New FDA Approval: Tyenne® (tocilizumab-aazg) Summary
The Food and Drug Administration (FDA) has approved Tyenne® (tocilizumab-aazg), the first biosimilar to Actemra® (tocilizumab) for both intravenous (IV) and subcutaneous (SC) administration.
Check out InpharmD's summary below:
| Drug Name |
Tyenne® (tocilizumab-aazg) Injection |
| Active Ingredient |
tocilizumab-aazg (Actemra) |
| Date of Approval |
3/5/2024 |
| Manufacturer |
Fresenius Kabi |
| Approval Pathways |
BLA |
| Therapeutic Class |
Immunosuppressant |
| Formulation |
injection, for intravenous use and injection, for subcutaneous use |
| MoA |
Tocilizumab products bind to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and havebeen showntoinhibitIL-6-mediatedsignalingthroughthesereceptors.IL-6isapleiotropicpro-inflammatory cytokine produced by a variety of cell types including T- and B-cells, lymphocytes, monocytes and fibroblasts. IL-6 has been shown to be involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation. IL-6 is also produced by synovial and endothelial cells leading to local production of IL-6 in joints affected by inflammatory processes such as rheumatoid arthritis. |
| Dosing and Administration |
Intravenous Infusion
Injection: 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL),
400 mg/20 mL (20 mg/mL) in single-dose vials for further dilution prior to intravenous infusion
Subcutaneous Injection
Injection: 162 mg/0.9 mL in a single-dose prefilled syringe or single-dose prefilled autoinjector
For RA, pJIA and sJIA, Tyenne® may be used alone or in combination with methotrexate; and in RA, other DMARDs may be used.
General Administration and Dosing Information:
• RA, GCA, PJIA and SJIA – It is recommended that Tyenne® not be initiated in patients with an absolute neutrophil count (ANC) below 2000 per mm3, platelet count below 100,000 per mm3, or ALT or AST above 1.5 times the upper limit of normal (ULN).
• In RA patients, Tyenne® doses exceeding 800 mg per infusion are not recommended.
• In GCA patients, Tyenne® doses exceeding 600 mg per infusion are not recommended.
Rheumatoid Arthritis
Recommended Adult Intravenous Dosage:
When used in combination with DMARDs or as monotherapy the recommended starting dose is 4 mg per kg every 4 weeks followed by an increase to 8 mg per kg every 4 weeks based on clinical response.
Recommended Adult Subcutaneous Dosage:
• Patients less than 100 kg weight: 162 mg administered subcutaneously every other week, followed by an increase to every week based on clinical response
• Patients at or above 100 kg weight: 162 mg administered subcutaneously every week
Giant Cell Arteritis
Recommended Adult Intravenous Dosage: The recommended dose is 6 mg per kg every 4 weeks in combination with a tapering course of glucocorticoids. Tyenne® can be used alone following discontinuation of glucocorticoids.
Recommended Adult Subcutaneous Dosage: The recommended dose is 162 mg given once every week as a subcutaneous injection, in combination with a tapering course of glucocorticoids.
A dose of 162 mg given once every other week as a subcutaneous injection, in combination with a tapering course of glucocorticoids, may be prescribed based on clinical considerations.
Tyenne® can be used alone following discontinuation of glucocorticoids.
Polyarticular Juvenile Idiopathic Arthritis
Recommended Intravenous PJIA Dosage Every 4 Weeks:
• Patients less than 30 kg weight: 10 mg per kg
• Patients at or above 30 kg weight: 8 mg per kg
Recommended Subcutaneous PJIA Dosage
• Patients less than 30 kg weight: 162 mg once every three weeks
• Patients at or above 30 kg weight: 162 mg once every two weeks
Systemic Juvenile Idiopathic Arthritis
Recommended Intravenous SJIA Dosage Every 2 Weeks:
• Patients less than 30 kg weight: 12 mg per kg
• Patients at or above 30 kg weight: 8 mg per kg
Recommended Subcutaneous SJIA Dosage
• Patients less than 30 kg weight: 162 mg every two weeks
• Patients at or above 30 kg weight: 162 mg every week
Administration of Intravenous formulation
• For patients with RA, GCA, PJIA and SJIA patients at or above 30 kg, dilute to 100 mL in 0.9% or 0.45% Sodium Chloride Injection, USP for intravenous infusion using aseptic technique.
• For PJIA and SJIA patients less than 30 kg, dilute to 50 mL in 0.9% or 0.45% Sodium Chloride Injection, USP for intravenous infusion using aseptic technique.
• Administer as a single intravenous drip infusion over 1 hour; do not administer as bolus or push.
Administration of Subcutaneous formulation
• Follow the Instructions for Use for prefilled syringe and prefilled autoinjector |
| Place in Therapy |
Tyenne® is the first tocilizumab biosimilar with both IV and subcutaneous formulations approved by the FDA.
For the treatment of several inflammatory and immune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.
Tyenne® marks Fresenius Kabi's third biosimilar to receive FDA approval following the launch of STIMUFEND (pefilgrastim-fpgk) in February 2023, and IDACIO (adalilmumab-aacf) in July 2023. |
| Expected Market Launch Date |
2024-2025 |
| New Molecular Entity (NME) or Existing Formulation |
Existing Formulation/Biosimilar |
| Expected Cost |
Estimation unavailable |
| Product Discontinuation |
N/A |
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