Dosing & Uses
Dosage Forms & Strengths
injectable solution (prefilled syringe)
- 150mg/1.14mL
- 200mg/1.14mL
injectable solution (prefilled pen)
- 150mg/1.14mL
- 200mg/1.14mL
Rheumatoid Arthritis
Indicated for adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to ≥1 disease-modifying antirheumatic drugs (DMARDs)
200 mg SC q2wk
May be used as monotherapy or in combination with methotrexate (MTX) or other conventional DMARDs
Polymyalgia Rheumatica
Indicated for adults with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper
200 mg SC q2wk
Use in combination with a tapering course of systemic corticosteroids or as monotherapy following discontinuation of corticosteroids
Coronavirus Disease 2019 (COVID-19) (Off-label)
Data available as of March 1, 2023
Sarilumab may be part of an investigational protocol for hospitalized adults with progressive or critical COVID-19 who have elevated markers of systemic inflammation when tocilizumab is not available
For guidelines, see the Infectious Disease Society of America (IDSA) website (link https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/#Recommendations11-12:IL-6inhibitorstocilizumabandsarilumab)
Additional Medscape COVID-19 references are available
- Coronavirus Disease 2019 (COVID-19) (link https://emedicine.medscape.com/article/2500114-overview)
- Novel Coronavirus Resource Center (link https://www.medscape.com/resource/coronavirus)
Dosage Modifications
Serious or opportunistic infection: Hold treatment until infection is controlled
RA
-
ANC
- >1000 cells/mm³: Maintain current dose
- 500-1000 cells/mm³: Hold treatment until ANC >1000; resume at 150 mg q2wk and increase to 200 mg q2wk as clinically appropriate
- <500 cells/mm³: Discontinue
-
Low Platelets
- 50,000-100,000 cells/mm³: Hold treatment until platelets >100,000; resume at 150 mg q2wk and increase to 200 mg q2wk as clinically appropriate
- <50,000 cells/mm³: If confirmed by repeat testing, discontinue
-
Liver enzyme abnormalities
- ALT or AST >ULN to <3 x ULN: Consider dosage modification of concomitant DMARDs as clinically appropriate
- ALT or AST 3-5 x ULN: Hold treatment until ALT <3 x ULN; resume at 150 mg q2wk and increase to 200 mg q2wk as clinically appropriate
- ALT or AST >5 x ULN: Discontinue
PMR
-
Discontinue if
- Neutropenia (ANC <1000 cells/mm3 at end of dosing interval)
- Thrombocytopenia (platelet count <100,000/mm3)
- AST or ALT increased >3 x ULN
- Dosage modifications have not been studied in patients with PMR with these conditions
Renal impairment
- Mild-to-moderate: No dose adjustment required
- Severe: Not studied
Hepatic impairment
- Not studied
Dosing Considerations
Assess platelet count prior to initiation of therapy and monitor platelets 4 to 8 weeks after start of therapy and every 3 months thereafter
Initiation not recommended with ANC <2000/mm³, platelets <150,000/mm³, or ALT or AST >1.5 x ULN
Test for latent tuberculosis (TB) before initiating; if positive, consider treating for TB before using sarilumab
Avoid coadministering with biological DMARDs (eg, TNF antagonists, IL-1R antagonists, antiCD20 monoclonal antibodies, JAK inhibitors, selective costimulation modulators) because of increased risk for immunosuppression and infection; coadministration with biological DMARDs has not been studied
Avoid with active infections
Also see Black Box Warnings
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (20)
- adenovirus types 4 and 7 live, oral
sarilumab, adenovirus types 4 and 7 live, oral. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid concurrent use of live virus vaccines, owing to potentially increased risk of infections. The interval between live vaccinations and initiation of sarilumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
- anthrax vaccine adsorbed
sarilumab, anthrax vaccine adsorbed. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid concurrent use of live virus vaccines, owing to potentially increased risk of infections. The interval between live vaccinations and initiation of sarilumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
- axicabtagene ciloleucel
sarilumab, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- BCG vaccine live
sarilumab, BCG vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid concurrent use of live virus vaccines, owing to potentially increased risk of infections. The interval between live vaccinations and initiation of sarilumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
- brexucabtagene autoleucel
sarilumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cholera vaccine
sarilumab, cholera vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid concurrent use of live virus vaccines, owing to potentially increased risk of infections. The interval between live vaccinations and initiation of sarilumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
- ciltacabtagene autoleucel
sarilumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
sarilumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lisocabtagene maraleucel
sarilumab, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- measles (rubeola) vaccine
