Generic Name: sutimlimab-jome
Dosage Form: injection, for intravenous use
Medically reviewed by A Rash MD. Updated on March 23, 2022.
What is Enjaymo?
Enjaymo 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.
ENJAYMO (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 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.
Enjaymo may cause severe side effects, such as:
serious illnesses. Enjaymo is a prescription medicine that impacts the immune system. Enjaymo 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 Enjaymo. It is possible that you will require additional vaccinations as part of your treatment.
- If your physician decides urgent treatment using Enjaymo 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 ENJAYMO discontinuation Check patients for hemolysis-related signs and symptoms in the event that treatment with ENJAYMO has been stopped
Who shouldn’t receive Enjaymo?
Don’t take Enjaymo 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 Enjaymo
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 Enjaymo could cause harm to your baby.
- If you are nursing or planning to or plan to. It’s not clear whether Enjaymo 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 Enjaymo?
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 Enjaymo?
- Enjaymo 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 Enjaymo Your healthcare provider will closely watch you see if your symptoms return when you stop Enjaymo. The stopping of Enjaymo 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:
- 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.
Dosage and administration
Inoculate patients against encapsulated bacterial infections at least two weeks prior to starting ENJAYMO therapy in accordance with the most recent Advisory Commission for Immunization Practices (ACIP) guidelines for patients suffering from ongoing deficiencies in the complement system. If immediate treatment with ENJAYMO is required in a non-vaccinated patient, give vaccine(s) immediately is.
The Recommended Dosage Recommendation
The dosage recommended for ENJAYMO for patients suffering from CAD is determined by body weight. For patients weighing 39kg or less than 75 kg The recommended dosage is 6,500 mg. For patients who weigh over 75 kilograms, the suggested dosage of 7,500 mg. Use ENJAYMO every week intravenously for the first 2 weeks, then once every two weeks after that. Take ENJAYMO according to the dose regimen times, at least within 2 days from these time intervals.
If you miss a dose If a dose is missed, take it as soon as is possible. Afterward, it is recommended to resume doses at intervals of two weeks. If the time period after the last dose is greater than 17 days, you should administer ENJAYMO daily for two weeks. Then, the administration occurs every two weeks after that.
The preparation and the administration
ENJAYMO is for intravenous injections only.
Each bottle of ENJAYMO is designed for a single dose only.
Utilize an aseptic technique to make ENJAYMO according to:
- To prevent foaming, don’t shake ENJAYMO.
- The parenteral drug product should be checked visually for any particulate matter or discoloration prior to administration, in the event that container and solution allow.
- ENJAYMO solution is clear to slightly opaque and colorless to a little yellow solution. Do not use if it is the color is discolored or if foreign material is detected.
- Take the volume you calculated from ENJAYMO from the proper quantity of vials, based on the dosage recommended (see TABLE ). Reduce the volume of ENJAYMO by 0.9 percent Sodium Chloride Injection USP for a total quantity of 500mL.
- See Table for the rate of infusion. Infuse the patient for 1 to 2 hours, based on the weight of the patient. The patient should be administered ENJAYMO infusion solution through an 0.2 millimeter inline filter using the membrane called polyethersulfone (PES) membrane.
- Prepare the tubing for infusion by using the dosing solution right prior to infusion. Then flush it immediately after the conclusion of the infusion using enough quantity (approximately 20 milliliters) of 0.9 percent Sodium Chloride Injection USP.
- When the ENJAYMO infusion solution isn’t used right away, store it in a refrigerator at 36degF-46degF (2degC up to 8degC).
- After being removed from the refrigerator After removal from refrigeration, let to allow the ENJAYMO the infusion mixture to warm up to room temperature, ranging from 68degF or 77degF (20degC up to 25degC), and then administer it after 8 hours. The total time from the point of preparation, including refrigerating and adjustments to room temperature, and the anticipated time of infusion should not be more than 36 hours. In-line infusion heaters can be utilized, but do not exceed temperatures of the temperature of 104degrees Fahrenheit (40degC).
- No incompatibilities have been observed between ENJAYMO infusion solution and infusion bags made of Di-(2-ethylhexyl)phthalate (DEHP) plasticized polyvinyl chloride (PVC), Ethyl Vinyl Acetate (EVA), and polyolefin (PO); administration sets made of DEHP-plasticized PVC, DEHP-free polypropylene (PP) and polyethylene (PE); and vial adapters made of polycarbonate (PC) and acrylonitrile-butadiene-styrene (ABS).
Table: Infusion Reference
|Body Weight Range||Dose||Number of ENJAYMO Vials Needed||ENJAYMO Volume||Volume of NaCl Diluent||Total Volume||Maximum Infusion Rate|
|39 kg to less than 70 kg||6,500 mg||6||130 mL||370 mL||500 mL||250 mL/hour|
|70 kg to less than 75 kg||6,500 mg||6||130 mL||370 mL||500 mL||500 mL/hour*|
|75 kg or greater||7,500 mg||7||150 mL||350 mL||500 mL||500 mL/hour*|
Reduce or stop the infusion in the event of reaction to infusions after ENJAYMO administration. Keep the patient in check for a minimum of two hours following the completion of the infusion to look for signs or signs of an infusion reaction and/or hypersensitivity reaction. Keep an eye on the patient for one hour following the completion of any subsequent infusions for any signs or symptoms that indicate a reaction to the infusion.
Enjaymo side effects
Enjaymo may cause serious side effects, which include:
- Check out for important information.
- Infusion-related reactions. Treatment with Enjaymo 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:
- rapid heartbeat
- The risk of developing an autoimmune disease. Enjaymo 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
- 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.
Inform the patient to read the FDA-approved labeling for patients (Medication Guidance).
- 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 ENJAYMO. Instruct patients about the signs of infections and urge that they seek immediate medical attention should any new signs of infection develop
- Inform patients that the administration of ENJAYMO 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 ENJAYMO 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 ENJAYMO is stopped. Also, they must be closely followed by their physician in the aftermath of ENJAYMO cessation
- Rx only
- Injection 1,100 mg/22 mL (50 mg/mL)
- For Intravenous Infusion After Dilution
- One single-dose vial
Discard unused portion
Always consult your physician to make sure the information presented on this site is appropriate to your particular situation.