Enjaymo (sutimlimab-jome)
An approved treatment for Cold Agglutinin Disease.
The same compound appears under different names depending on the context. Here is how to identify Sutimlimab-jome wherever you encounter it, plus the key facts at a glance.
- Generic name
- Sutimlimab-jome
- Brand name
- Enjaymo
- Development code
- BIVV009
- Drug class
- Classical complement inhibitor (anti-C1s monoclonal antibody)
- Manufacturer
- Recordati Rare Diseases (acquired from Sanofi in November 2024)
- How it's taken
- Given by a healthcare provider as an IV infusion, with the dose based on body weight: 6,500 mg for people weighing 39 kg to under 75 kg, and 7,500 mg for 75 kg or more.
An antibody given by IV infusion every 2 weeks, after 2 weekly starting doses, for adults with cold agglutinin disease (CAD). The FDA first approved it on February 4, 2022 to reduce the need for red blood cell transfusions caused by hemolysis (red blood cell destruction) in CAD, and on January 25, 2023 broadened the approval to the treatment of hemolysis in adults with CAD. Recordati Rare Diseases bought the global rights from Sanofi in November 2024 and now holds the US license.
Where Sutimlimab-jome fits
Recordati describes Enjaymo as the first and only FDA-approved treatment for hemolysis in adults with cold agglutinin disease[#enjaymo-patient-solutions]. Its approval rested on a placebo-controlled trial and a single-arm trial, not on comparisons with rituximab or other immunosuppressive treatments[#enjaymo-label].
How Sutimlimab-jome works
In CAD, antibodies called cold agglutinins attach to red blood cells and switch on the classical complement pathway, a part of the immune system that tags cells for destruction. The first protein in that pathway is C1, and its C1s portion passes the signal along by cutting the next protein, C4. Sutimlimab binds C1s and blocks it, so complement tags (called opsonins) stop building up on red blood cells and far fewer of them are destroyed. It leaves the other 2 complement pathways, the lectin and alternative pathways, working. It does not target the cold agglutinin antibodies themselves, and the label warns that hemolysis can return after treatment stops[1].
Mechanism: Humanized IgG4 monoclonal antibody that binds complement protein C1s and blocks the classical complement pathway, so complement no longer tags red blood cells for destruction
Side effects and safety
- Serious infections. Serious bacterial and viral infections occurred in 15% of trial patients, and 1 died. Vaccinate against pneumococcus and meningococcus at least 2 weeks before the first dose and stay up to date. Get care right away for fever with chills, rash, chest pain, fast breathing or a stiff neck, or for confusion.
- Infusion-related reactions. Occurred in 29% of trial patients, with symptoms such as shortness of breath, fast heartbeat, nausea, flushing, headache, low blood pressure, itching and rash. The infusion can be slowed or stopped.
- Risk of autoimmune disease. May raise the risk of autoimmune diseases such as lupus (SLE). Report joint pain or swelling, a rash on the cheeks and nose, or unexplained fever.
- Hemolysis returning after stopping. If treatment is interrupted, doctors watch for falling hemoglobin, rising bilirubin or LDH, fatigue, shortness of breath or dark urine, and may restart Enjaymo.