sarilumab, measles (rubeola) vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid concurrent use of live virus vaccines, owing to potentially increased risk of infections. The interval between live vaccinations and initiation of sarilumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
- measles, mumps, rubella and varicella vaccine, live
sarilumab, measles, mumps, rubella and varicella vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid concurrent use of live virus vaccines, owing to potentially increased risk of infections. The interval between live vaccinations and initiation of sarilumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
- rotavirus oral vaccine, live
sarilumab, rotavirus oral vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid concurrent use of live virus vaccines, owing to potentially increased risk of infections. The interval between live vaccinations and initiation of sarilumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
- rubella vaccine
sarilumab, rubella vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid concurrent use of live virus vaccines, owing to potentially increased risk of infections. The interval between live vaccinations and initiation of sarilumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
- smallpox (vaccinia) vaccine, live
sarilumab, smallpox (vaccinia) vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid concurrent use of live virus vaccines, owing to potentially increased risk of infections. The interval between live vaccinations and initiation of sarilumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
- tisagenlecleucel
sarilumab, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- typhoid vaccine live
sarilumab, typhoid vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid concurrent use of live virus vaccines, owing to potentially increased risk of infections. The interval between live vaccinations and initiation of sarilumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
- upadacitinib
sarilumab, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.
- varicella virus vaccine live
sarilumab, varicella virus vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid concurrent use of live virus vaccines, owing to potentially increased risk of infections. The interval between live vaccinations and initiation of sarilumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
- yellow fever vaccine
sarilumab, yellow fever vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid concurrent use of live virus vaccines, owing to potentially increased risk of infections. The interval between live vaccinations and initiation of sarilumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
- zoster vaccine live
sarilumab, zoster vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid concurrent use of live virus vaccines, owing to potentially increased risk of infections. The interval between live vaccinations and initiation of sarilumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
Monitor Closely (24)
- carbamazepine
sarilumab, carbamazepine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of cytokines such as IL-6. Elevated IL-6 concentration may down-regulate CYP activity, such as in patients with RA, and, hence, increase drug levels compared with subjects without RA. Blockade of IL-6 signaling by IL-6 antagonists (eg, sarilumab) might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to decreased drug concentrations. Caution when initiating or discontinuing sarilumab if coadministered with CYP450 substrates, especially those with a narrow therapeutic index.
- clonidine
sarilumab, clonidine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of cytokines such as IL-6. Elevated IL-6 concentration may down-regulate CYP activity, such as in patients with RA, and, hence, increase drug levels compared with subjects without RA. Blockade of IL-6 signaling by IL-6 antagonists (eg, sarilumab) might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to decreased drug concentrations. Caution when initiating or discontinuing sarilumab if coadministered with CYP450 substrates, especially those with a narrow therapeutic index.
- cyclosporine
sarilumab, cyclosporine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, sarilumab could normalize the formation of CYP450 enzymes thus decrease levels of CYP substrates. Upon initiation or discontinuation of sarilumab in patients who are receiving concomitant CYP450 substrates with a narrow therapeutic index, monitor therapeutic effect.
- dengue vaccine
sarilumab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- disopyramide
sarilumab, disopyramide. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of cytokines such as IL-6. Elevated IL-6 concentration may down-regulate CYP activity, such as in patients with RA, and, hence, increase drug levels compared with subjects without RA. Blockade of IL-6 signaling by IL-6 antagonists (eg, sarilumab) might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to decreased drug concentrations. Caution when initiating or discontinuing sarilumab if coadministered with CYP450 substrates, especially those with a narrow therapeutic index.
