sarilumab
Brand names: Kevzara
Kevzara is a medicine that can help treat rheumatoid arthritis, polymyalgia rheumatica and polyarticular juvenile idiopathic arthritis. It works by blocking a protein in your body that causes inflammation.
Drug Pricing (NADAC)
Brand Price
$1852.54/unit
Generic Available
No
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Kevzara treats rheumatoid arthritis (RA) in adults when other medicines have not worked well enough.
Common side effects
Low white blood cell count (neutropenia), Increased liver enzyme levels, Redness at the injection site
Key warnings
Kevzara can increase your risk of serious infections that could lead to hospitalization or death.
How It Works
Kevzara is an interleukin-6 (IL-6) receptor antagonist. This means it blocks the IL-6 receptor. By blocking this receptor, Kevzara reduces inflammation in your body.
How to Take It
Kevzara is given as an injection under your skin (subcutaneously). For RA and PMR, the usual dose is 200 mg once every 2 weeks. For pJIA patients who weigh 63 kg or greater, the recommended dose is 200 mg once every 2 weeks. Your doctor may adjust your dose based on lab results.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Kevzara will harm your unborn baby. Talk to your doctor about the risks and benefits of taking Kevzara during pregnancy and breastfeeding.
Missed Dose
If you miss a dose of Kevzara, inject it as soon as you remember. Then, continue with your regular schedule.
Storage
Keep Kevzara in the refrigerator at 36°F to 46°F (2°C to 8°C) in its original carton to protect it from light. Do not freeze or shake it. If needed, you can store Kevzara at room temperature up to 77°F (25°C) for up to 14 days.
Side Effects (from patient reports)
Based on 40,317 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 23,683 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2015–2025.
Total Reports
23,683
Death-Related Reports
2,313
Hospitalization Reports
4,047
Top Indication
Rheumatoid Arthritis
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG INEFFECTIVE | 5,591 |
| 2 | PAIN | 5,313 |
| 3 | ARTHRALGIA | 4,655 |
| 4 | RHEUMATOID ARTHRITIS | 4,395 |
| 5 | JOINT SWELLING | 4,362 |
| 6 | CONDITION AGGRAVATED | 3,580 |
| 7 | FATIGUE | 3,334 |
| 8 | RASH | 3,212 |
| 9 | ALOPECIA | 2,969 |
| 10 | ABDOMINAL DISCOMFORT | 2,906 |
| 11 | HEPATIC ENZYME INCREASED | 2,858 |
| 12 | SYSTEMIC LUPUS ERYTHEMATOSUS | 2,780 |
| 13 | PEMPHIGUS | 2,721 |
| 14 | HAND DEFORMITY | 2,643 |
| 15 | GLOSSODYNIA | 2,625 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Kevzara can increase your risk of serious infections that could lead to hospitalization or death. Tell your doctor if you have an active infection before starting Kevzara. Your doctor should test you for tuberculosis (TB) before you start Kevzara. If you get a serious infection, your doctor will stop Kevzara treatment until the infection is controlled.
Known 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.
Mechanism: Sarilumab can make your body process atorvastatin more quickly than usual. This can make the atorvastatin less effective at lowering your cholesterol.
What to do: Your doctor should monitor your cholesterol levels closely. They may need to adjust your atorvastatin dose to ensure it is still working.
Exercise caution when co-administering KEVZARA with CYP3A4 substrate drugs where decrease in effectiveness is undesirable, e.g., oral contraceptives, lovastatin, atorvastatin, etc.
Mechanism: Sarilumab speeds up the way your body gets rid of lovastatin. This reduces the amount of medicine in your system, making it less effective.
What to do: Use caution when taking these drugs together and have your cholesterol checked regularly. Your doctor might need to increase your lovastatin dose.
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.
Mechanism: Sarilumab can change how quickly your body breaks down warfarin, which can affect how much your blood is thinned. This could lead to your blood being too thick or too thin.
What to do: Your doctor should monitor your blood clotting levels closely and may need to adjust your warfarin dose when you start or stop this treatment.
7 DRUG INTERACTIONS 7.1 Use with Other Drugs Population pharmacokinetic analyses did not detect any effect of methotrexate (MTX) on sarilumab clearance.
Mechanism: Methotrexate does not affect how the body processes or removes sarilumab.
What to do: No dose adjustments are needed when these two medications are used together.
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.
Mechanism: Sarilumab can change how the liver breaks down theophylline, which might change the amount of medicine in your blood.
What to do: Your doctor should monitor your theophylline levels and adjust your dose if necessary when starting or stopping sarilumab.
Common Questions
What should I tell my doctor before taking Kevzara?
Can I take Kevzara with other medicines?
How will my doctor monitor me while I'm taking Kevzara?
Can I get vaccines while taking Kevzara?
What are the signs of a serious infection?
What should I do if I have side effects?
Can Kevzara affect my cholesterol?
Is it safe to take Kevzara if I have diabetes?
How is Kevzara supplied?
What if I accidentally leave Kevzara out of the refrigerator?
What are the common side effects of sarilumab?
Does sarilumab interact with other medications?
What drug class is sarilumab?
Is sarilumab safe during pregnancy?
Related Medications in IL-6 Receptor Antagonist
Other drugs grouped near sarilumab — same-class peers and common alternatives.
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for sarilumab
The FDA label for sarilumab (sold under brand names such as Kevzara) classifies it as a prescription-only medication in the IL-6 Receptor Antagonist class. Kevzara treats rheumatoid arthritis (RA) in adults when other medicines have not worked well enough. Official labeling lists 8 commonly reported side effects, including Low white blood cell count (neutropenia), Increased liver enzyme levels, Redness at the injection site.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 40,317 voluntary reports. The database also lists 5 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: May 16, 2025
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages