FDA approved Tyenne (tocilizumab-aazg) for Multiple Inflammatory ConditionsFDA approved new biosimilar drug Tyenne for arthritis and other conditions.

FDA From the archive Source published March 5, 2024 Summary added May 22, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

AI-generated summary of the cited source, checked by automated accuracy review. How we work

Key Takeaway

Consider Tyenne as a biosimilar option for IL-6 receptor antagonism across multiple inflammatory indications.

The FDA has approved Tyenne (tocilizumab-aazg), a biosimilar to tocilizumab, for the treatment of several inflammatory conditions. The approval covers adult patients with moderately to severely active rheumatoid arthritis after inadequate response to DMARDs, giant cell arteritis, active polyarticular and systemic juvenile idiopathic arthritis in patients aged 2 years and older, CAR T cell-induced severe or life-threatening cytokine release syndrome, and hospitalized adults with COVID-19 requiring supplemental oxygen or ventilation. Tyenne is an interleukin-6 receptor antagonist and can be administered intravenously or subcutaneously depending on the indication. This approval provides an additional treatment option for these conditions.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Tyenne (tocilizumab-aazg) is an interleukin-6 (IL-6) receptor antagonist. It binds to both soluble and membrane-bound IL-6 receptors, inhibiting IL-6-mediated signaling.

Indication & Patient Population

Tyenne is indicated for: - Rheumatoid Arthritis (RA): Adult patients with moderately to severely active RA who have had an inadequate response to one or more DMARDs. - Giant Cell Arteritis (GCA): Adult patients with GCA. - Polyarticular Juvenile Idiopathic Arthritis (PJIA): Patients 2 years and older with active PJIA. - Systemic Juvenile Idiopathic Arthritis (SJIA): Patients 2 years and older with active SJIA. - Cytokine Release Syndrome (CRS): Adults and pediatric patients 2 years and older with CAR T cell-induced severe or life-threatening CRS. - Coronavirus Disease 2019 (COVID-19): Hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.

Dosing & Administration

General: For RA, PJIA, and SJIA, Tyenne may be used alone or with methotrexate; in RA, other non-biologic DMARDs may be used. Do not initiate if ANC <2000/mm3, platelets <100,000/mm3, or ALT/AST >1.5x ULN (for RA, GCA, PJIA, SJIA); for COVID-19, do not initiate if ANC <1000/mm3, platelets <50,000/mm3, or ALT/AST >10x ULN. Doses exceeding 800 mg per infusion are not recommended for RA, CRS, or COVID-19; for GCA, doses exceeding 600 mg per infusion are not recommended.

RA: IV: 4 mg/kg every 4 weeks, increase to 8 mg/kg based on response. SC: <100 kg: 162 mg every other week, increase to every week; ≥100 kg: 162 mg every week.

GCA: IV: 6 mg/kg every 4 weeks with glucocorticoid taper. SC: 162 mg every week (or every other week based on clinical considerations) with glucocorticoid taper.

PJIA: IV: <30 kg: 10 mg/kg; ≥30 kg: 8 mg/kg every 4 weeks. SC: <30 kg: 162 mg every 3 weeks; ≥30 kg: 162 mg every 2 weeks.

SJIA: IV: <30 kg: 12 mg/kg; ≥30 kg: 8 mg/kg every 2 weeks. SC: <30 kg: 162 mg every 2 weeks; ≥30 kg: 162 mg every week.

CRS: IV: <30 kg: 12 mg/kg; ≥30 kg: 8 mg/kg. Alone or with corticosteroids.

COVID-19: IV: 8 mg/kg as a 60-minute infusion.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Tyenne is a biosimilar to tocilizumab, providing an alternative for the treatment of multiple IL-6-mediated inflammatory conditions. It is indicated for RA, GCA, PJIA, SJIA, CRS, and COVID-19.

The FDA has approved a new drug called Tyenne (tocilizumab-aazg) for treating several inflammatory conditions. Tyenne is a biosimilar, which means it is highly similar to an already approved biologic drug (tocilizumab) and works the same way. It blocks a protein called interleukin-6 that causes inflammation in the body.

Tyenne is approved for adults with moderately to severely active rheumatoid arthritis who have not responded well to other treatments. It is also approved for giant cell arteritis, a type of blood vessel inflammation. For children ages 2 and older, it can treat active polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. Additionally, Tyenne is approved for severe cytokine release syndrome caused by CAR T cell therapy and for hospitalized adults with COVID-19 who need extra oxygen or a ventilator.

The drug can be given as an intravenous infusion or as an injection under the skin, depending on the condition being treated. This approval provides another option for patients with these serious conditions. However, like all medicines, Tyenne has potential side effects and may not be suitable for everyone.

If you or a loved one has one of these conditions, talk to your doctor about whether Tyenne might be a good choice for you. Your doctor can help you understand the benefits and risks based on your personal health situation.

What this means for you:

Tyenne is a new biosimilar option for several inflammatory conditions; talk to your doctor to see if it fits your treatment plan.

Study Details

Study typeFda approval

PublishedMar 2024

View Original Abstract ↓

1 INDICATIONS AND USAGE TYENNE ® (tocilizumab-aazg) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) ( 1.1 ) • 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) ( 1.2 ) • Adult patients with giant cell arteritis. Polyarticular Juvenile Idiopathic Arthritis (PJIA) ( 1.3 ) • Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis. Systemic Juvenile Idiopathic Arthritis (SJIA) ( 1.4 ) • Patients 2 years of age and older with active systemic juvenile idiopathic arthritis. Cytokine Release Syndrome (CRS) ( 1.5 ) • Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome. Coronavirus Disease 2019 (COVID-19) ( 1.6 ) • Hospitalized adult patients with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). 1.1 Rheumatoid Arthritis (RA) TYENNE ® (tocilizumab-aazg) is indicated for the treatment of 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). 1.2 Giant Cell Arteritis (GCA) TYENNE ® (tocilizumab-aazg) is indicated for the treatment of giant cell arteritis (GCA) in adult patients. 1.3 Polyarticular Juvenile Idiopathic Arthritis (PJIA) TYENNE ® (tocilizumab-aazg) is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. 1.4 Systemic Juvenile Idiopathic Arthritis (SJIA) TYENNE ® (tocilizumab-aazg) is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. 1.5 Cytokine Release Syndrome (CRS) TYENNE ® (tocilizumab-aazg) is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older. 1.6 Coronavirus Disease 2019 (COVID-19) TYENNE ® (tocilizumab-aazg) is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

FDA approved Tyenne (tocilizumab-aazg) for Multiple Inflammatory ConditionsFDA approved new biosimilar drug Tyenne for arthritis and other conditions.

Study Details

Evaluating the Efficacy of Traditional Chinese Medicine Decoctions for Rheumatoid Arthritis Management

Traditional Chinese medicine decoctions may improve rheumatoid arthritis symptoms

Clinical research that matters. Delivered to your inbox.

FDA approved Tyenne (tocilizumab-aazg) for Multiple Inflammatory ConditionsFDA approved new biosimilar drug Tyenne for arthritis and other conditions.

Study Details

Evaluating the Efficacy of Traditional Chinese Medicine Decoctions for Rheumatoid Arthritis Management

Traditional Chinese medicine decoctions may improve rheumatoid arthritis symptoms

Clinical research that matters. Delivered to your inbox.

Related in Rheumatology

From Other Specialties