- efgartigimod alfa
efgartigimod alfa will decrease the level or effect of sarilumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- fosphenytoin
sarilumab, fosphenytoin. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of cytokines such as IL-6. Elevated IL-6 concentration may down-regulate CYP activity, such as in patients with RA, and, hence, increase drug levels compared with subjects without RA. Blockade of IL-6 signaling by IL-6 antagonists (eg, sarilumab) might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to decreased drug concentrations. Caution when initiating or discontinuing sarilumab if coadministered with CYP450 substrates, especially those with a narrow therapeutic index.
- isavuconazonium sulfate
sarilumab and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.
- lomustine
lomustine and sarilumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- mechlorethamine
mechlorethamine, sarilumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- ofatumumab SC
ofatumumab SC, sarilumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- phenobarbital
sarilumab, phenobarbital. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of cytokines such as IL-6. Elevated IL-6 concentration may down-regulate CYP activity, such as in patients with RA, and, hence, increase drug levels compared with subjects without RA. Blockade of IL-6 signaling by IL-6 antagonists (eg, sarilumab) might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to decreased drug concentrations. Caution when initiating or discontinuing sarilumab if coadministered with CYP450 substrates, especially those with a narrow therapeutic index.
- phenytoin
sarilumab, phenytoin. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of cytokines such as IL-6. Elevated IL-6 concentration may down-regulate CYP activity, such as in patients with RA, and, hence, increase drug levels compared with subjects without RA. Blockade of IL-6 signaling by IL-6 antagonists (eg, sarilumab) might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to decreased drug concentrations. Caution when initiating or discontinuing sarilumab if coadministered with CYP450 substrates, especially those with a narrow therapeutic index.
- primidone
sarilumab, primidone. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of cytokines such as IL-6. Elevated IL-6 concentration may down-regulate CYP activity, such as in patients with RA, and, hence, increase drug levels compared with subjects without RA. Blockade of IL-6 signaling by IL-6 antagonists (eg, sarilumab) might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to decreased drug concentrations. Caution when initiating or discontinuing sarilumab if coadministered with CYP450 substrates, especially those with a narrow therapeutic index.
- quinidine
sarilumab, quinidine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of cytokines such as IL-6. Elevated IL-6 concentration may down-regulate CYP activity, such as in patients with RA, and, hence, increase drug levels compared with subjects without RA. Blockade of IL-6 signaling by IL-6 antagonists (eg, sarilumab) might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to decreased drug concentrations. Caution when initiating or discontinuing sarilumab if coadministered with CYP450 substrates, especially those with a narrow therapeutic index.
- quinine
sarilumab, quinine. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of cytokines such as IL-6. Elevated IL-6 concentration may down-regulate CYP activity, such as in patients with RA, and, hence, increase drug levels compared with subjects without RA. Blockade of IL-6 signaling by IL-6 antagonists (eg, sarilumab) might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to decreased drug concentrations. Caution when initiating or discontinuing sarilumab if coadministered with CYP450 substrates, especially those with a narrow therapeutic index.
- sirolimus
sarilumab, sirolimus. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of cytokines such as IL-6. Elevated IL-6 concentration may down-regulate CYP activity, such as in patients with RA, and, hence, increase drug levels compared with subjects without RA. Blockade of IL-6 signaling by IL-6 antagonists (eg, sarilumab) might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to decreased drug concentrations. Caution when initiating or discontinuing sarilumab if coadministered with CYP450 substrates, especially those with a narrow therapeutic index.
- tacrolimus
sarilumab, tacrolimus. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of cytokines such as IL-6. Elevated IL-6 concentration may down-regulate CYP activity, such as in patients with RA, and, hence, increase drug levels compared with subjects without RA. Blockade of IL-6 signaling by IL-6 antagonists (eg, sarilumab) might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to decreased drug concentrations. Caution when initiating or discontinuing sarilumab if coadministered with CYP450 substrates, especially those with a narrow therapeutic index.
