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Sutimlimab-jome side effects

  • Generic Name: sutimlimab-jome
  • Dosage Form: injection, for intravenous use
  • Brand name: Enjaymo
  • Medically reviewed by A Rash MD. Updated on March 23, 2022.

What is Sutimlimab-jome?


Sutimlimab-jome side effects  are unwanted reactions that  may be experienced while using this drug

Sutimlimab-jome is a prescription medication that is used to reduce the need for transfusion of red blood cells due to the loss of red blood cells (hemolysis) in patients with cold agglutinin disorder (CAD).

It isn’t clear whether this medicine has been proven safe or effective for children.

Sutimlimab-jome, a classical complement inhibitor, is a humanized monoclonal antibody generated in vitro using standard mammalian cell culture procedures and expressed via recombinant in Chinese hamster ovary (CHO) cells. Sutimlimab-jome is made up of two different heterodimers. Each heterodimer is made up of two polypeptide chains, one heavy and one light. Each heavy chain (H-chain) has 445 amino acids, whereas each light chain (L-chain) includes 216. Sutimlimab-jome is a protein with a molecular weight of 147 kDa.

Sutimlimab-jome injection is a preservative-free, sterile, clear to slightly opalescent, colorless to slightly yellow intravenous solution. Each single-dose vial contains 1,100 mg sutimlimab-jome at a 50 mg/mL concentration and pH of 6.1. Polysorbate 80 (0.2 mg), sodium chloride (8.18 mg), sodium phosphate dibasic heptahydrate (0.48 mg), sodium phosphate monobasic monohydrate (1.13 mg), and Water for Injection, USP are all included in each mL of sutimlimab-jome.

Mechanism of Action

Cold Agglutinin Disease

Sutimlimab-jome is a monoclonal antibody (mAb) that binds to complement protein component 1, s subcomponent (C1s), a serine protease that cleaves C4. It inhibits the classical complement pathway (CP) and selectively binds to C1s, a serine protease that cleaves C4. The lectin and alternative routes are not inhibited by sutimlimab-jome. Inhibition of the conventional complement pathway at the C1s level limits the deposition of complement opsonins on the surface of RBCs, preventing hemolysis in CAD patients.

Important information

Sutimlimab-jome may cause severe side effects, such as:

Serious illnesses. Sutimlimab-jome is a prescription medicine that impacts the immune system. Sutimlimab-jome could reduce the capability of the immune system to fight off infections. The people who take it may have a greater chance of contracting infections caused by specific kinds of bacteria like Neisseria meningitides Streptococcus pneumoniae and Haemophilus influenza. These infections can be severe or even life-threatening. Some infections could rapidly become life-threatening or even cause death if they are not identified and treated promptly.

  • It is recommended to get vaccinated against infections caused due to certain varieties of bacteria. This should be done at least two weeks prior to your initial dose of the Sutimlimab-jome. It is possible that you will require additional vaccinations as part of your treatment.
  • If your physician decides urgent treatment using Sutimlimab-jome is required then you must receive your vaccinations in the earliest time possible.
  • Vaccinations can reduce the risk of getting these infections however, they cannot prevent all illnesses. Consult your doctor or seek medical assistance immediately if you experience any new symptoms or signs of infection, such as:
    • The fever
    • severe headache, stiff back or neck
    • chest pain
    • discomfort during urination, or having to urinate more frequently than normal
    • Trouble breathing or cough
    • Influenza-like symptoms
    • Redness, pain, or swelling of the skin

Warnings and precautions

  • Severe Infections: Make sure the patients have been vaccinated against bacteria that have been encapsulated. Be on the lookout for early indicators and signs of infection.
  • Infusion-related reactions: Check patients for reactions related to infusions or reactions, stop the treatment if one occurs and implement the appropriate medical treatment as required.
  • Risque in Autoimmune Disease: Monitor patients for symptoms and signs, and treat them medically.
  • Recurrent Hemolysis after Sutimlimab-jome discontinuation Check patients for hemolysis-related signs and symptoms in the event that treatment with Sutimlimab-jome has been stopped

Who shouldn’t receive Sutimlimab-jome?

Don’t take Sutimlimab-jome if you are allergic to sutimlimab or any of the other ingredients. Check out the bottom of this page to find a full list of the ingredients.

Prior to receiving Sutimlimab-jome 

Before you receive treatment, inform your healthcare professional about your medical conditions, especially the following:

  • are suffering from a fever or illness, such as the presence of the human immunodeficiency virus (HIV) or hepatitis B or C.
  • are afflicted with an autoimmune condition like systemic lupus-erythematosus (SLE) which is also known as lupus.
  • Are pregnant or planning to be pregnant or plan to. It isn’t known whether the drug Sutimlimab-jome could cause harm to your baby.
  • If you are nursing or planning to or plan to. It’s not clear whether Sutimlimab-jome gets into your milk. It is recommended to talk with your healthcare professional regarding the best method to feed your child while you are undergoing treatment.

