Sutimlimab

Generic name: sutimlimab [ soo-TIM-li-mab ]
Brand name: Enjaymo
Dosage form: intravenous solution (jome 1100 mg/22 mL)
Drug class: Selective immunosuppressants

Medically reviewed by Drugs.com on Jun 18, 2024. Written by Cerner Multum.

What is 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 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.

You may get infections more easily, even 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 at once 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 worsen 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 discontinued 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.

Related/similar drugs

Warnings

You may get infections more easily, even 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.

Before taking 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 current 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.

How is sutimlimab given?

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 watched for a short time to make sure 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. Keep taking these medicines for as long as your doctor has prescribed.

Sutimlimab affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis and you will need frequent medical tests.

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

Sutimlimab dosing information

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 thereafter

At least 75 kg:
-Initial dose: 7500 mg IV once a week for the first 2 weeks
-Maintenance dose: 7500 mg IV every 2 weeks thereafter

Comments:
-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

What happens if I miss a dose?

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

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid while receiving sutimlimab?

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

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.

Sutimlimab Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for sutimlimab.

Further 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.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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