TOFIDENCE
TOFIDENCE (tocilizumab-bavi) is an interleukin-6 (IL-6) receptor antagonist indicated for the treatment of several chronic inflammatory and autoimmune conditions in adult and pediatric populations. It is used for adults with moderately to severely active rheumatoid arthritis who have not responded adequately to disease-modifying anti-rheumatic drugs, as well as for adults with giant cell arteritis. The medication is also approved for patients aged two and older with active polyarticular or systemic juvenile idiopathic arthritis. Additionally, it is indicated for hospitalized adults with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
How TOFIDENCE Works
TOFIDENCE functions by binding to both soluble and membrane-bound interleukin-6 (IL-6) receptors, which inhibits IL-6-mediated signaling. IL-6 is a pro-inflammatory cytokine involved in various 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 pathways that lead to local IL-6 production in joints and other tissues. This inhibition helps manage the stimulation of hematopoietic precursor cells and other drivers of systemic inflammation.
Details
- Status
- Prescription
- First Approved
- 2023-09-29
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
TOFIDENCE Approval History
What TOFIDENCE Treats
5 indicationsTOFIDENCE is approved for 5 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rheumatoid Arthritis
- Giant Cell Arteritis
- Polyarticular Juvenile Idiopathic Arthritis
- Systemic Juvenile Idiopathic Arthritis
- Coronavirus Disease 2019
TOFIDENCE Boxed Warning
RISK OF SERIOUS INFECTIONS Patients treated with tocilizumab products including TOFIDENCE 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 TOFIDENCE until the infection is controlled. Reported infections include: A...
WARNING: RISK OF SERIOUS INFECTIONS Patients treated with tocilizumab products including TOFIDENCE 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 TOFIDENCE 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 TOFIDENCE use and during therapy. Treatment for latent infection should be initiated prior to TOFIDENCE 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 TOFIDENCE 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 TOFIDENCE, 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 TOFIDENCE until the infection is controlled. ( 5.1 ) Perform test for latent TB (except patients with COVID-19); if posi
TOFIDENCE 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.
TOFIDENCE is a lower-cost alternative to Actemra with no clinically meaningful differences. Requires prescriber approval to substitute.
TOFIDENCE 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 TOFIDENCE
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.
TOFIDENCE FDA Label Details
ProIndications & Usage
FDA Label (PDF)TOFIDENCE™ (tocilizumab-bavi) 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 ac...
WARNING: RISK OF SERIOUS INFECTIONS Patients treated with tocilizumab products including TOFIDENCE 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 infe...
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.