Version July 2025
Patients treated with sarilumab are at increased risk for developing serious infections that may lead to hospitalization or death. Opportunistic infections have also been reported in patients receiving sarilumab. Most patients who developed infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Avoid use of sarilumab in patients with an active infection.
Reported infections include:
- Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before sarilumab use and during therapy. Treatment for latent infection should be initiated prior to sarilumab use.
- Invasive fungal infections, such as candidiasis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
- Bacterial, viral and other infections due to opportunistic pathogens.
Closely monitor patients for signs and symptoms of infection during treatment with sarilumab. If a serious infection develops, interrupt sarilumab until the infection is controlled.
Consider the risks and benefits of treatment with sarilumab prior to initiating therapy in patients with chronic or recurrent infection.
Note: Do not initiate if ANC is <2,000/mm3, platelets are <150,000/mm3, or if ALT or AST are >1.5 times ULN.
COVID-19, hospitalized patients (off-label use) (alternative agent): Note: Use as an alternative to IV tocilizumab for hospitalized patients with significant oxygen requirements (eg, high-flow oxygen, noninvasive ventilation, mechanical ventilation, extracorporeal membrane oxygenation) and for those with lower but increasing oxygen requirements and evidence of systemic inflammation (eg, C-reactive protein ≥75 mg/L) (Ref).
IV (off-label route): 400 mg once, as part of an appropriate combination regimen (Ref).
Polymyalgia rheumatica: Note: For use as adjunctive therapy with a tapering course of systemic corticosteroids or as monotherapy following discontinuation of corticosteroids.
SUBQ: 200 mg once every 2 weeks.
Rheumatoid arthritis: Note: For use as adjunctive therapy in patients who have not met treatment goals despite maximally tolerated methotrexate therapy; may also be used off label as an alternative to methotrexate in disease-modifying antirheumatic drug (DMARD)-naive patients with moderate to high disease activity (Ref). May be used in combination with nonbiologic DMARDs.
SUBQ: 200 mg once every 2 weeks.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
CrCl 30 to 90 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Hepatic impairment prior to treatment initiation: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Sarilumab is not recommended for use in patients with active hepatic disease or hepatic impairment.
Hepatotoxicity during treatment:
Polymyalgia rheumatica:
ALT or AST >3 × ULN: Discontinue sarilumab.
Rheumatoid arthritis:
ALT or AST >1 to ≤3 × ULN: Adjust concomitant DMARDs as appropriate.
ALT or AST >3 to ≤5 × ULN: Interrupt therapy; when ALT or AST is <3 × ULN, resume at 150 mg once every 2 weeks (may increase to 200 mg once every 2 weeks as clinically appropriate).
ALT or AST >5 × ULN: Discontinue sarilumab.
Hematologic toxicity:
Polymyalgia rheumatica:
ANC <1,000/mm3: Discontinue sarilumab.
Platelets <100,000/mm3: Discontinue sarilumab.
Rheumatoid arthritis:
ANC >1,000/mm3: No dosage adjustment necessary.
ANC 500 to 1,000/mm3: Interrupt therapy; when ANC >1,000/mm3, resume at 150 mg once every 2 weeks (may increase to 200 mg once every 2 weeks as clinically appropriate).
ANC <500/mm3: Discontinue sarilumab.
Platelets 50,000 to 100,000/mm3: Interrupt therapy; when platelet count is >100,000/mm3, resume at 150 mg once every 2 weeks (may increase to 200 mg once every 2 weeks as clinically appropriate).
Platelets <50,000/mm3: If confirmed by repeat testing, discontinue sarilumab.
Nonhematologic toxicity:
Hypersensitivity (anaphylaxis or other clinically significant hypersensitivity reaction): Stop immediately and discontinue sarilumab permanently.
Infection (serious or opportunistic): Interrupt treatment until the infection is controlled.
Refer to adult dosing.
(For additional information see "Sarilumab: Pediatric drug information")
Dosage guidance:
Dosage form information: Available dosage forms are only appropriate for patients weighing ≥63 kg. Only the prefilled syringe is approved for use in pediatric patients.
Clinical considerations: Treatment not recommended if ANC is <2,000/mm3, platelets are <150,000/mm3, if ALT or AST are >1.5 times ULN, or if patient has active infection.
Juvenile idiopathic arthritis, polyarticular: Children ≥2 years weighing ≥63 kg and Adolescents weighing ≥63 kg: SUBQ: 200 mg once every 2 weeks.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Dosing adjustment for toxicity:
Children ≥2 years weighing ≥63 kg and Adolescents weighing ≥63 kg: SUBQ:
Hypersensitivity (anaphylaxis or other clinically significant hypersensitivity reaction): Stop immediately and discontinue sarilumab permanently.
