Overview
Sutilimab was initially developed for the treatment of cold agglutinin disease. The drug is an immunoglobulin monoclonal antibody that binds to a specific protein and inhibits the complement pathway. It was approved by the food and drug administration (FDA) in February 2022 by the USA to minimize the requirements for red blood cell transfusion in patients with cold agglutinin disease.
What Is Sutimlimab-Jome Injection?
Sutimlimab-Jome injection is the only drug that has been approved by the FDA for cold agglutinin disease. It is a prescription medicine used in adults with hemolysis due to cold agglutinin disease. Hemolysis is the destruction of blood cells in the body. The safety of the drug is yet to be known in children.
Currently, the drug is used in adults suffering from cold agglutinin disease. It is used as a replacement for blood transfusion. Transfusion is a tedious process and may require a donor and healthy blood cells so that the patient is not prone to any infections. The development of this drug has been extremely beneficial as it prevents the hemolysis process, thereby decreasing the need for blood transfusion.
Uses of Sutimlimab-Jome Injection:
The drug is specifically used to minimize blood transfusion in patients with cold agglutinin disease. Blood transfusion can have serious implications on health if it is not matched properly. A proper blood grouping test should be done, and the blood should be free of infections or diseases before transfusion. Mismatched transfusion can cause aggressive side effects on the overall health of an individual. There are no other uses of the drug currently apart from cold agglutinin disease. However, many studies and research have been conducted to understand the action of the drug in different medical conditions.
Dosage and Administration:
The Sutimlimab-Jome injection is supplied in a 22 mL single vial containing 1100 mg of the drug at a 50 mg/mL concentration. The drug is usually diluted with 0.9 percent sodium chloride before administration. The only form of drug administration is via intravenous transfusion.
The recommended dosage may vary depending on the body weight of adults suffering from cold agglutinin disease. The recommended drug dosage for those patients is mentioned below:
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39 kilograms to 75 kilograms: 6500 milligrams.
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More than 75 kilograms: 7500 milligrams.
For the first two weeks, the drug is administered every week and then every two weeks after that. The drug is administered slowly, and the patient is kept under observation during the administration to evaluate any adverse reactions or anaphylaxis.
Warnings and Precautions:
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Pediatric:
The safety and efficacy of the drug in children are yet to be established. Hence, it is not recommended for children.
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Geriatric:
Elderly individuals are more sensitive to the effects of the drug. Hence, the drug is administered only after a proper evaluation of the medical history and tolerance of the individual.
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Breastfeeding:
The risks of the drug passing through the feeding mothers and entering the children are not completely understood. Hence it is important to calculate the potential risks that outweigh the benefits while administering in feeding mothers.
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Allergies:
Inform the doctor in case of any previous allergic reaction to the Sutilimab-Jome injection or any other medications.
For Patients
What Is Cold Agglutinin Disease?
It is an uncommon form of autoimmune hemolytic anemia in which there is premature destruction of red blood cells. The disease occurs when the immune system is compromised or attacked by the body cells. The condition is called cold agglutinin disease because the antibodies are highly active at cold temperatures and are involved in the destruction of red blood cells. Red blood cells play an essential role in carrying oxygen. In general, the lifespan of a healthy red blood cell is 120 days. After this, the new cells produced by the body undergo differentiation and maturation to identify themselves as new red blood cells.
A decrease in the red blood cells may have severe ill effects on health. The condition usually affects people aged between 40 to 80 years. The disease is found to develop in one person per million every year. Since the disease affects the red blood cells, the affected individuals have compromised immunity and are highly susceptible to infections.
What Is Sutimlimab-Jome Injection, and How Does It Work?
The Sutmliab-Jome injection works by acting on the cascade pathway that is responsible for the hemolysis. Hemolysis is the process of elimination of the red blood cells from the body after its complete life cycle so that new cells can be generated. The drug inhibits the excessive hemolysis that occurs in patients with cold agglutinin disease. Thereby, the earlier method of treatment for the drug, which was blood transfusion, has been overruled.
How Should Sutimlimab-Jome Injection Be Used?
The drug has to be injected only under the supervision of a healthcare professional. The drug is injected intravenously (into the vein) for about one to two hours. The administration of the drug will be carefully monitored by the healthcare professional to observe any adverse effects. In case of allergic reactions, the drug infusion will be stopped immediately.
Missed Dose:
Since the drug is usually administered by a healthcare professional, in case of missing a dose, reschedule the appointment. Missing the dose can have a serious impact and reduce the efficacy of an individual.
