Enjaymo

Generic Name: sutimlimab-jome

Dosage Form: injection, for intravenous use

Medically reviewed by A Rash MD. Updated on March 23, 2022.

What is  Enjaymo?

EnjaymoEnjaymo 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
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

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.

Warnings and precautions

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:

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?

Dosage and administration

Recommended vaccinations

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:

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 ENJAYMO. 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 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 

Discontinuation

  • 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 

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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