Infection (serious or opportunistic): Interrupt treatment until the infection is controlled.
Neutropenia:
ANC 500 to <1,000/mm3: Hold sarilumab; decision to restart therapy should be individualized.
ANC <500/mm3 associated with infection: Discontinue sarilumab.
Thrombocytopenia:
Platelets 50,000 to ≤100,000/mm3: Hold sarilumab; decision to restart therapy should be individualized.
Platelets ≤50,000/mm3: Discontinue sarilumab.
Altered kidney function: Children ≥2 years weighing ≥63 kg and Adolescents weighing ≥63 kg:
Mild to moderate impairment: No dosage adjustment necessary.
Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Hepatic impairment prior to initiation (baseline):There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Sarilumab is not recommended for use in patients with active hepatic disease or hepatic impairment.
Hepatotoxicity during treatment:
Children ≥2 years weighing ≥63 kg and Adolescents weighing ≥63 kg:
ALT >3 to ≤5 × ULN: Hold sarilumab; decision to restart therapy should be individualized.
ALT >5 × ULN: Discontinue sarilumab.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Incidence as reported for combination therapy with nonbiological disease-modifying antirheumatic drugs in adults with rheumatoid arthritis unless otherwise noted.
>10%: Hepatic: Increased serum alanine aminotransferase (≤3 × ULN: 5% to 43%), increased serum aspartate aminotransferase (≤3 × ULN: 30%)
1% to 10%:
Endocrine & metabolic: Hypertriglyceridemia (1%)
Gastrointestinal: Oral herpes simplex infection (<2%)
Genitourinary: Urinary tract infection (3%)
Hematologic & oncologic: Decreased platelet count (1%), leukopenia (2%), neutropenia (10%)
Immunologic: Antibody development (monotherapy: 9%; neutralizing: 7%)
Local: Injection-site reaction (7%; including erythema at injection site [4%], injection-site pruritus [2%])
Respiratory: Nasopharyngitis (≤4%), upper respiratory tract infection (3%)
<1%:
Gastrointestinal: Gastrointestinal perforation
Hypersensitivity: Hypersensitivity reaction
Frequency not defined:
Endocrine & metabolic: Increased HDL cholesterol, increased LDL cholesterol
Hematologic & oncologic: Malignant neoplasm
Postmarketing: Infection: Infection (including bacterial infection, cellulitis, fungal infection [including candidiasis], infection due to an organism in genus Pneumocystis, mycobacterial infection, opportunistic infection, pneumonia, serious infection, tuberculosis, viral infection)
Hypersensitivity to sarilumab or any component of the formulation
Concerns related to adverse effects:
• GI perforation: Has been reported, typically secondary to diverticulitis or concomitant use of NSAIDs or corticosteroid therapy.
• Hematologic effects: Neutropenia and thrombocytopenia may occur; may require treatment interruption, dose modification, or discontinuation.
• Hepatotoxicity: Sarilumab is associated with transaminase elevations. Transaminase elevations are typically reversible and generally do not result in clinically evident hepatic injury; patients receiving concomitant hepatotoxic drugs (eg, methotrexate) are at an increased risk of developing elevated transaminases.
• Hyperlipidemia: Therapy is associated with increases in triglycerides, LDL, and/or HDL.
• Hypersensitivity reactions: Hypersensitivity reactions such as injection-site rash, rash, and urticaria have been reported. Patients should seek medical attention if symptoms of hypersensitivity reaction occur.
• Infection: Tuberculosis (TB) exposure, history of or current opportunistic infection, underlying conditions predisposing to infection, or patients residing in or with travel to areas of endemic TB or endemic mycosis. The most common serious infections occurring have included pneumonia and cellulitis; opportunistic infections reported have included TB, candidiasis, and pneumocystis. Patients may present with disseminated infection. Do not administer sarilumab to a patient with an active infection, including localized infection.
• Malignancy: Use of sarilumab may increase malignancy risk; impact on the development and course of malignancies is not fully defined; however, malignancies were observed in clinical trials.
• Tuberculosis: Both reactivation of TB infection (latent TB) and new infections have been reported. Evaluate patients for TB risk factors and test for TB infection prior to initiating treatment. Treat patients with TB infection before initiating sarilumab; consider anti-TB therapy prior to initiation of sarilumab in patients with a history of TB infection or disease (active TB) if adequate course of treatment cannot be confirmed, and for patients with risk factors for TB despite a negative test. Some patients who test negative prior to therapy may develop active infection.
