
Before taking this medicine
You should not use sutimlimab if you are allergic to it or any of its ingredients.
Tell your doctor if you have ever had:
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human immunodeficiency virus (HIV);
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hepatitis B or C;
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if you have a fever or infection; or
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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.
How is sutimlimab given?
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.
What happens if I miss a dose?
Call your doctor for instructions if you miss a dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while receiving sutimlimab?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Sutimlimab side effects
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; rapid heartbeat; nausea, flushing or headache; swelling of your face, lips, tongue, or throat.
Sutimlimab may cause serious side effects. Call your doctor at once if you have:
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joint pain or swelling, rash on the cheeks and nose;
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symptoms of red blood cell breakdown--tiredness, shortness of breath, rapid heart rate, blood in your urine or dark urine; or
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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:
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cold symptoms such as stuffy nose, sneezing, sore throat, cough;
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joint pain or inflammation; or
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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.
Sutimlimab dosing information
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)
What other drugs will affect sutimlimab?
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.
Where can I get more information?
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
More about sutimlimab
- Check interactions
- Side effects
- Dosage information
- During pregnancy
- Drug class: selective immunosuppressants
- En español
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Further information
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