- theophylline
sarilumab, theophylline. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of cytokines such as IL-6. Elevated IL-6 concentration may down-regulate CYP activity, such as in patients with RA, and, hence, increase drug levels compared with subjects without RA. Blockade of IL-6 signaling by IL-6 antagonists (eg, sarilumab) might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to decreased drug concentrations. Caution when initiating or discontinuing sarilumab if coadministered with CYP450 substrates, especially those with a narrow therapeutic index.
- trastuzumab
trastuzumab, sarilumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.
- trastuzumab deruxtecan
trastuzumab deruxtecan, sarilumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.
- ublituximab
ublituximab and sarilumab both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
- valproic acid
sarilumab, valproic acid. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of cytokines such as IL-6. Elevated IL-6 concentration may down-regulate CYP activity, such as in patients with RA, and, hence, increase drug levels compared with subjects without RA. Blockade of IL-6 signaling by IL-6 antagonists (eg, sarilumab) might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to decreased drug concentrations. Caution when initiating or discontinuing sarilumab if coadministered with CYP450 substrates, especially those with a narrow therapeutic index.
- zoster vaccine recombinant
sarilumab decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.
Minor (0)
Adverse Effects
>10%
ALT >ULN to ≤3 x ULN (38-43%)
AST >ULN to ≤3 x ULN (27-30%)
1-10%
Neutropenia (7-10%)
ANC <1000/mm³ (4-6%)
Injection site erythema (4-5%)
Injection site pruritics (4-5%)
Upper respiratory tract infection (3-4%)
ALT >3x to 5x ULN (3-4%)
Urinary tract infection (3%)
Hypertriglyceridemia (1-3%)
Leukopenia (0.9-2%)
AST >3x to 5x ULN (1%)
ALT>5x ULN (0.7-1%)
Decreased platelet counts (0.7-1%)
<1%
ANC <500 /mm³ (0.7%)
AST>5x ULN (0.2-0.7%)
Warnings
Black Box Warnings
Serious infections
- Use of sarilumab increases risk for developing serious infections that may lead to hospitalization or death
- Opportunistic infections reported
- Most patients who developed infections were taking concomitant immunosuppressants (eg, methotrexate, corticosteroids)
- Avoid use in patients with active infection
- Closely monitor for signs and symptoms of infection during treatment; if a serious infection develops, interrupt sarilumab therapy until the infection is controlled
- Consider the risks and benefits of using sarilumab before initiating in patients with chronic or recurrent infection; a history of opportunistic infections, underlying conditions, in addition to RA, that may predispose them to infection, have been exposed to tuberculosis, or lived in or traveled to areas of endemic tuberculosis or endemic mycoses
Reported infections include
- Active tuberculosis, which may present with pulmonary or extrapulmonary disease; test for latent TB before and during therapy; treatment for latent infection should be initiated before sarilumab is started; closely monitor patients for the development of signs and symptoms of TB including patients who tested negative for latent TB infection prior to initiating therapy
- Invasive fungal infections (eg, candidiasis, pneumocystis); patients with invasive fungal infections may present with disseminated, rather than localized, disease
- Bacterial, viral, and other infections due to opportunistic pathogens
Contraindications
Documented hypersensitivity to drug or inactive ingredients
Cautions
Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported (see Black Box Warnings)
GI perforations reported in clinical studies, primarily as complications of diverticulitis; GI perforation risk may be increased with concurrent diverticulitis or concomitant use of NSAIDs or corticosteroids
Immunosuppression may result in an increased risk of malignancies
Hypersensitivity reactions reported
Not recommended with active hepatic disease or hepatic impairment
Laboratory abnormalities
- Neutropenia, thrombocytopenia, elevated liver enzymes, and lipid abnormalities reported (see Dosage Modifications)
- Assess platelet count prior to initiation of therapy and monitor platelets 4 to 8 weeks after start of therapy and every 3 months thereafter
- Assess ALT/AST levels prior to initiation of therapy and monitor ALT and AST levels 4 to 8 weeks after start of therapy and every 3 months thereafter; when clinically indicated, consider other liver function tests such as bilirubin
