Sarilumab Injection
Sarilumab Injection is an interleukin-6 (IL-6) blocker given under the skin to treat rheumatoid arthritis, polymyalgia rheumatica, and polyarticular juvenile idiopathic arthritis.
Built from the FDA-approved label, dated Feb 27, 2026 · How this page is built
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Kevzara raises the risk of serious infections that can lead to hospitalization or death. These include tuberculosis, fungal infections, and bacterial or viral infections. Risk is higher in people also taking immune-suppressing medicines such as methotrexate or corticosteroids.
You should be tested for TB before starting and during treatment, and should not start Kevzara with an active infection. If a serious infection develops, Kevzara should be paused until it is controlled. Report any signs of infection to your doctor right away.
⚡ Quick answers about Sarilumab Injection
What is Kevzara for?
It treats rheumatoid arthritis in adults after other DMARDs didn't work well enough or weren't tolerated.
Read the full answer →How do I take it?
It's an injection under the skin, usually every two weeks. Let the syringe or pen come to room temperature first, check that the liquid is clear to pale yellow, and rotate injection sites.
Read the full answer →What side effects should I expect?
Common ones include injection site redness or itching, colds and urinary infections, and changes in blood tests like low neutrophils or raised liver enzymes. That's why you'll need regular blood work.
See it in the FAQ →When should I call my doctor?
Call right away if you have fever, chills, cough, or other signs of infection. Also call for allergic reaction signs like hives or trouble breathing, or new belly pain.
Read the full answer →🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
How we combine label and product data →📖 Sarilumab Injection: Patient Information Guide
A plain-language walkthrough of Sarilumab Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
What Sarilumab Injection is used for
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Sarilumab Injection treats several inflammatory conditions. Uses by product:
- Kevzara: moderately to severely active rheumatoid arthritis in adults who had an inadequate response or intolerance to one or more DMARDs.
- Kevzara: polymyalgia rheumatica in adults who had an inadequate response to corticosteroids or cannot tolerate a corticosteroid taper.
- Kevzara: active polyarticular juvenile idiopathic arthritis in patients who weigh 63 kg or more.
How Sarilumab Injection works
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Sarilumab binds to IL-6 receptors, both free-floating and on cell surfaces, and blocks IL-6 signaling. IL-6 is a pro-inflammatory protein involved in immune activation and inflammation. It is also made locally in joints affected by conditions like rheumatoid arthritis, so blocking it helps reduce that inflammation.
How Sarilumab Injection is taken (dosage)
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Kevzara is injected under the skin, generally once every two weeks. Your doctor may adjust or pause treatment based on blood test results or infections.
- It can be used alone or with other conventional DMARDs such as methotrexate for rheumatoid arthritis and pJIA.
- For polymyalgia rheumatica, it is used with a tapering course of corticosteroids, and can be used alone after steroids are stopped.
- Patients or caregivers can inject it after training. Rotate injection sites and avoid skin that is tender, bruised, damaged, or scarred.
- Follow your prescriber and the Instructions for Use for dosing and missed doses.
