TYENNE (tocilizumab-aazg) · Fresenius Kabi
TYENNE (tocilizumab-aazg) is an interleukin-6 (IL-6) receptor antagonist indicated for the treatment of several chronic inflammatory conditions, including rheumatoid arthritis in adults with an inadequate response to disease-modifying anti-rheumatic drugs and giant cell arteritis. It is also used in pediatric patients aged two and older for polyarticular and systemic juvenile idiopathic arthritis, as well as for severe or life-threatening cytokine release syndrome induced by CAR T cell therapy. Furthermore, the medication is indicated for hospitalized adults with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
How TYENNE Works
TYENNE 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 that plays a role in diverse physiological processes, including T-cell activation, the secretion of immunoglobulins, and the initiation of hepatic protein synthesis. By blocking these receptors, the drug interferes with the inflammatory signaling pathways involved in the progression of diseases like rheumatoid arthritis.
Details
- Status
- Prescription
- First Approved
- 2024-03-05
- Routes
- INTRAVENOUS, SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
TYENNE Approval History
What TYENNE Treats
6 indicationsTYENNE is approved for 6 conditions since its original approval in 2024. 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
TYENNE Boxed Warning
RISK OF SERIOUS INFECTIONS Patients treated with tocilizumab products including TYENNE 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 TYENNE until the infection is controlled. Reported infections include: • Ac...
WARNING: RISK OF SERIOUS INFECTIONS Patients treated with tocilizumab products including TYENNE 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 TYENNE 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 TYENNE use and during therapy. Treatment for latent infection should be initiated prior to TYENNE 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 TYENNE 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 TYENNE 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 TYENNE until the infection is controlled. ( 5.1 ) • Perform test for latent TB (except patients with COVID-19); if positive,
TYENNE 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.
TYENNE is a lower-cost alternative to Actemra with no clinically meaningful differences. Requires prescriber approval to substitute.
TYENNE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in TYENNE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TYENNE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TYENNE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Fresenius Kabi's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07570173 | 1045-005 MK-1045-005, 2025-522267-15-00 | Ph 2, Ph 3 | recruiting | A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005) |
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.
TYENNE FDA Label Details
Indications & Usage
FDA Label (PDF)TYENNE ® (tocilizumab-aazg) 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 w...
WARNING: RISK OF SERIOUS INFECTIONS Patients treated with tocilizumab products including TYENNE 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...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.