Sutimlimab-jome Injection
Sutimlimab-jome is a targeted injectable medicine used to treat hemolysis (the breakdown of red blood cells) in adults with cold agglutinin disease.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Sutimlimab-jome Injection: Patient Information Guide
A plain-language walkthrough of Sutimlimab-jome Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
What Sutimlimab-jome Injection is used for
▾
Sutimlimab-jome injection is approved for one specific use in adults:
- Enjaymo (sutimlimab-jome), given by intravenous infusion, is indicated for the treatment of hemolysis — the immune-mediated breakdown of red blood cells — in adults with cold agglutinin disease (CAD).
How Sutimlimab-jome Injection works
▾
Sutimlimab-jome is a monoclonal antibody — a precision-engineered protein — that targets a specific enzyme called C1s in the immune system. C1s is an early activating step in what's called the classical complement pathway, a chain reaction that can lead to the destruction of red blood cells in people with cold agglutinin disease. By binding to and blocking C1s, Enjaymo stops this chain reaction before it gets started, preventing immune proteins from coating red blood cells and marking them for destruction. This allows more red blood cells to survive and circulate, improving anemia and related symptoms.
Importantly, sutimlimab-jome only blocks the classical complement pathway — it does not interfere with the lectin or alternative complement pathways, which means other parts of the immune system remain active.
How Sutimlimab-jome Injection is taken (dosage)
▾
Enjaymo is given by intravenous (IV) infusion at a clinic or infusion center — it cannot be taken by mouth or self-administered at home. The dose is determined by your body weight. It is given once a week for the first two weeks, then once every two weeks thereafter. Infusions are typically administered over about one hour.
- Vaccines against certain bacteria must be given at least 2 weeks before starting Enjaymo.
- If you miss a dose, contact your care team as soon as possible — do not wait until your next scheduled visit.
- If it has been more than 17 days since your last dose, your doctor will likely restart the weekly loading schedule before returning to every-two-weeks dosing.
Sutimlimab-jome Injection side effects in detail
▾
The most commonly reported side effects with Enjaymo include:
- Headache
- High blood pressure (hypertension)
- Runny or stuffy nose (rhinitis)
- Dizziness
- Fatigue or weakness
- Nausea
- Joint pain (arthralgia)
- Swelling in the legs or feet (peripheral edema)
- Cough
- Acrocyanosis (bluish discoloration of the skin, especially hands and feet) and Raynaud's phenomenon (reduced blood flow to fingers and toes)
- Infusion-related reactions such as shortness of breath, flushing, or chest discomfort
Serious reactions — including life-threatening infections, severe infusion reactions (trouble breathing, cardiovascular instability), and signs of returning hemolysis after stopping treatment — require immediate medical attention. Call your doctor or go to an emergency room right away if you experience these.
Sutimlimab-jome Injection warnings and precautions
▾
- Serious infections: Enjaymo suppresses part of the immune system and raises the risk of life-threatening infections caused by encapsulated bacteria such as Neisseria meningitidis (meningococcus), Streptococcus pneumoniae, and Haemophilus influenzae. Fatal infections have occurred. You must be vaccinated against these bacteria at least 2 weeks before starting treatment — but be aware that vaccination does not completely eliminate the risk.
- Infusion-related reactions: Nearly 1 in 3 patients experienced some form of reaction during infusion, including shortness of breath, rapid heartbeat, nausea, flushing, or dizziness. Your care team will monitor you closely. If a severe reaction occurs, the infusion will be stopped and treated immediately.
- Risk of autoimmune disease: Because Enjaymo blocks part of the complement immune system, it may increase the risk of autoimmune conditions like systemic lupus erythematosus (SLE, or lupus). Report any new or worsening symptoms to your doctor.
- Hemolysis returning after stopping treatment: If Enjaymo is discontinued, red blood cell destruction may come back. Your doctor will monitor you carefully and may restart treatment if needed.
Sutimlimab-jome Injection interactions: what it interacts with
▾
The FDA label for Enjaymo does not describe specific drug, food, or supplement interactions. However, because Enjaymo affects the immune system, always tell your doctor and pharmacist about every medication, supplement, and vaccine you are taking before starting treatment.
- Vaccines: Required vaccinations (meningococcal, pneumococcal, Haemophilus influenzae) must be given before starting Enjaymo — timing matters for safety.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
Before taking Sutimlimab-jome Injection
▾
- Allergy: Enjaymo is contraindicated if you have a known allergy to sutimlimab-jome or any of its inactive ingredients.
- Vaccines: You must be up to date on vaccines for encapsulated bacteria (meningococcus, pneumococcus, Haemophilus influenzae type B) at least 2 weeks before your first infusion.
- Active infections: Tell your doctor about any current infections; Enjaymo has not been studied in people with chronic systemic infections such as hepatitis B, hepatitis C, or HIV.
- Autoimmune disease: Tell your doctor if you have lupus (SLE) or other autoimmune conditions — these patients were excluded from clinical trials, and Enjaymo may worsen such conditions.