- Pneumococcal and meningococcal vaccines completed or updated before the first dose, with revaccination during treatment per ACIP guidance
- Observation for infusion reactions for at least 2 hours after the first infusion and 1 hour after later infusions
- Watch for signs of infection throughout treatment
- Hemoglobin, bilirubin and LDH if treatment is stopped or interrupted
Enjaymo has no boxed warning. It must not be given to people with a known allergy to sutimlimab-jome or its inactive ingredients. Because it blocks part of the immune system, it raises the risk of serious infections, including those caused by encapsulated bacteria such as Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae type B. In the 2 main trials, 15% of patients (10 of 66) had a serious infection and 1 died of Klebsiella pneumonia. Vaccines against pneumococcus and meningococcus (serogroups A, C, W, Y and B) should be completed or updated at least 2 weeks before the first dose unless treatment is urgent. Infusion-related reactions occurred in 29% (19 of 66). Blocking the classical pathway may raise the risk of autoimmune disease such as lupus, and 4.5% (3 of 66) had a relapse or worsening of an existing autoimmune disease. In the placebo-controlled CADENZA trial, the most common side effects on Enjaymo against placebo were headache (23% against 10%), high blood pressure (23% against 0%), runny nose (18% against 0%), bluish fingers and toes called acrocyanosis (18% against 0%) and Raynaud's phenomenon (18% against 0%). In the CARDINAL trial, which had no placebo group, urinary tract infection (38%), fatigue (33%) and dizziness (29%) were among the most common. If treatment stops, hemolysis can come back[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Sutimlimab-jome
Given by a healthcare provider as an IV infusion, with the dose based on body weight: 6,500 mg for people weighing 39 kg to under 75 kg, and 7,500 mg for 75 kg or more. Doses are given weekly for the first 2 weeks, then every 2 weeks, each within 2 days of schedule. An undiluted infusion takes about 1 hour and a diluted one 1 to 2 hours, and people with heart or lung disease may receive it over 2 hours. A missed dose is given as soon as possible; if more than 17 days pass after the last dose, the 2 weekly starting doses are repeated. Pneumococcal and meningococcal vaccines should be given at least 2 weeks before the first dose[1].
Availability and cost
Only available as the brand-name product.
Help paying for Enjaymo
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
RRD ENJAYMO Copay Assistance Program: may help eligible patients with commercial health insurance with out-of-pocket costs such as copayments or coinsurance. Not valid for prescriptions covered by Medicare, Medicaid, VA, DoD, TRICARE or similar federal or state programs. The page does not state a dollar amount or annual maximum; program details are given at registration.
For: private insurance · source - Free medicine program
RRD ENJAYMO Patient Assistance Program: supports eligible patients who have limited access to Enjaymo because of insurance issues or other financial challenges. The page does not publish income limits.
For: no insurance, underinsured · source - Other support
ENJAYMO No Cost Trial Program: a 30-day supply at no cost for eligible adults using Enjaymo for the first time for its approved use, regardless of insurance coverage. Once per lifetime. Requires enrollment in RRD Patient Solutions, and shipment depends on completing recommended vaccinations and scheduling the first infusion. For residents of the US, Puerto Rico or US territories treated by a US provider. After the trial, usual insurance costs apply.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source - Insurance and case manager help
Case Managers help patients get started and handle insurance-related needs throughout treatment, and Therapeutic Education Managers provide education about Enjaymo and cold agglutinin disease. Call Monday to Friday, 8 AM to 8 PM ET.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source
Good to know: Recordati completed its purchase of Enjaymo from Sanofi in November 2024, and the current US label lists Recordati Rare Diseases. The support page does not give a copay dollar amount, annual cap or income limits; call 1-833-223-2428 for details.
- From a charity · The Assistance FundCold Agglutinin Disease (CAD) fundWaitlist
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “WAITLIST — Accepting Waitlist Patients. TAF is currently accepting requests to join the enrollment waitlist for this program. Waitlists a…”
Access and eligibility
Approved for adults with cold agglutinin disease. Safety and effectiveness in children have not been established, and dosing starts at a body weight of 39 kg. The trials required a confirmed CAD diagnosis, including chronic hemolysis, a positive direct antiglobulin (Coombs) test for C3d and a cold agglutinin titer of at least 64. They excluded CAD caused by infection, rheumatologic disease, lupus or an overt blood cancer, but allowed people with low-grade lymphoproliferative disease.