• Viral reactivation: Viral reactivation has been observed with immunosuppressive biologic therapy. Herpes zoster has been reported in patients receiving sarilumab. The risk for hepatitis B reactivation with sarilumab therapy is unknown; monitor for signs/symptoms of viral reactivation.
Special populations:
• Older adult: Infection has been reported at a higher incidence in older patients compared with younger adults; use with caution in older patients.
Other warnings/precautions:
• Immunizations: Patients should be up to date with all immunizations according to current immunization guidelines before initiating sarilumab therapy. Avoid concurrent use of live vaccines. No data is available concerning secondary transmission of infection from patients receiving live vaccines to patients receiving sarilumab.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Auto-injector, Subcutaneous [preservative free]:
Kevzara: 150 mg/1.14 mL (1.14 mL); 200 mg/1.14 mL (1.14 mL)
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Kevzara: 150 mg/1.14 mL (1.14 mL); 200 mg/1.14 mL (1.14 mL)
No
Solution Auto-injector (Kevzara Subcutaneous)
150MG/1.14ML (per mL): $2,423.00
200MG/1.14ML (per mL): $2,423.00
Solution Prefilled Syringe (Kevzara Subcutaneous)
150MG/1.14ML (per mL): $2,423.00
200MG/1.14ML (per mL): $2,423.00
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution Auto-injector, Subcutaneous:
Kevzara: 150 mg/1.14 mL (1.14 mL); 200 mg/1.14 mL (1.14 mL)
Solution Prefilled Syringe, Subcutaneous:
Kevzara: 150 mg/1.14 mL ([DSC]); 200 mg/1.14 mL (1.14 mL)
SUBQ: Administer subcutaneously. Rotate injection sites; may inject into the thigh, abdomen (avoiding the 2-inch area around the navel), or outer area of upper arm. Allow prefilled syringe and prefilled pen to sit at room temperature for 30 or 60 minutes, respectively, prior to use; do not warm in any other way. Solution should be clear and colorless to pale yellow; do not shake. Administer the full amount in the prefilled syringe or prefilled pen; do not administer if window on pen is solid yellow (indicates pen has been used). Do not inject into skin that is tender, damaged, or has bruises or scars.
IV (off-label route): Using SUBQ formulation, dilute in 100 mL NS and administer over 1 hour (Ref).
SUBQ: Allow prefilled syringe to sit at room temperature for 30 minutes prior to administration. Administer SUBQ using the prefilled syringe into the thigh, abdomen (avoiding the 2-inch area around the navel), or outer area of upper arm. Rotate injection sites; do not inject into areas that are tender, damaged, bruised, or have scars. Do not use if solution cloudy, discolored, or contains particles.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Kevzara https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761037s013lbl.pdf#page=31
Polyarticular juvenile idiopathic arthritis: Treatment of active polyarticular juvenile idiopathic arthritis in patients ≥63 kg.
Polymyalgia rheumatica: Treatment of polymyalgia rheumatica in adults who have had an inadequate response to corticosteroids or who cannot tolerate a corticosteroid taper.
Rheumatoid arthritis: Treatment of moderate to severe active rheumatoid arthritis in adults who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs.
COVID-19, hospitalized patients
Sarilumab may be confused with adalimumab, certolizumab pegol, golimumab, siltuximab, tocilizumab.
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
Anifrolumab: Biologic Disease-Modifying Antirheumatic Drugs may increase immunosuppressive effects of Anifrolumab. 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
BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Belimumab: May increase immunosuppressive effects of Biologic Disease-Modifying Antirheumatic Drugs. Management: Consider alternatives to the use of belimumab with other biologic therapies. Monitor closely for increased toxicities related to additive immunosuppression (ie, infection, malignancy) if combined. Risk D: Consider Therapy Modification
Biologic Disease-Modifying Antirheumatic Drugs: May increase immunosuppressive effects of Biologic Disease-Modifying Antirheumatic Drugs. 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
Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). 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
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor
COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
CycloSPORINE (Systemic): Interleukin-6 (IL-6) Inhibiting Therapies may decrease serum concentration of CycloSPORINE (Systemic). Risk C: Monitor
CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers): Interleukin-6 (IL-6) Inhibiting Therapies may decrease serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor
CYP2C9 Substrates (Narrow Therapeutic Index/Sensitive with Inducers): Interleukin-6 (IL-6) Inhibiting Therapies may decrease serum concentration of CYP2C9 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor
CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers): Interleukin-6 (IL-6) Inhibiting Therapies may decrease serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
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
HMG-CoA Reductase Inhibitors (Statins): Interleukin-6 (IL-6) Inhibiting Therapies may decrease serum concentration of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor
Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification
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
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
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
Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. 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
Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. 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
Theophylline: Interleukin-6 (IL-6) Inhibiting Therapies may decrease serum concentration of Theophylline. Risk C: Monitor
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
Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. 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
Vaccines (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider Therapy Modification
Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. 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
The effectiveness of oral contraceptives may be decreased during therapy and for several weeks after sarilumab is discontinued.