- Pregnancy: There are no adequate human data on Enjaymo use during pregnancy. As an antibody, it can cross the placenta and reach the developing fetus. Discuss the risks and benefits carefully with your doctor.
- Breastfeeding: It is unknown whether Enjaymo passes into breast milk or affects a nursing infant. Discuss with your doctor before breastfeeding while on this medication.
- Children: Enjaymo's safety and effectiveness have not been established in patients under 18.
- Older adults: Most patients in clinical trials were 65 or older, and no overall differences in safety or effectiveness were observed compared to younger patients — though individual sensitivity may vary.
- Kidney or liver problems: Mild to moderate kidney impairment did not significantly affect how Enjaymo works in the body, but the effects of severe kidney impairment or any degree of liver impairment are not known.
Pharmacodynamics: what Sutimlimab-jome Injection does in the body
▾
After a single infusion of Enjaymo, more than 90% inhibition of the classical complement pathway is achieved and sustained when drug levels remain at or above a certain threshold. Within one week of the first dose, key blood markers of red blood cell destruction — including bilirubin and LDH (lactate dehydrogenase) — begin to normalize, while hemoglobin levels rise. This reflects the drug's ability to stop the immune attack on red blood cells. The strength and duration of these effects are tied directly to the amount of drug in the body.
Pharmacokinetics: how your body processes Sutimlimab-jome Injection
▾
Enjaymo is given intravenously and binds to C1s protein in the blood. Steady-state drug levels are typically reached by Week 7 of treatment. The drug has a terminal half-life of about 21 days, meaning it takes roughly three weeks for half a dose to clear the body. Like other antibody-based medicines, sutimlimab-jome is broken down by the body into small peptides and amino acids — the normal building blocks of proteins. The dose is adjusted by body weight because heavier patients reach lower drug exposure at a given dose, and lighter patients reach higher exposure.
How to store Sutimlimab-jome Injection
▾
Store ENJAYMO vials refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do not freeze.
📄 Written from Sutimlimab-jome Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Sutimlimab-jome Injection
53 supplements and herbal products have documented interactions with Sutimlimab-jome Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Moderate · 52
- Minor · 1
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Sutimlimab-jome Injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Sutimlimab-jome Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is cold agglutinin disease and why do I need this medicine?
▾
How often will I need to come in for infusions?
▾
I heard I need vaccines before starting — which ones and why?
▾
What side effects should I expect, and which ones should make me call my doctor right away?
▾
What happens if I need to stop taking Enjaymo?
▾
Is it safe to take Enjaymo if I'm pregnant or breastfeeding?
▾
Is Sutimlimab-jome Injection available over the counter?
▾
When was Sutimlimab-jome Injection first available?
▾
Who makes Sutimlimab-jome Injection?
▾
💬 Answers drafted from Sutimlimab-jome Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 More about Sutimlimab-jome Injection on HelloPharmacist
💊 Sutimlimab-jome Injection forms and strengths (how it comes)
Sutimlimab-jome Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Enjaymo is used to treat hemolysis (red blood cell destruction) in adults with cold agglutinin disease (CAD)
- Enjaymo is administered by intravenous infusion only — given into a vein by a healthcare provider at a clinic or infusion center
- Enjaymo is given once weekly for the first two weeks, then once every two weeks; the dose is based on your body weight
- Enjaymo infusions are typically given over about one hour; patients with certain heart or lung conditions may receive it over a longer period
- You will be monitored for at least two hours after your first Enjaymo infusion, and for at least one hour after subsequent infusions, for any signs of a reaction
📊 Sutimlimab-jome Injection on the U.S. market: products, makers and brands
How Sutimlimab-jome Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Sutimlimab-jome Injection is used (Medicaid data)
A general measure of how commonly Sutimlimab-jome Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Sutimlimab-jome Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Sutimlimab-jome Injection prescribed? Of the 1,599 medications we measure, Sutimlimab-jome Injection ranks #1,595 by Medicaid prescriptions — more than 0% of them.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Sutimlimab-jome Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 2 listed Sutimlimab-jome Injection NDCs with Medicaid activity.
🔍 Compare Sutimlimab-jome Injection products
A representative set of FDA-listed product records for Sutimlimab-jome Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 50 mg/mL | Intravenous | Bioverativ Therapeutics Inc. | BLA | View NDC → |
| 50 mg/mL | Intravenous | Bioverativ U.S. LLC. | BLA | View NDC → |
| 50 mg/mL | Intravenous | Recordati Rare Diseases, Inc. | BLA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Sutimlimab-jome Injection NDCs →
📈 Sutimlimab-jome Injection side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Sutimlimab-jome Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Sutimlimab-jome Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ Sutimlimab-jome Injection FDA approval history
How Sutimlimab-jome Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Sutimlimab-jome Injection recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Sutimlimab-jome Injection supply and shortage status
Whether Sutimlimab-jome Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sutimlimab-jome Injection brand names
🏭 Who makes Sutimlimab-jome Injection: manufacturers and labelers
Sutimlimab-jome Injection drug class (RxNorm)
Sutimlimab-jome Injection belongs to the Classical Complement Pathway Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Sources for this Sutimlimab-jome Injection page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Recordati Rare Diseases, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.