AVTOZMA
AVTOZMA (tocilizumab-anoh) is an interleukin-6 (IL-6) receptor antagonist indicated for the treatment of several inflammatory and autoimmune conditions in adult and pediatric populations. It is used for adults with moderate-to-severe rheumatoid arthritis who have had an inadequate response to DMARDs, as well as adults with giant cell arteritis. The medication is also approved for patients aged two and older with polyarticular or systemic juvenile idiopathic arthritis and those experiencing severe or life-threatening CAR T cell-induced cytokine release syndrome. Furthermore, it is indicated for hospitalized adults with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
How AVTOZMA Works
AVTOZMA functions by binding to both soluble and membrane-bound interleukin-6 (IL-6) receptors. This binding inhibits IL-6-mediated signaling, which is a primary driver of various pro-inflammatory physiological processes. IL-6 is a cytokine involved in T-cell activation, immunoglobulin secretion, and the initiation of hepatic acute phase protein synthesis. By blocking these receptors, the drug reduces the inflammatory activity produced by synovial and endothelial cells in affected joints and other tissues.
Details
- Status
- Prescription
- First Approved
- 2025-01-24
- Routes
- INTRAVENOUS, SUBCUTANEOUS, IV (INFUSION)
- Dosage Forms
- INJECTABLE
AVTOZMA Approval History
What AVTOZMA Treats
6 indicationsAVTOZMA is approved for 6 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rheumatoid Arthritis
- Giant Cell Arteritis
- Polyarticular Juvenile Idiopathic Arthritis
- Systemic Juvenile Idiopathic Arthritis
- Cytokine Release Syndrome
- Coronavirus Disease 2019
AVTOZMA Boxed Warning
RISK OF SERIOUS INFECTIONS Patients treated with tocilizumab products including AVTOZMA 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) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt AVTOZMA until the infection is controlled. Reported infections include: Acti...
WARNING: RISK OF SERIOUS INFECTIONS Patients treated with tocilizumab products including AVTOZMA 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) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt AVTOZMA until the infection is controlled. Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients, except those with COVID-19, should be tested for latent tuberculosis before AVTOZMA use and during therapy. Treatment for latent infection should be initiated prior to AVTOZMA use. Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. Bacterial, viral and other infections due to opportunistic pathogens. The risks and benefits of treatment with AVTOZMA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with AVTOZMA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy [see Warnings and Precautions (5.1) ] . WARNING: RISK OF SERIOUS INFECTIONS See full prescribing information for complete boxed warning. Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic infections have occurred in patients receiving tocilizumab products. ( 5.1 ) If a serious infection develops, interrupt AVTOZMA until the infection is controlled. ( 5.1 ) Perform test for latent TB (except patients with COVID-19); if positive, start
AVTOZMA 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.
Pharmacists can substitute AVTOZMA for Actemra without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.
AVTOZMA 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 AVTOZMA
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.
AVTOZMA FDA Label Details
ProIndications & Usage
FDA Label (PDF)AVTOZMA ® (tocilizumab-anoh) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). Giant Cell Arteritis (GCA) Adult patients with giant cell arteritis. Polyarticular Juvenile Idiopathic Arthritis (PJIA) Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis. Systemic Juvenile Idiopathic Arthritis (SJIA) Patients 2 years of age and older with act...
WARNING: RISK OF SERIOUS INFECTIONS Patients treated with tocilizumab products including AVTOZMA 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) ] . Most patients who developed these infec...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.