Prescription medicine
Sarilumab Brand names: Kevzara
Sarilumab (Kevzara) is a prescription medicine with an FDA approval on record since 2017. No generic is listed; pharmacies paid $2,075.30 per mL (Kevzara 200 mg/1.14 mL pen injection) in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the sarilumab FDA label on DailyMed (effective February 27, 2026, Sanofi-Aventis U.S. LLC); the BLA 761037 record on Drugs@FDA; every sarilumab label on DailyMed.
Highlights of the record
FDA label of February 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
RISK OF SERIOUS INFECTIONS.
Patients treated with KEVZARA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1), Adverse Reactions (6.1) ]. Opportunistic infections have also been reported in patients receiving KEVZARA. Most patients who developed infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid use of KEVZARA 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 KEVZARA use and during therapy. Treatment for latent infection should be initiated prior to KEVZARA 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 KEVZARA. If a serious infection develops, interrupt KEVZARA until the infection is controlled. Consider the risks and benefits of treatment with KEVZARA prior to initiating therapy in patients with chronic or recurrent infection. […]
Used for
From the label: indications and usageKEVZARA ® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).
Forms and strengths
- 150 mg/1.14ml
- 200 mg/1.14ml
Injection (solution).
On the market
- Earliest approval on file
- May 22, 2017 Kevzara, Sanofi Synthelabo; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $2,075.30 per mL Kevzara 200 mg/1.14 mL pen injection
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 26,260 through July 30, 2026
What is sarilumab used for?
From the label: indications and usageKEVZARA ® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). ( 1.1 ) adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. ( 1.2 ) patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). […]
Conditions named in the indications of sarilumab's FDA labels, with every medicine labeled for each:
From other sarilumab labelsRheumatoid arthritis: Arthritis (RA) KEVZARA ® is indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).
FDA pharmacologic class: Interleukin-6 Receptor Antagonist.
Source: FDA drug label (KEVZARA), Sanofi-Aventis U.S. LLC, effective February 27, 2026 (SPL set 827bc01c-d379-4266-a18c-c7f904b76af3), via openFDA; the full label on DailyMed
What does the patient leaflet for sarilumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about KEVZARA?KEVZARA can cause serious side effects including: 1. Serious Infections. KEVZARA is a prescription medicine that affects your immune system. KEVZARA can lower the ability of your immune system to fight infections. Some people have serious infections while using KEVZARA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should test you or your child for TB before starting KEVZARA. Your healthcare provider should monitor you closely for signs and symptoms of TB during treatment with KEVZARA. You should not start using KEVZARA if you have any kind of infection unless your healthcare provider says it is okay. Before starting KEVZARA, tell your healthcare provider if you: think you have an infection or have signs or symptoms of an infection, with or without a fever, such as: sweats or chills muscle aches cough shortness of breath blood in your phlegm weight loss warm, red or painful skin or sores on your body diarrhea or stomach pain burning when you urinate or urinating more often than normal feeling very tired are being treated for an infection. get a lot of infections or have infections that keep coming back. have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance of getting infections. have TB, or have been in close contact with someone with TB. live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance of getting certain fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen more often or become more severe if you use KEVZARA. […]
From the patient leaflet: How should I store KEVZARA?Store KEVZARA in the refrigerator between 36°F to 46°F (2°C to 8°C). Store KEVZARA in the original carton until use to protect it from light. Do not freeze KEVZARA. Do not shake KEVZARA. KEVZARA may be stored at room temperature up to 77°F (25°C) for up to 14 days in the original outer carton. Throw away KEVZARA if it has been kept at room temperature and not been used within 14 days. Keep KEVZARA and all medicines out of the reach of children. General Information about the safe and effective use of KEVZARA. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use KEVZARA for a condition for which it was not prescribed. Do not give KEVZARA to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about KEVZARA that is written for health professionals.
Source: FDA drug label (KEVZARA), Sanofi-Aventis U.S. LLC, effective February 27, 2026 (SPL set 827bc01c-d379-4266-a18c-c7f904b76af3), via openFDA; the full label on DailyMed
Is there a generic for sarilumab (Kevzara)?
No generic sarilumab is approved (Drugs@FDA, October 8, 2026).
- 2017 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for sarilumab (Kevzara)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2,075.30 per mL (Kevzara 200 mg/1.14 mL pen injection), up 6% from $1,956.58 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Kevzara 200 mg/1.14 mL syringe (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Kevzara 200 mg/1.14 mL pen injection | Brand | $2,075.30 per mL | $2,365.84 per pen | +6% |
| Kevzara 200 mg/1.14 mL syringe | Brand | $2,068.06 per mL | $2,357.59 per syringe | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the sarilumab label say about other medicines?
The sarilumab label names 5 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atorvastatin | drug interactions | 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) ]. |
| Lovastatin | drug interactions | 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) ]. |
| Methotrexate | boxed warning | Most patients who developed infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. |
| Theophylline | drug interactions | 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. |
| Warfarin | drug interactions | 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. |
Source: FDA drug label (KEVZARA), Sanofi-Aventis U.S. LLC, effective February 27, 2026 (SPL set 827bc01c-d379-4266-a18c-c7f904b76af3), via openFDA; the full label on DailyMed
What do FAERS reports show for sarilumab?
The FDA Adverse Event Reporting System holds 26,260 reports that list sarilumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,540 are coded as a death and 4,422 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as sarilumab?
8 other medicines are given the same way (subcutaneous) and in the same FDA class as sarilumab or labeled mainly for the same use (rheumatoid arthritis), the same class first. Rheumatoid arthritis lists all 46 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Tocilizumab | Rheumatoid arthritis | none listed | $821.00 per mL 162 mg/0.9 mL autoinjct | No current entry |
| Adalimumab | Rheumatoid arthritis | none listed | $1,587.82 per mL 40 mg/0.4 mL | No current entry |
| Methotrexate | Rheumatoid arthritis | none listed | $289.37 per mL 25 mg/0.5 mL autoinj | In shortage |
| Etanercept | Rheumatoid arthritis | none listed | $2,084.14 per mL 25 mg/0.5 mL syringe | No current entry |
| Abatacept | Rheumatoid arthritis | none listed | $1,469.23 per mL 125 mg/mL syringe | No current entry |
| Certolizumab | Rheumatoid arthritis | none listed | $6,094.02 per syringe 2x200 mg/mL syringe kit | No current entry |
| Golimumab | Rheumatoid arthritis | none listed | $12,890.32 per mL 50 mg/0.5 mL pen injec | No current entry |
| Adalimumab-aacf | Rheumatoid arthritis | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to sarilumab
- 8 medicines for the same use
- Other interleukin-6 receptor antagonists
- the pharmacologic class, with prices and generics
- Sarilumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other