Source: Recordati Rare Diseases Patient Solutions for Enjaymo
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
CARDINAL (NCT03347396) was a 26-week trial with no comparison group in 24 adults with CAD who had needed a blood transfusion in the prior 6 months. Its main goal, a hemoglobin rise of at least 2 g/dL or a level of at least 12 g/dL with no transfusions from week 5 to week 26 and no other CAD treatment, was met by 54% (13 of 24); 71% avoided transfusion over that time, and hemoglobin rose by an average of 3.18 g/dL[1][7]. CADENZA (NCT03347422) randomized 42 adults with CAD and no recent transfusion to Enjaymo or placebo for 26 weeks. Its main goal, a hemoglobin rise of at least 1.5 g/dL without transfusion or other CAD treatment, was met by 73% (16 of 22) on Enjaymo against 15% (3 of 20) on placebo. Hemoglobin rose 2.66 g/dL against 0.09 g/dL, and fatigue scores (FACIT-Fatigue) improved by 10.8 points against 1.9 points[1][8][10]. In both trials, hemoglobin fell and bilirubin rose again by 9 weeks after the last dose[1].
Development history
Sutimlimab was developed under the code BIVV009 by Bioverativ, a Sanofi company[9]. The FDA issued a complete response letter in November 2020, then approved Enjaymo on February 4, 2022 to decrease the need for red blood cell transfusions due to hemolysis in adults with CAD, based on CARDINAL[2][3]. On January 25, 2023, after adding CADENZA results to the label, the FDA approved a new indication statement: treatment of hemolysis in adults with CAD[4]. Recordati agreed on October 4, 2024 to buy the global rights to Enjaymo from Sanofi for $825 million upfront, plus up to $250 million in sales milestones, and announced it had completed the purchase on November 29, 2024[5][6]. Recordati Rare Diseases now holds the US license[1].
Explore Cold Agglutinin Disease trials
Common questions about Sutimlimab-jome
▸What is Sutimlimab-jome (Enjaymo)?
An antibody given by IV infusion every 2 weeks, after 2 weekly starting doses, for adults with cold agglutinin disease (CAD). The FDA first approved it on February 4, 2022 to reduce the need for red blood cell transfusions caused by hemolysis (red blood cell destruction) in CAD, and on January 25, 2023 broadened the approval to the treatment of hemolysis in adults with CAD. Recordati Rare Diseases bought the global rights from Sanofi in November 2024 and now holds the US license.
▸How does Sutimlimab-jome work?
In CAD, antibodies called cold agglutinins attach to red blood cells and switch on the classical complement pathway, a part of the immune system that tags cells for destruction. The first protein in that pathway is C1, and its C1s portion passes the signal along by cutting the next protein, C4. Sutimlimab binds C1s and blocks it, so complement tags (called opsonins) stop building up on red blood cells and far fewer of them are destroyed. It leaves the other 2 complement pathways, the lectin and alternative pathways, working. It does not target the cold agglutinin antibodies themselves, and the label warns that hemolysis can return after treatment stops[1].
▸What are the side effects of Sutimlimab-jome?
Enjaymo has no boxed warning. It must not be given to people with a known allergy to sutimlimab-jome or its inactive ingredients. Because it blocks part of the immune system, it raises the risk of serious infections, including those caused by encapsulated bacteria such as Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae type B. In the 2 main trials, 15% of patients (10 of 66) had a serious infection and 1 died of Klebsiella pneumonia. Vaccines against pneumococcus and meningococcus (serogroups A, C, W, Y and B) should be completed or updated at least 2 weeks before the first dose unless treatment is urgent. Infusion-related reactions occurred in 29% (19 of 66). Blocking the classical pathway may raise the risk of autoimmune disease such as lupus, and 4.5% (3 of 66) had a relapse or worsening of an existing autoimmune disease. In the placebo-controlled CADENZA trial, the most common side effects on Enjaymo against placebo were headache (23% against 10%), high blood pressure (23% against 0%), runny nose (18% against 0%), bluish fingers and toes called acrocyanosis (18% against 0%) and Raynaud's phenomenon (18% against 0%). In the CARDINAL trial, which had no placebo group, urinary tract infection (38%), fatigue (33%) and dizziness (29%) were among the most common. If treatment stops, hemolysis can come back[1].
