Sutimlimab

Generic name: Sutimlimab
Brand names: Enjaymo
Dosage form: intravenous solution (jome 1100 mg/22 mL)
Drug class: Selective immunosuppressants

Usage of Sutimlimab

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.

Sutimlimab side effects

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.

Before taking Sutimlimab

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.

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How to use Sutimlimab

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

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.

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.

Disclaimer

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