KEVZARA
Kevzara (sarilumab) is an interleukin-6 (IL-6) receptor antagonist indicated for the treatment of several chronic inflammatory conditions. It is used in 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). The medication is also approved for adults with polymyalgia rheumatica who are resistant to or cannot tolerate corticosteroids, as well as for patients weighing 63 kg or greater with active polyarticular juvenile idiopathic arthritis.
How KEVZARA Works
Sarilumab binds to both soluble and membrane-bound interleukin-6 (IL-6) receptors, effectively inhibiting IL-6-mediated signaling. IL-6 is a pro-inflammatory cytokine involved in diverse physiological processes, including T-cell activation, immunoglobulin secretion, and the initiation of hepatic acute phase protein synthesis. By blocking these receptors, the drug interferes with the inflammatory signaling produced by synovial and endothelial cells in joints affected by inflammatory processes.
Details
- Status
- Prescription
- First Approved
- 2017-05-22
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
KEVZARA Approval History
What KEVZARA Treats
3 indicationsKEVZARA is approved for 3 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rheumatoid Arthritis
- Polymyalgia Rheumatica
- Polyarticular Juvenile Idiopathic Arthritis
KEVZARA Boxed Warning
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 infection...
WARNING: 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. WARNING: RISK OF SERIOUS INFECTIONS See full prescribing information for complete boxed warning . Serious infections leading to hospitalization or death including bacterial, viral, invasive fungal, and other opportunistic infections have occurred in patients receiving KEVZARA. ( 5.1 ) If a serious infection develops, interrupt KEVZARA until the infection is controlled. ( 5.1 ) Cases of tuberculosis (TB) have been reported. Prior to starting KEVZARA, test for latent TB; if positive, start treatment for TB. ( 5.1 ) Closely monitor patients for signs and symptoms of infection during treatment with KEVZARA. ( 5.1 )
KEVZARA Target & Pathway
ProTarget
A cytokine involved in inflammation and immune regulation. Elevated IL-6 drives inflammation in rheumatoid arthritis and is linked to cytokine release syndrome. Blocking IL-6 or its receptor reduces inflammatory responses in autoimmune conditions.
KEVZARA Competitors
Pro1 other drug also targets IL-6. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (IL-6). Earlier expiry dates signal biosimilar/generic opportunities.
Drugs Similar to KEVZARA
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
KEVZARA FDA Label Details
ProIndications & Usage
FDA Label (PDF)KEVZARA ® 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). adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). 1.1 Rheumatoid Arthritis (RA) KEVZARA ® is indicated for treatment of adult ...
WARNING: 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 ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.