Dosing details from the FDA-approved label
From the Sarilumab Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION General Considerations for Administration KEVZARA initiation is not recommended in patients with ANC less than 2,000/mm 3 , platelets less than 150,000/mm 3 or liver transaminases above 1.5 times ULN. See Full Prescribing Information (FPI) for complete information. ( 2.1 ) Recommended Dosage in RA The recommended dosage is 200 mg subcutaneously, once every 2 weeks. ( 2.2 ) For RA, KEVZARA may be used as monotherapy or in combination with methotrexate (MTX) or other conventional DMARDs. ( 2.2 ) Recommended Dosage in PMR The recommended dosage is 200 mg subcutaneously, once every two weeks in combination with a tapering course of corticosteroids. ( 2.3 ) For PMR, KEVZARA can be used as monotherapy following discontinuation of corticosteroids. ( 2.3 ) Recommended Dosage in pJIA The recommended dosage is 200 mg given subcutaneously once every 2 weeks for pJIA patients who weigh 63 kg or greater using the 200 mg/1.14 mL pre-filled syringe. ( 2.4 ) For pJIA, KEVZARA can be used as monotherapy or in combination with conventional DMARDs. ( 2.4 ) Dosage Modifications for Cytopenias, Abnormal Liver Enzymes, Infections See FPI for complete information. ( 2.6 ) 2.1 General Considerations Prior to Administration Not Recommended for Concomitant Use with Biological DMARDS The concurrent use of KEVZARA with biological DMARDs such as tumor necrosis factor (TNF) antagonists, IL-1R antagonists, anti-CD20 monoclonal antibodies and selective co-stimulation modulators has not been studied. Avoid using KEVZARA with biological DMARDs because of the possibility of increased immunosuppression and increased risk of infection. Recommended Evaluations Prior to Treatment Complete blood count (CBC): Treatment initiation with KEVZARA is not recommended in patients with an absolute neutrophil count (ANC) below 2000 per mm 3 , or platelet count below 150,000 per mm 3 . Monitor laboratory parameters [see Warnings and Precautions (5.2) ]. Liver function tests (LFT): Treatment initiation with KEVZARA is not recommended in patients with or who have alanine transaminase (ALT) or aspartate aminotransferase (AST) above 1.5 times the upper limit of normal (ULN). Monitor laboratory parameters [see Dosage and Administration (2.6) and Warnings and Precautions (5.2) ] .
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Sarilumab Injection side effects in detail
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Common side effects
- Low neutrophil count (neutropenia), a type of white blood cell
- Raised liver enzyme (ALT) levels
- Redness or itching at the injection site
- Upper respiratory infections
- Urinary tract infections
- Low white blood cell count (leukopenia)
- Nasopharyngitis (common cold symptoms)
When to get medical help
- Call your doctor right away for signs of infection, such as fever, chills, cough, or burning when urinating. Kevzara can lessen typical signs of inflammation, so infections may be easy to miss.
- Get urgent help for signs of a serious allergic reaction, such as widespread rash, hives, or trouble breathing.
- Tell your doctor promptly about new or sudden stomach or abdominal pain. Tears (perforations) in the stomach or intestines have occurred.
- Report any signs of tuberculosis, such as a lingering cough.
- Tell your doctor about shingles (herpes zoster) symptoms.
Most side effects are mild, and common ones include:
- Low neutrophil count (neutropenia)
- Raised liver enzymes (ALT)
- Injection site redness or itching
- Upper respiratory and urinary tract infections
- Low white blood cell count (leukopenia)
- Nasopharyngitis in children with pJIA
Seek medical help for signs of infection, allergic reaction, or new abdominal pain.
Sarilumab Injection warnings and precautions
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- Serious infections, including tuberculosis and fungal infections, can be fatal. Avoid use during an active infection.
- Blood counts, liver enzymes, and lipids need regular monitoring.
- Stomach or intestinal tears have occurred, mostly in people with diverticulitis or those taking NSAIDs or corticosteroids.
- Allergic reactions can occur. Stop Kevzara and seek care if one happens.
- Avoid live vaccines.
- Immune-suppressing drugs may raise the risk of malignancies.
- Not recommended with active liver disease or liver impairment.
Sarilumab Injection interactions: what it interacts with
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Several medicines and situations need care with Kevzara:
- Live vaccines: higher infection risk.
- Biologic DMARDs: added immune suppression.
- JAK inhibitors: not studied together.
- Warfarin and theophylline: Kevzara may change how the body processes them, so monitoring is needed.
- Oral contraceptives, lovastatin, atorvastatin: they may work less well.
- NSAIDs and corticosteroids: may raise the risk of stomach or intestinal tears.
