Note: Vaccinate patients against encapsulated bacteria at least 2 weeks prior to sutimlimab initiation, according to the most current recommendations from the Advisory Committee on Immunization Practices for patients with persistent complement deficiencies, and revaccinate patients in accordance with those recommendations. Immunize patients without a history of vaccination against encapsulated bacteria at least 2 weeks prior to receiving the first sutimlimab dose; if urgent treatment with sutimlimab is indicated in an unvaccinated patient, administer vaccine(s) 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 (Röth 2021).
≥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 (Röth 2021).
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 (has not been studied).
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Refer to adult dosing.
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.
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
Available through specialty distributors. Information regarding distribution is available from the manufacturer at https://www.enjaymohcp.com/resources-for-your-practice.
An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761164s000lbl.pdf#page=13, must be dispensed with this medication.
IV: Infuse over 1 to 2 hours (depending on the patient’s body weight; see table). Administer via a 0.2 micron in-line filter with a polyethersulfone membrane. Prime the infusion tubing with the dosing solution immediately before infusion; flush with a sufficient quantity of NS (~20 mL) immediately after completion of infusion.
|
Body weight |
Sutimlimab dose |
Total volume |
Maximum infusion rate |
|---|---|---|---|
|
a Infuse over 120 minutes in patients with cardiopulmonary disease. | |||
|
39 kg to <70 kg |
6,500 mg |
500 mL |
250 mL/hour |
|
70 kg to <75 kg |
6,500 mg |
500 mL |
500 mL/houra |
|
≥75 kg |
7,500 mg |
500 mL |
500 mL/houra |
If refrigerated, allow the infusion solution 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.
Cold agglutinin disease: To decrease the need for red blood cell transfusion due to hemolysis in adults with cold agglutinin disease.
Enjaymo may be confused with Entyvio.
Sutimlimab may be confused with sarilumab, siltuximab.
Infections (eg, bacterial infection, gastroenteritis, respiratory tract infection, 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, and shortness of breath, 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)
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Cardiovascular: Peripheral edema (13%)
Dermatologic: Skin infection (serious: ≤17%)
Gastrointestinal: Diarrhea (13%), dyspepsia (13%)
Infection: Serious infection (≤17%, including sepsis), viral infection (13%)
Neuromuscular & skeletal: Arthralgia (≤13%), arthritis (≤13%)
Respiratory: Cough (13%), respiratory tract infection (25%)
1% to 10%:
Cardiovascular: Hypertension (8%)
Gastrointestinal: Abdominal pain (8%), gastroenteritis (8%)
Genitourinary: Urinary tract infection (8%)
Hypersensitivity: Infusion-related reaction (8%)
Infection: Bacterial infection (8%)
Nervous system: Fatigue (8%), headache (8%)
Respiratory: Cyanosis (8%)
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.
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.
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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
Coccidioides immitis Skin Test: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. 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
COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy
Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect 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 enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect 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
Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Pimecrolimus. Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the potential for allergic or hypersensitivity reactions to 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
Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect 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 Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect 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 combination
Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect 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 combination
Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
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 exposures decreased up to 59% for a patient weighing 98 kg and increased up to 57% for a patient weighing ~51 kg, when compared to a patient weighing 72 kg. Sutimlimab is dosed by weight ranges to accommodate for the effect of body weight on pharmacokinetics.
Solution (Enjaymo Intravenous)
1100MG/22ML (per mL): $98.18
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