What other medications can have an effect on Sutimlimab-jome?

Inform your doctor about the medications you are taking, which includes prescription and non-prescription medications as well as vitamins or herbal remedies.

Take note of the medicines you take. Make a list to show your doctor and pharmacist if you are given a new medication.

How to receive Sutimlimab-jome?

  • Sutimlimab-jome is administered through infusions intravenously (I.V.) infusions, which usually last for between 1 and 2 hours.
  • It is typical to receive an initial dose, which is followed by another dose one week later. After 2 weeks of your second dose, you’ll be receiving two infusions every two weeks.
  • Following your first infusion, You should be watched for allergic and infusion reactions for at least two hours. For any subsequent infusions, you must be watched for any reactions that occur during the infusion for one hour.
  • If you have CAD, and you cease receiving Sutimlimab-jome Your healthcare provider will closely watch you to see if your symptoms return when you stop Enjaymo. The stopping of Sutimlimab-jome could cause the degeneration of the red blood cells in your body because of CAD to come back. Problems or symptoms that may be caused by the breakdown of red blood cells are:
    • tiredness
    • breathlessness
    • heart rate rapid
    • the presence of blood in your urine, or dark urine
  • If you do not receive an infusion, contact your healthcare provider immediately.

Sutimlimab-jome side effects

Sutimlimab-jome may cause serious side effects, which include:

  • Check out for important information.
  • Infusion-related reactions. Treatment with Sutimlimab-jome can trigger reactions related to the infusion, including allergic reactions that can be life-threatening or serious. Your healthcare provider could reduce or end your infusion if they suspect you experience an infusion-related reaction. They will treat your symptoms as required. Contact your healthcare professional right immediately if you notice any symptoms after your infusion, which could indicate that you’re experiencing an infusion-related reaction. These include:
  • The risk of developing an autoimmune disease. Sutimlimab-jome can increase the risk of developing an autoimmune condition like SLE. Talk to your healthcare professional and seek medical attention in the event that you exhibit any signs of SLE such as:
    • joint inflammation or pain
    • Acne on the cheeks and nose
    • Unknown cause of fever that is not explained

The most frequent adverse effects are:

  • respiratory tract infection
  • virus infection
  • diarrhea
  • indigestion
  • cough
  • joint pain
  • joint pain (arthritis)
  • swelling of the lower leg as well as ankles and feet

This is not the only list of possible adverse consequences. Contact your doctor to get medical advice on adverse effects. You can report any adverse reactions to the FDA at 1-800-FDA-1088.

Patient counseling

Inform the patient to read the FDA-approved labeling for patients (Medication Guidance).

Severe Infections

  • Inform patients about the higher risk of infection, including infection caused by encapsulated bacteria, such as Neisseria meningitides Streptococcus pneumoniae and Haemophilus influenza. These infections could be severe or even life-threatening. Instruct patients they have to get vaccinations against these bacteria in accordance with current guidelines in medicine prior to the beginning of treatment and while using Sutimlimab-jome. Instruct patients about the signs of infections and urge that they seek immediate medical attention should any new signs of infection develop 

Infusion-Related Reactions

  • Inform patients that the administration of Sutimlimab-jome can cause hypersensitivity reactions that are triggered by infusions. Hypersensitivity reactions can be severe or even life-threatening (e.g. anaphylaxis). Inform patients about the signs of reactions resulting from infusions, and encourage that they seek medical attention when symptoms related to infusions develop

The risk of Autoimmune Disease

  • Inform patients that there could be a higher risk for developing an auto-immune condition like SLE in the course of Sutimlimab-jome treatment. Inform patients about symptoms and signs of SLE and be sure to report any new signs or symptoms of SLE or seek medical assistance 


  • Inform patients suffering from CAD that they could be affected by hemolysis caused by CAD if Sutimlimab-jome is stopped. Also, they must be closely followed by their physician in the aftermath of Sutimlimab-jomecessation 


  • Rx only
  • Enjaymo(sutimlimab-jome)
  • Injection 1,100 mg/22 mL (50 mg/mL)
  • For Intravenous Infusion After Dilution
  • One single-dose vial
    Discard unused portion


PRINCIPAL DISPLAY PANEL - 1,100 mg/22 mL Vial Carton

More details

Always consult your physician to make sure the information presented on this site is appropriate to your particular situation.

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