Version July 2025
Dosage guidance:
Safety: Vaccinate patients against encapsulated bacteria, including Streptococcus pneumoniae and Neisseria meningitidis (serogroups A, C, W, Y, and B), at least 2 weeks prior to sutimlimab initiation, according to current recommendations from the Advisory Committee on Immunization Practices. If urgent sutimlimab treatment is indicated in a patient who is not up to date with vaccines for S. pneumoniae or N. meningitidis, administer vaccines as soon as possible.
Cold agglutinin disease: Note: Administer sutimlimab at the recommended dosage regimen time points, or within 2 days of these time points.
39 kg to <75 kg: IV: 6.5 g once weekly for 2 weeks (on days 0 and 7), followed with 6.5 g once every 2 weeks thereafter, beginning on day 21 (Ref).
≥75 kg: IV: 7.5 g once weekly for 2 weeks (on days 0 and 7), followed with 7.5 g once every 2 weeks thereafter, beginning on day 21 (Ref).
Discontinuation of therapy: If sutimlimab treatment is interrupted, closely monitor patients for signs/symptoms of recurrent hemolysis, such as elevated total bilirubin levels or lactate dehydrogenase levels accompanied by a decrease in hemoglobin, or reappearance of symptoms such as fatigue, dyspnea, palpitations, or hemoglobinuria. Consider restarting sutimlimab if signs/symptoms of hemolysis occur after discontinuation.
Missed doses: If a sutimlimab dose is missed, administer as soon as possible; thereafter, resume dosing every 2 weeks. If the duration after the last dose exceeds 17 days, administer sutimlimab once weekly for 2 weeks, and return to every 2 weeks thereafter.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
eGFR ≥30 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer’s labeling; however, no clinically significant differences on sutimlimab pharmacokinetics were observed in mild or moderate impairment.
eGFR <30 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer’s labeling (effects are unknown).
There are no dosage adjustments provided in the manufacturer’s labeling (effects are unknown).
Autoimmune disease: Manage as medically appropriate.
Hypersensitivity: Discontinue sutimlimab infusion and institute appropriate supportive management if signs of hypersensitivity reactions (eg, cardiovascular instability or respiratory compromise) occur.
Infusion reaction: Slow or stop the infusion.
Infection, serious: Consider sutimlimab treatment interruption in patients who are being treated for serious infection.
Refer to adult dosing.
Infections (eg, bacterial infection, otomastoiditis, pneumonia, skin infection, urinary tract infection, viral infection), including serious infections (eg, sepsis), have been reported. Sutimlimab may increase susceptibility to infections caused by encapsulated bacteria (eg, Haemophilus influenzae, Neisseria meningitidis, Streptococcus pneumoniae) and may worsen preexisting active systemic infections.
Mechanism: Dose-related; related to the pharmacologic action of sutimlimab.
Risk factors:
• Unvaccinated against encapsulated bacteria
Infusion-related reactions, including flushing, headache, nausea, rapid heartbeat, sensation of cold, shortness of breath, and stress cardiomyopathy, have been reported with sutimlimab. In clinical trials, all reactions were described as mild or moderate in severity and resolved within a day (Ref). Infusion rate reduction, therapy interruption, and/or discontinuation may be required.
Onset: Rapid (Ref); within 24 hours of initiation of infusion.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Cardiovascular: Hypertension, peripheral edema, Raynaud disease
Gastrointestinal: Abdominal pain, nausea
Genitourinary: Urinary tract infection (including urinary tract infection with sepsis)
Hypersensitivity: Infusion-related reaction
Infection: Infection (including bacterial infection and viral infection), serious infection (including otitis media [otomastoiditis], pneumonia, sepsis, and skin infection)
Nervous system: Dizziness, fatigue (including asthenia and malaise), headache
Neuromuscular & skeletal: Arthralgia
Respiratory: Cough, cyanosis (acrocyanosis), nasopharyngitis, respiratory tract infection, rhinitis
Miscellaneous: Fever
1% to 10%: Immunologic: Autoimmune disease (relapse or worsening)
Frequency not defined: Renal: Increased serum creatinine
Known hypersensitivity to sutimlimab or any component of the formulation.
Concerns related to adverse effects:
• Autoimmune disease: Based on the mechanism of action, sutimlimab has the potential to increase the risk for development of autoimmune diseases (eg, systemic lupus erythematosus [SLE]). The development of SLE has been associated with inherited classical complement deficiency. Patients with SLE or autoimmune disease with positive antinuclear antibody were excluded from sutimlimab clinical trials. A small percentage of patients experienced a relapse or worsening of preexisting autoimmune disease in clinical trials.