Sarilumab is a humanized monoclonal antibody (IgG1). Human IgG crosses the placenta. Fetal 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).
Based on animal data and the mechanism of action, maternal use of sarilumab may delay parturition. Outcome data following use of sarilumab for rheumatoid arthritis (Dernoncourt 2023; Mizutani 2023) or COVID-19 (Nana 2024) during pregnancy are limited.
Immune response in infants exposed to sarilumab in utero may be affected. Consider risks/benefits prior to administering live or live-attenuated vaccines to infants exposed to sarilumab during pregnancy.
Sarilumab is currently under study for the treatment of COVID-19. The risk of severe morbidity and mortality from COVID-19 infection is increased in symptomatic pregnant patients compared to nonpregnant patients. Pregnant and recently pregnant patients with moderate or severe infection are at increased risk of complications such as hypertensive disorders of pregnancy, postpartum hemorrhage, or other infections compared to pregnant patients without COVID-19. Symptomatic pregnant patients may require ICU admission, mechanical ventilation, or ventilatory support (ECMO). Other adverse pregnancy outcomes include preterm birth and stillbirth. The risk of coagulopathy, cesarean delivery, and maternal death may be increased; neonates have an increased risk for NICU admission. Maternal age and comorbidities such as diabetes, hypertension, lung disease, and obesity may also increase the risk of severe illness in pregnant and recently pregnant patients (ACOG 2023; NIH 2022)
In general, the treatment of COVID-19 infection during pregnancy is the same as in nonpregnant patients. However, because data for most therapeutic agents in pregnant patients are limited, treatment options should be evaluated as part of a shared decision-making process. Data are insufficient to make recommendations for use of sarilumab in pregnant patients (NIH 2022). Information related to the treatment of COVID-19 during pregnancy continues to emerge; refer to current guidelines for the treatment of pregnant patients.
Sarilumab is present in breast milk (Saito 2024).
Sarilumab is a humanized monoclonal antibody (IgG1). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).
Outcome data following use of sarilumab for rheumatoid arthritis in a breastfeeding patient are limited (Mizutani 2023). 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.
Breast milk has not been found to be a source of COVID-19 infection and maternal infection is not a contraindication to breastfeeding. The decision to breastfeed during treatment for COVID-19 should be evaluated as part of a shared decision-making process. However, lactating patients with COVID-19 infection can transmit the virus through respiratory droplets and all precautions should be taken to avoid spreading the virus to the infant (eg, hand hygiene, mask wearing); alternatively, breast milk can be expressed and fed to the infant by someone without confirmed or suspected COVID-19 (ACOG 2023; NIH 2022).
Information related to COVID-19 and breastfeeding is available from the World Health Organization (https://www.who.int/news/item/28-04-2020-new-faqs-address-healthcare-workers-questions-on-breastfeeding-and-covid-19).
Latent TB screening prior to therapy initiation and during therapy; neutrophils, platelets, ALT/AST (prior to therapy, 4 to 8 weeks after start of therapy, and every 3 months thereafter); additional liver function tests (eg, bilirubin) as clinically indicated; lipid panel (4 to 8 weeks following initiation and approximately every 6 months during therapy); signs/symptoms of infection (prior to, during, and after therapy), hypersensitivity reaction, new onset abdominal symptoms, and active tuberculosis.
Sarilumab is an interleukin-6 (IL-6) receptor antagonist which binds to both soluble and membrane-bound IL-6 receptors. Endogenous IL-6 is induced by inflammatory stimuli and mediates a variety of immunological responses. IL-6 produced by synovial and endothelial cells leads to local production of IL-6 in joints affected by inflammatory processes such as rheumatoid arthritis. Inhibition of IL-6 receptors by sarilumab leads to a reduction in CRP levels.
Distribution: Vdss = 7.3 L
Half-life elimination: Concentration dependent:
200 mg every 2 weeks: Up to 10 days
150 mg every 2 weeks: Up to 8 days
Time to peak: 2 to 4 days
Excretion: Elimination is predominantly through the linear, non-saturable proteolytic pathway at high concentrations; at lower concentrations, elimination is predominately through non-linear saturable target-mediated pathway.
There was a trend toward higher apparent clearance of sarilumab in the presence of anti-sarilumab antibodies.