Interactions listed in the FDA-approved label
From the Sarilumab Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
7 DRUG INTERACTIONS 7.1 Use with Other Drugs Population pharmacokinetic analyses did not detect any effect of methotrexate (MTX) on sarilumab clearance. KEVZARA has not been investigated in combination with JAK inhibitors or biological DMARDs such as TNF antagonists [see Dosage and Administration (2.2) ] . 7.2 Interactions with CYP450 Substrates Various in vitro and limited in vivo human studies have shown that…
Read the label’s full interactions text
7 DRUG INTERACTIONS 7.1 Use with Other Drugs Population pharmacokinetic analyses did not detect any effect of methotrexate (MTX) on sarilumab clearance. KEVZARA has not been investigated in combination with JAK inhibitors or biological DMARDs such as TNF antagonists [see Dosage and Administration (2.2) ] . 7.2 Interactions with CYP450 Substrates Various in vitro and limited in vivo human studies have shown that cytokines and cytokine modulators can influence the expression and activity of specific cytochrome P450 (CYP) enzymes and therefore have the potential to alter the pharmacokinetics of concomitantly administered drugs that are substrates of these enzymes. Elevated interleukin-6 (IL-6) concentration may down-regulate CYP activity such as in patients with RA and hence increase drug levels compared to subjects without RA. Blockade of IL-6 signaling by IL-6Rα antagonists such as KEVZARA might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to altered drug concentrations. The modulation of IL-6 effect on CYP enzymes by KEVZARA may be clinically relevant for CYP substrates with a narrow therapeutic index, where the dose is individually adjusted. Upon initiation or discontinuation of KEVZARA, in patients being treated with CYP substrate medicinal products, perform therapeutic monitoring of effect (e.g., warfarin) or drug concentration (e.g., theophylline) and adjust the individual dose of the medicinal product as needed. Exercise caution when co-administering KEVZARA with CYP3A4 substrate drugs where decrease in effectiveness is undesirable, e.g., oral contraceptives, lovastatin, atorvastatin, etc. The effect of KEVZARA on CYP450 enzyme activity may persist for several weeks after stopping therapy [see Clinical Pharmacology (12.3) ]. 7.3 Live Vaccines Avoid concurrent use of live vaccines during treatment with KEVZARA [see Warnings and Precautions (5.7) ] .
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Sarilumab Injection
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- Do not use if allergic to sarilumab or its ingredients.
- Tell your doctor about any current, chronic or past serious infection, TB exposure, or travel to areas where TB or fungal infections are common.
- Tell your doctor about liver problems or hepatitis B or C.
- Pregnancy: use only if the benefit justifies the risk. Antibodies like sarilumab cross the placenta, mostly in the third trimester.
- Breastfeeding: effects on the infant are unknown, so discuss with your doctor.
- Children: approved only for pJIA at 63 kg or more.
- Older adults: infections are more common, so use caution.
- Severe kidney impairment has not been studied.
Pharmacodynamics: what Sarilumab Injection does in the body
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In people with rheumatoid arthritis, Kevzara quickly lowers CRP, a blood marker of inflammation, to normal levels within 2 weeks. Neutrophil counts dip at about 3 to 4 days after a dose, then recover. It also lowers fibrinogen and serum amyloid A and raises hemoglobin and albumin. In pJIA, CRP, ESR, and neutrophil counts also decreased.
Pharmacokinetics: how your body processes Sarilumab Injection
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After a subcutaneous injection, sarilumab peaks in about 2 to 4 days. Steady levels build up over weeks. Its half-life depends on concentration and is up to about 8 to 10 days in rheumatoid arthritis. As an antibody, it is broken down into small peptides and amino acids rather than cleared by the kidneys or liver. It can take 4 to 6 weeks to become undetectable after the last dose.
How to store Sarilumab Injection
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Refrigerate at 36°F to 46°F (2°C to 8°C) in original carton to protect from light. Do not freeze. store KEVZARA at room temperature up to 77°F (25°C) up to 14 days in the outer carton.
📄 Written from Sarilumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Sarilumab Injection
72 supplements and herbal products have documented interactions with Sarilumab Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Moderate · 71
- Minor · 1
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Sarilumab Injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Sarilumab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What is Kevzara for?
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How do I take it?
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What side effects should I expect?
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When should I call my doctor?
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Can I get vaccines or take my other medicines?
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What if I'm pregnant or breastfeeding?
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Is Sarilumab Injection available over the counter?
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When was Sarilumab Injection first available?
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Who makes Sarilumab Injection?
