Last reviewed 2026-05-27 · How we verify

TYENNE (TOCILIZUMAB-AAZG)

TYENNE (generic name: TOCILIZUMAB-AAZG) is a Interleukin-6 Receptor Antagonist [EPC] drug developed by FRESENIUS KABI USA. It is currently FDA-approved.

TYENNE (tocilizumab-aazg) is an interleukin-6 receptor alpha subunit inhibitor, classified as an INHIBITOR drug modality, and is being studied for various conditions including Aneurysmal Subarachnoid Hemorrhage, Delayed Cerebral Ischemia, Sepsis, Neuroinflammatory Response, and Immunosuppression. TYENNE is an antibody that targets the interleukin-6 receptor subunit alpha.

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• 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, start treatment for TB prior to starting TYENNE. ( 5.1 ) • Monitor all patients for active TB during treatment, even if initial latent TB test is negative. ( 5.1 )

Common side effects

• Upper respiratory tract infections
• Nasopharyngitis
• Headache
• Hypertension
• Increased ALT
• Injection site reactions

Serious adverse events

• Serious infections
• Pneumonia
• Urinary tract infection
• Cellulitis
• Herpes zoster
• Gastroenteritis
• Diverticulitis
• Sepsis
• Bacterial arthritis
• Opportunistic infections

Key clinical trials

• THRIVE: Tocilizumab-aazg for Hemorrhage: Reduction of Ischemic Vascular Events (Phase 1)
• Immunomodulatory Effects of Dexamethasone, Tocilizumab and Anakinra During Experimental Human Endotoxemia (Phase 4)
• A Multinational, Prospective, Non-interventional Study, to Assess Real World Use of a Tocilizumab Biosimilar in Rheumatoid Arthritis Patients (N/A)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• TYENNE CI brief — competitive landscape report
• TYENNE updates RSS · CI watch RSS
• FRESENIUS KABI USA portfolio CI

Frequently asked questions about TYENNE

Related

• Drug class: All Interleukin-6 Receptor Antagonist [EPC] drugs
• Manufacturer: FRESENIUS KABI USA — full pipeline
• Therapeutic area: All drugs in Other