Sutimlimab-jome side effects

What is Sutimlimab-jome?

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

sutimlimab-jome
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.

Warnings and precautions

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:

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 side effects

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

The most frequent adverse effects are:

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 

Discontinuation

  • 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 

Label

  • 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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