Sutimlimab-Jome: uses, dosing, side effects & brands
Sutimlimab-Jome is a medicine sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Available as
- Injectable
- Sold as
- Enjaymo
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How sutimlimab-jome is dosed
From the FDA label for Enjaymo (application BLA761164). Other sutimlimab-jome products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Vaccinate against encapsulated bacteria at least two weeks prior to treatment. ( 2.1 ) Weight-based dosage weekly for two weeks then every two weeks: For patients weighing 39 kg to less than 75 kg: 6,500 mg by intravenous infusion. ( 2.2 ) For patients weighing 75 kg or more: 7,500 mg by intravenous infusion. ( 2.2 ) See Full Prescribing Information for important preparation and administration instructions. ( 2.2 , 2.3 ) 2.1 Recommended Vaccinations for Encapsulated Bacterial Infections Vaccinate patients against encapsulated bacteria, including Streptococcus pneumoniae and Neisseria meningitidis (serogroups A, C, W, Y and B), according to current Advisory Committee on Immunization Practices (ACIP) recommendations at least 2 weeks prior to initiation of ENJAYMO [see Warnings and Precautions (5.1) ]. If urgent ENJAYMO therapy is indicated in a patient who is not up to date with vaccines for Streptococcus pneumoniae and Neisseria meningitidis administer these vaccines as soon as possible. 2.2 Recommended Dosage Regimen The recommended dosage of ENJAYMO for patients with CAD is based on body weight. For patients weighing 39 kg to less than 75 kg, the recommended dose is 6,500 mg and for patients weighing 75 kg or more, the recommended dose is 7,500 mg. Administer ENJAYMO intravenously weekly for the first two weeks, with administration every two weeks thereafter. Administer…
Sutimlimab-Jome side effects
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Serious Infections [see Warnings and Precautions (5.1) ] Infusion-Related Reactions [see Warnings and Precautions (5.2) ] Risk of Autoimmune Disease [see Warnings and Precautions (5.3) ] Recurrent Hemolysis After ENJAYMO Discontinuation [see Warnings and Precautions (5.4) ] Most common adverse reactions in the CADENZA study (Part A) (incidence ≥18%) are rhinitis, headache, hypertension, acrocyanosis, and Raynaud's phenomenon. The most common adverse reactions in the CARDINAL study (incidence ≥25%) are urinary tract infection, respiratory tract infection, bacterial infection, dizziness, fatigue, peripheral edema, arthralgia, cough, hypertension, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ENJAYMO in patients with a confirmed diagnosis of CAD was evaluated in a placebo-controlled study (CADENZA) in Part A (n=42) followed by an open-label…
Who shouldn’t take sutimlimab-jome
ENJAYMO is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] . ENJAYMO is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients. ( 4 )
Every sutimlimab-jome product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Enjaymo.
What people report to the FDA about sutimlimab-jome
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 30 reports naming sutimlimab-jome, and the FDA flagged 53% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- haemoglobin decreased5 reports
- acute hepatic failure4 reports
- disseminated varicella zoster virus infection4 reports
- hepatic necrosis4 reports
- hepatitis viral4 reports
- infection reactivation4 reports
- fatigue3 reports
- urinary tract infection3 reports
Read these as a signal, not a rate. A report does not mean sutimlimab-jome caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 26, 2026.
Related calculators
Frequently asked questions
What is sutimlimab-jome?
Enjaymo (Sutimlimab-Jome) is a medication supplied as an injection, solution, concentrate.
Can you take sutimlimab-jome with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run sutimlimab-jome against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does sutimlimab-jome come in?
Across the brands we track, sutimlimab-jome is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic sutimlimab-jome?
We do not currently list a generic-labelled sutimlimab-jome product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Sutimlimab-Jome: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/sutimlimab-jome
- MLA
- “Sutimlimab-Jome: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/sutimlimab-jome.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for sutimlimab-jome on DailyMed (NIH) ↗.