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💬 Answers drafted from Sarilumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 More about Sarilumab Injection on HelloPharmacist
💊 Sarilumab Injection forms and strengths (how it comes)
Sarilumab Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Kevzara is used for moderately to severely active rheumatoid arthritis in adults after inadequate response or intolerance to DMARDs.
- Kevzara is used for polymyalgia rheumatica in adults who did not respond well to corticosteroids or cannot taper them.
- Kevzara is used for active polyarticular juvenile idiopathic arthritis in patients weighing 63 kg or more.
- Kevzara is injected under the skin, usually once every two weeks.
- Kevzara pre-filled syringes should sit at room temperature for 30 minutes before use, and pre-filled pens for 60 minutes. Do not warm it any other way.
- Kevzara solution should be clear and colorless to pale yellow. Do not use it if cloudy, discolored, has particles, or the device looks damaged.
- Kevzara pre-filled syringe is used for pJIA patients; the pre-filled pen is not intended for pediatric patients.
📊 Sarilumab Injection on the U.S. market: products, makers and brands
How Sarilumab Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
3 companies list 16 Sarilumab Injection product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2017. Brand names on the directory include Kevzara; the rest are generics.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Sarilumab Injection is used (Medicaid data)
A general measure of how commonly Sarilumab Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Sarilumab Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Sarilumab Injection prescribed? Of the 1,599 medications we measure, Sarilumab Injection ranks #1,023 by Medicaid prescriptions — more than 36% of them.
Utilization by Sarilumab Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
1.14 ML sarilumab 175 MG/ML Auto-Injector Most dispensed
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2003766
1.14 ML sarilumab 175 MG/ML Prefilled Syringe
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1923345
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Sarilumab Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 6 listed Sarilumab Injection NDCs with Medicaid activity.
🔍 Compare Sarilumab Injection products
A representative set of FDA-listed product records for Sarilumab Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 131.1 mg/mL | — | Regeneron Pharmaceuticals, Inc | DRUG FOR FURTHER PROCESSING | View NDC → |
| 175 mg/mL | — | Regeneron Pharmaceuticals, Inc | DRUG FOR FURTHER PROCESSING | View NDC → |
| 150 mg/1.14 mL | Subcutaneous | Sanofi-Aventis U.S. LLC × 6 listings | BLA | View NDC → |
| 200 mg/1.14 mL | Subcutaneous | Sanofi-Aventis U.S. LLC × 6 listings | BLA | View NDC → |
| 150 mg/1.14 mL | — | Sanofi Winthrop Industrie | DRUG FOR FURTHER PROCESSING | View NDC → |
| 200 mg/1.14 mL | — | Sanofi Winthrop Industrie | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 16 of 16 products — FDA National Drug Code Directory. See every product, package size and price: browse all 16 Sarilumab Injection NDCs →
📈 Sarilumab Injection side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Sarilumab Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Sarilumab Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ Sarilumab Injection FDA approval history
How Sarilumab Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Sarilumab Injection recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1923319 2 dose forms · 4 strengths
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Dose form (SCDF) Auto-Injector RxCUI 2003754In current FDA listingsClinical drug / strength (SCD) 1.14 ML sarilumab 132 MG/MLRxCUI 20037551.14 ML sarilumab 175 MG/MLRxCUI 2003766 -
Dose form (SCDF) Prefilled Syringe RxCUI 1923332No current FDA listingClinical drug / strength (SCD) 1.14 ML sarilumab 132 MG/MLRxCUI 19233331.14 ML sarilumab 175 MG/MLRxCUI 1923345
Look up RxCUI 1923319 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Sarilumab Injection supply and shortage status
Whether Sarilumab Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sarilumab Injection brand names
Sarilumab Injection is sold under one brand name in the FDA directory — Kevzara. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
🏭 Who makes Sarilumab Injection: manufacturers and labelers
3 companies list Sarilumab Injection products with the FDA. By number of product records, the largest are sanofi-aventis U.S. LLC, Regeneron Pharmaceuticals, Inc, Sanofi Winthrop Industrie. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Sarilumab Injection drug class (RxNorm)
Sarilumab Injection belongs to the Interleukin-6 Receptor Antagonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Sources for this Sarilumab Injection page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. sanofi-aventis U.S. LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.