What Special Dietary Instructions That Are Needed to be Followed?
Unless specifically instructed by the doctor to alter the diet, following a regular diet will be sufficient.
What Are the Special Precautions to Be Considered?
The drug can potentially cause serious infections like meningitis (inflammation of the brain), pneumonia (lung infection), and influenza (viral infection). Hence, it is crucial to inform the doctor in case of such emergencies. Also, the drug may increase the risk of autoimmune disorders. Autoimmune disorders are conditions in which the body attacks its own cells, considering them to be foreign bodies.
Who Should Avoid Sutimlimab Injection?
Pregnant and breastfeeding mothers and individuals with a history of allergic reactions and autoimmune disorders should avoid drug usage as it has serious complications and may worsen the condition. It also affects the immune system; hence necessary precautions should be taken to avoid any consequences.
What Are the Side Effects of Sutimlimab-Jome Injection?
Sutimlimab Jome injection could cause a few side effects. Therefore, it is crucial to inform the doctor in case of such side effects and take necessary action to prevent the condition from worsening. Some of the most common symptoms are listed below:
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Stomach pain.
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Swelling in the hands and feet.
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Headache.
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Weakness or fatigue.
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Sore throat.
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Stiff neck.
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Joint pain.
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Loss of appetite.
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Sweating.
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Swollen joints.
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Tiredness.
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Shortness of breath.
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Rapid heart rate.
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Hematuria (blood in urine).
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Bladder pain.
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Ear congestion.
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Muscle ache.
How Is Sutimlimab-Jome Injection Stored and Discarded?
The drug has to be stored in the refrigerator at a temperature of two to eight degrees Celsius in the carton and carefully protected from sunlight. It is important not to shake or freeze the drug. The unused portion of the drug should be discarded after a single use. Preserving the unused carton may have less efficacy.
Since the drug is available in the form of a vial after usage, carefully dispose of the drug in the biohazard disposal to prevent usage by other individuals and to keep it away from pets and children.
For Doctors
Mechanism of Action:
Sutimlimab is an Ig4 monoclonal antibody. It targets the complement C1 subunit, which is a serine protease and activates the classical complement pathway. The inhibition of complement cascade and the deposition of opsonins help prevent any further hemolysis.
Pharmacodynamics:
A single injection of the drug can impair the immune response; hence it is important for patients undergoing treatment to receive appropriate vaccination. In addition, vaccinations against encapsulated bacteria like Neisseria meningitides and Streptococcus pneumonia must be carefully monitored to prevent developing any ongoing infections.
Absorption and Volume of Distribution:
When the drug is administered, a weight-based dosage should be taken into account for better absorption and distribution of the drug. A steady-state concentration of the drug is achieved by the seventh week of the therapy. After that, the drug gets metabolized into smaller peptides and individual amino acids.
Half-Life:
The terminal elimination of Sutilimab is about 21 days. The half-life may vary depending on the dosage and distribution of the drug at a lower concentration. The drug is eliminated by proteolytic degradation; however, the process is slowed down by the Fc receptor-mediated circulation.
Preparation For Intravenous Injection:
The drug should not be shaken to minimize the foaming reaction. It is important to thoroughly check the vial before administering the drug to the patient. The presence of any particulate matter and discoloration should be inspected. Discard the drug in case of any color changes. Infuse the drug very slowly and carefully over a span of one to two hours. Constantly monitor the patient during the administration of the drug. In case the patient develops any symptoms or allergic reaction, immediately stop the drug administration and treat the symptoms specifically. After administration, carefully dispose of the vial and injection.
During administration, it is crucial to avoid any contamination; hence it is advisable to wear gloves and rub the site of injection with cotton and spirit. After proper disinfection, proceed with drug administration.
Involvement of the Healthcare Team:
Healthcare professionals play a crucial role in monitoring the condition and administering doses appropriately in affected individuals. The dosage can be accommodated depending on the overall weight of an individual to achieve maximum benefit. Properly monitoring the dosage and administration in frequent intervals can reap good results. Therefore, good teamwork is important for the success of the treatment.
Clinical Trials:
Clinical trials have been developed for the drug in treating certain conditions like hemangiomas. Most clinical trials help to assess the safety and efficacy of the drug. The phase 2 trial of the drug was useful in reducing the size of hemangiomas with a favorable safety profile. The results of the trials suggest the drug to be a promising new treatment option for hemangiomas. However, further research is required to determine the best way to use the drug in clinical practice.
