Last reviewed 2026-04-20 · How we verify

Roactemra (tocilizumab)

Roactemra works by blocking the interleukin-6 receptor, a protein that plays a key role in inflammation.

Roactemra (tocilizumab) is a biologic medication developed by Genentech, targeting the interleukin-6 receptor to treat various inflammatory conditions. It is an interleukin-6 receptor antagonist, originally developed as a small molecule but later classified as a biologic due to its large molecular size. Roactemra is FDA-approved for several indications, including Castleman's disease, giant cell arteritis, and juvenile idiopathic arthritis. The medication has a half-life of 21.5 days and is currently owned by Genentech. Key safety considerations include increased risk of infections and neutropenia.

At a glance

Mechanism of action

Tocilizumab binds to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and has been shown to inhibit IL-6-mediated signaling through these receptors. IL-6 is pleiotropic pro-inflammatory cytokine produced by 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.

Approved indications

• Rheumatoid Arthritis (RA)
• Giant Cell Arteritis (GCA)
• Polyarticular Juvenile Idiopathic Arthritis (PJIA)
• Systemic Juvenile Idiopathic Arthritis (SJIA)
• Coronavirus Disease 2019 (COVID-19)

Boxed warnings

• WARNING: RISK OF SERIOUS INFECTIONS Patients treated with tocilizumab products including TOFIDENCE 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 TOFIDENCE 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 TOFIDENCE use and during therapy. Treatment for latent infection should be initiated prior to TOFIDENCE 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 TOFIDENCE 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 TOFIDENCE, 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 TOFIDENCE 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 TOFIDENCE. ( 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 infections
• Pneumonia
• Urinary tract infection
• Cellulitis
• Herpes zoster
• Gastroenteritis

Key clinical trials

• A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc) (PHASE3)
• A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis (PHASE3)
• A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid Arthritis (PHASE3)
• An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA) (PHASE3)
• A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis (PHASE3)
• A Study to Assess the Effect of Tocilizumab + Methotrexate on Prevention of Structural Joint Damage in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA) (PHASE3)
• A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors (PHASE4)
• A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis (PHASE3)

Primary sources

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Competitive intelligence

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

• Roactemra CI brief — competitive landscape report
• Roactemra updates RSS · CI watch RSS
• Roche portfolio CI