Disease-related concerns:
• Systemic infections: If not recognized and treated promptly, some infections could rapidly become life-threatening or fatal. The patient's immune status should be taken into consideration when initiating sutimlimab treatment. Sutimlimab has not been studied in patients with chronic systemic infections such as hepatitis B, hepatitis C, or HIV.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Enjaymo: Sutimlimab-jome 1100 mg/22 mL (22 mL) [contains polysorbate 80]
No
Solution (Enjaymo Intravenous)
1100MG/22ML (per mL): $107.73
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Available through specialty distributors. Information regarding distribution is available from the manufacturer at https://www.enjaymohcp.com/resources-for-your-practice.
IV: Infuse over 1 to 2 hours (depending on patient weight; see tables). Administer via a 0.2 micron in-line filter with a polyethersulfone membrane. Prime the infusion tubing with the dosing solution immediately before infusion (if infusing undiluted, also prime infusion catheter); flush with a sufficient quantity of NS (~20 mL) immediately after completion of infusion.
|
Body weight |
Sutimlimab dose |
Sutimlimab volume |
Maximum infusion rate |
|---|---|---|---|
|
a May infuse over 120 minutes in patients with cardiopulmonary disease. | |||
|
39 kg to <75 kg |
6.5 g |
130 ml |
130 mL/houra |
|
≥75 kg |
7.5 g |
150 mL |
150 mL/houra |
|
Body weight |
Sutimlimab dose |
Total volume |
Maximum infusion rate |
|---|---|---|---|
|
a May infuse over 120 minutes in patients with cardiopulmonary disease. | |||
|
39 kg to <70 kg |
6.5 g |
500 mL |
250 mL/hour |
|
70 kg to <75 kg |
6.5 g |
500 mL |
500 mL/houra |
|
≥75 kg |
7.5 g |
500 mL |
500 mL/houra |
If refrigerated, allow the infusion solution (diluted or undiluted) to adjust to room temperature and administer within 8 hours. In-line infusion warmers may be utilized; do not exceed a temperature of 40°C (104°F). No incompatibilities have been observed between sutimlimab infusion solution and administration sets made of DEHP-plasticized PVC, DEHP-free polypropylene and polyethylene.
If an infusion reaction occurs, slow or stop the infusion. Monitor during infusion and for at least 2 hours after the initial infusion for signs/symptoms of infusion and/or hypersensitivity reaction; monitor for 1 hour after subsequent infusions for signs/symptoms of infusion reaction.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Enjaymo: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761164s000lbl.pdf
Cold agglutinin disease: Treatment of hemolysis in adults with cold agglutinin disease.
Enjaymo may be confused with Entyvio.
Sutimlimab may be confused with sarilumab, siltuximab.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid
Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Therapeutic Immunosuppressant Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification
Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider Therapy Modification
Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification
Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Pimecrolimus. Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification
Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification
Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor
Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid
Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid
Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Sutimlimab is a humanized monoclonal antibody (IgG4). Human IgG crosses the placenta. Exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
It is not known if sutimlimab is present in breast milk.
Sutimlimab is a humanized monoclonal antibody (IgG4). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Monitor for signs/symptoms of infection; if sutimlimab is administered to patients with active systemic infections, monitor closely for worsening infection. Monitor for signs/symptoms of infusion and/or hypersensitivity reaction during infusion and for at least 2 hours after the initial infusion; monitor for 1 hour after subsequent infusions. Monitor for signs/symptoms of autoimmune disease. Upon treatment interruption or discontinuation, monitor for signs/symptoms of recurrent hemolysis (eg, elevated total bilirubin levels or lactate dehydrogenase [LDH] levels accompanied by a decrease in hemoglobin, or reappearance of symptoms such as fatigue, dyspnea, palpitations, or hemoglobinuria).
Sutimlimab is a humanized immunoglobulin G (IgG4) monoclonal antibody which targets and inhibits complement (Röth 2021). Sutimlimab inhibits the classical complement pathway by specifically binding to the complement protein component 1, s subcomponent (C1s), which is a serine protease that cleaves C4. Inhibition of the classical complement pathway at the C1s level prevents deposition of complement opsonins on RBC surfaces, resulting in inhibition of hemolysis in cold agglutinin disease. Sutimlimab does not inhibit the lectin and alternative pathways.
Onset: Mean hemoglobin level increased by 1.2 g/dL within the first week and by ~2.3 g/dL by the third week (Röth 2021).
Distribution: Vdss: ~5.8 L.
Metabolism: Via degradation into small peptides and individual amino acids.
Half-life elimination: 21 days.
Excretion: Clearance: ~0.14 L/day.
Body weight: Population pharmacokinetic analysis demonstrated that sutimlimab AUC at steady state decreased up to 40% for a patient weighing 110 kg following the 7.5 g dose and increased up to 170% for a patient weighing 40 kg following the 6.5 g dose, when compared to a patient weighing 70 kg following the 6.5 g dose. Sutimlimab is dosed by weight ranges to accommodate for the effect of body weight on pharmacokinetics.
