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Updated: January 25, 2026

What Is Tyenne? Uses, Dosage, and What You Need to Know in 2026

Author

Peter Daggett

Peter Daggett

Large medication capsule with information icon and educational elements

Tyenne (tocilizumab-aazg) is an FDA-approved biosimilar to Actemra that treats rheumatoid arthritis, giant cell arteritis, and more. Here's everything patients need to know in 2026.

Tyenne (tocilizumab-aazg) is an FDA-approved biologic medication used to treat several inflammatory and autoimmune conditions. It was approved by the FDA on March 5, 2024, making it the first tocilizumab biosimilar available in both intravenous (IV) and subcutaneous (SC) formulations in the United States.

If you've just been prescribed Tyenne, or you're trying to learn more about it, this article gives you a clear, factual overview of what it is, what it treats, how it's given, and what to expect.

What Is Tyenne?

Tyenne is the brand name for tocilizumab-aazg, a biologic medication manufactured by Fresenius Kabi USA, LLC. It is a biosimilar to Actemra (tocilizumab), the original brand-name drug made by Genentech/Roche.

A biosimilar is a biologic drug that is highly similar to an already-approved biologic (the reference product) with no clinically meaningful differences in safety, purity, or potency. Tyenne met the FDA's rigorous standards to be approved as biosimilar to Actemra.

Tyenne belongs to a class of drugs called interleukin-6 (IL-6) receptor antagonists. It works by blocking a specific protein in your immune system that drives inflammation.

What Conditions Does Tyenne Treat?

Tyenne is FDA-approved for the following indications:

Rheumatoid arthritis (RA): Moderately to severely active RA in adults who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). One of the most common uses.

Giant cell arteritis (GCA): Inflammation of blood vessel walls, typically in the head and neck. Tyenne can be used alone or with glucocorticoids, and can continue after glucocorticoids are stopped.

Polyarticular juvenile idiopathic arthritis (PJIA): Active disease in patients 2 years and older.

Systemic juvenile idiopathic arthritis (SJIA): Active disease in patients 2 years and older.

Cytokine release syndrome (CRS): Severe or life-threatening CRS caused by CAR T-cell therapy. Used in adults and children 2 years and older.

COVID-19: In hospitalized adults receiving systemic corticosteroids and requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. (IV formulation only for COVID-19.)

Dosage Forms and How Tyenne Is Given

Tyenne comes in two formulation types:

IV infusion vials: Available in 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL single-dose vials (all at 20 mg/mL). Administered in a clinical setting — a rheumatologist's office, infusion center, or hospital — over 60 minutes.

SC injection: Available as a 162 mg/0.9 mL single-dose prefilled syringe or single-dose prefilled autoinjector (pen). Self-injected at home under the skin of the abdomen, thigh, or upper arm.

Typical Dosing Schedules

RA (IV): 4 mg/kg every 4 weeks, may increase to 8 mg/kg every 4 weeks based on response.

RA (SC): 162 mg every week (body weight ≥100 kg) or 162 mg every other week (body weight <100 kg), possibly increasing to weekly.

GCA (SC): 162 mg every week, alone or with a short course of glucocorticoids.

Pediatric and CRS dosing are weight-based and determined by your physician.

Is Tyenne a Generic Drug?

No — Tyenne is a biosimilar, not a generic. Generic drugs are chemically identical copies of small-molecule drugs. Biologics like Tyenne are large, complex proteins made from living cells, and cannot be exactly replicated — only made to be "highly similar" (biosimilar). The FDA applies rigorous standards to confirm that biosimilars have no clinically meaningful differences from their reference drugs.

Is Tyenne a Controlled Substance?

No. Tyenne is not a controlled substance and has no DEA scheduling. It is a prescription drug requiring a doctor's order and insurance prior authorization, but there are no special restrictions on the number of refills or prescriber registration requirements associated with controlled substances.

Storage and Handling

Tyenne must be refrigerated at 36°F to 46°F (2°C to 8°C). Do not freeze. A single prefilled syringe or autoinjector may be stored at room temperature (at or below 77°F/25°C) for a single period of up to 14 days. Keep in the original carton to protect from light.

Having trouble filling your Tyenne prescription? medfinder contacts specialty pharmacies near you to find which ones can fill your Tyenne order — saving you hours of calling around.

Want to understand the science? Read: How Does Tyenne Work? Mechanism of Action Explained in Plain English.

Frequently Asked Questions

Tyenne (tocilizumab-aazg) is FDA-approved for moderately to severely active rheumatoid arthritis in adults, giant cell arteritis in adults, polyarticular juvenile idiopathic arthritis (PJIA) in patients ≥2 years, systemic juvenile idiopathic arthritis (SJIA) in patients ≥2 years, cytokine release syndrome (CRS), and COVID-19 in hospitalized adults requiring respiratory support.

Tyenne (tocilizumab-aazg) is a biosimilar to Actemra (tocilizumab), meaning it is highly similar with no clinically meaningful differences in safety, purity, or potency. However, Tyenne does not have all of Actemra's indications — Actemra is also approved for SSc-ILD, which Tyenne is not. They require separate prescriptions and are not automatically interchangeable.

Tyenne is available as IV infusion vials (80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL) for clinic administration, and as a 162 mg/0.9 mL subcutaneous prefilled syringe or autoinjector for home self-injection. The formulation used depends on your condition, dosing requirements, and your doctor's prescription.

No. Tyenne is not a controlled substance and has no DEA scheduling. It is a prescription specialty biologic that requires prior authorization from insurance, but there are no restrictions on refills or prescriber requirements associated with controlled substances.

Tyenne (tocilizumab-aazg) received FDA approval on March 5, 2024. Fresenius Kabi launched the IV formulation on April 15, 2024, making it the first Actemra biosimilar to commercially launch in the U.S. The subcutaneous formulation launched on July 2, 2024.

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