- Assess lipid parameters approximately 4-8 weeks following initiation of therapy, then at approximately 6-month intervals; manage patients according to clinical guidelines for the management of hyperlipidemia
Drug interaction overview
Live virus vaccines
- Avoid concurrent use of live virus vaccines, owing to potentially increased risk of infections
- The interval between live vaccinations and initiation of sarilumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents
CYP450 substrates
- The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (eg, IL-1, IL-6, IL-10, TNF-alpha, IFN) during chronic inflammation
- Elevated IL-6 concentration may down-regulate CYP activity, such as in patients with RA, and, hence, increase drug levels compared with subjects without RA
- Blockade of IL-6 signaling by IL-6 antagonists (eg, sarilumab) might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to decreased drug concentrations
- Caution when initiating or discontinuing sarilumab if coadministered with CYP450 substrates, especially those with a narrow therapeutic index
Biological DMARDs
- Avoid coadministering with biological DMARDs (eg, TNF antagonists, IL-1R antagonists, antiCD20 monoclonal antibodies, JAK inhibitors, selective costimulation modulators) because of increased risk for immunosuppression and infection
- Coadministration with biological DMARDs has not been studied
Pregnancy
Pregnancy
Limited human data in pregnant women are not sufficient to inform drug-associated risk for major birth defects and miscarriage
Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester
Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed in utero
From the animal data, and consistent with the mechanism of action, levels of IgG, in response to antigen challenge, may be reduced in the fetus/infant of treated mothers
Pregnancy registry
- There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to sarilumab during pregnancy
- Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-311-8972
Lactation
Unknown if distributed in human breast milk
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Human monoclonal antibody that binds to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and has been shown to inhibit IL-6-mediated signaling through these receptors
IL-6 is produced by synovial and endothelial cells leading to local production of IL-6 in joints affected by inflammatory processes (eg, rheumatoid arthritis)
IL-6 is a pleiotropic proinflammatory cytokine produced by a variety of cell types including T- and B-cells, lymphocytes, monocytes, and fibroblasts
IL-6 has been shown to be involved in diverse physiological processes (eg, T-cell activation, induction of immunoglobulin secretion, initiation of hepatic acute-phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation
Absorption
Peak plasma time: 2-4 days
Peak plasma concentration: 20 mg/L (150 mg SC q2Weeks); 35.6 mg/L (200 mg SC q2Weeks)
Minimum plasma concentration: 6.35 mg/L (150 mg SC q2Weeks); 16.5 mg/L (200 mg SC q2Weeks)
AUC: 202 mg·day/L (150 mg SC q2Weeks); 395 mg·day/L (200 mg SC q2Weeks)
Steady state: Reached in 14-16 weeks
Distribution
Vd: 7.3 L
Metabolism
Expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG
Elimination
Half-life: 10 days (200 mg q2wk); 8 days (150 mg q2wk)
Excretion: Monoclonal antibodies are not eliminated via renal or hepatic pathways
Administration
SC Preparation
Remove from refrigerator and allow to sit at room temperature for 30 minutes (prefilled syringes) or 60 minutes (prefilled pen) y
Visually inspect syringe for particulate matter and discoloration prior to administration
Solution should be clear and colorless to pale yellow; do not use if the solution is cloudy, discolored, or contains particles, or if any part of the prefilled syringe appears to be damaged
SC Administration
Patient may self-inject or the patient's caregiver may administer after properly instructed
Instruct patients to inject the full amount in the syringe (1.14 mL), which provides 200 mg or 150 mg
Rotate injection sites with each injection; do not inject into skin that is tender, damaged, or has bruises or scars
Do not rub the injection site
Storage
Refrigerate at 36-46°F (2-8°C) in original carton to protect from light
Do not freeze
If needed, may store at room temperature up to 77°F (25°C) up to 14 days in the outer carton; do not store above 77°F (25°C)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Kevzara subcutaneous - | 200 mg/1.14 mL injection |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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