▸How is Sutimlimab-jome taken?
Given by a healthcare provider as an IV infusion, with the dose based on body weight: 6,500 mg for people weighing 39 kg to under 75 kg, and 7,500 mg for 75 kg or more. Doses are given weekly for the first 2 weeks, then every 2 weeks, each within 2 days of schedule. An undiluted infusion takes about 1 hour and a diluted one 1 to 2 hours, and people with heart or lung disease may receive it over 2 hours. A missed dose is given as soon as possible; if more than 17 days pass after the last dose, the 2 weekly starting doses are repeated. Pneumococcal and meningococcal vaccines should be given at least 2 weeks before the first dose[1].
▸Is Sutimlimab-jome FDA approved?
Yes, Sutimlimab-jome (Enjaymo) is FDA approved (2022) for the treatment of Cold Agglutinin Disease.
▸Who makes Enjaymo now?
Recordati Rare Diseases. The original 2022 approval went to Bioverativ, part of Sanofi, and Recordati announced on November 29, 2024 that it had completed buying the global rights from Sanofi. The current US label lists Recordati Rare Diseases, and its patient support program, RRD Patient Solutions, can be reached at 1-833-223-2428.
▸Do I need vaccines before starting Enjaymo?
Yes. The label calls for pneumococcal and meningococcal vaccines (meningococcal serogroups A, C, W, Y and B) to be completed or updated at least 2 weeks before the first dose, unless treatment is urgent, with revaccination during treatment following ACIP guidance. Vaccines lower but do not remove the risk of serious infection, so fever or other signs of infection need prompt care.
▸What happens if you stop Enjaymo?
Hemolysis can come back. In both main trials, hemoglobin dropped by about 2.3 to 2.4 g/dL and bilirubin rose by about 9 weeks after the last dose. The label advises close monitoring for signs of hemolysis if treatment is interrupted and says restarting Enjaymo can be considered.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed · 2026-03. ENJAYMO (sutimlimab-jome) injection, for intravenous use: prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0a25363a-7781-d9f8-cb1c-be22987bf03b
- U.S. Food and Drug Administration · 2022-02-04. BLA 761164 approval letter. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761164Orig1s000ltr.pdf
- U.S. Food and Drug Administration · 2022-02-04. ENJAYMO prescribing information as approved February 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761164s000lbl.pdf
- U.S. Food and Drug Administration · 2023-01-25. BLA 761164/S-003 supplement approval (new indication statement). https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761164Orig1s003ltr.pdf
- Recordati · 2024-10-04. Recordati announces agreement to acquire the global rights to Enjaymo, strengthening its rare diseases franchise. https://recordati.com/wp-content/uploads/2024/10/PR_Acquisition-of-global-rights-to-Enjaymo.pdf
- Recordati · 2024-11-29. Recordati completes the acquisition of the global rights to Enjaymo. https://recordati.com/recordati-completes-the-acquisition-of-the-global-rights-to-enjaymo/
- New England Journal of Medicine · 2021. Sutimlimab in Cold Agglutinin Disease. https://www.nejm.org/doi/full/10.1056/NEJMoa2027760
- Blood · 2022. Sutimlimab in patients with cold agglutinin disease: results of the randomized placebo-controlled phase 3 CADENZA trial. https://doi.org/10.1182/blood.2021014955
- ClinicalTrials.gov. A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study). https://clinicaltrials.gov/study/NCT03347396
- ClinicalTrials.gov. A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion (Cadenza). https://clinicaltrials.gov/study/NCT03347422
- Recordati Rare Diseases. Patient Solutions: Recordati Rare Diseases Patient Solutions for ENJAYMO. https://enjaymo.com/patient-solutions/