Last reviewed 2026-04-20 · How we verify

TOCILIZUMAB

At a glance

Approved indications

No approved indications tracked.

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 adverse events

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

Key clinical trials

• A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) (PHASE1, PHASE2)
• Part B- G1X-CGD (Lentiviral Vector Transduced CD34+ Cells) in Patients With X-Linked Chronic Granulomatous Disease (PHASE1, PHASE2)
• Tocilizumab in Lung Transplantation (PHASE2)
• Testing the Addition of the Immune Therapy Drugs, Tocilizumab and Atezolizumab, to Radiation Therapy for Recurrent Glioblastoma (PHASE2)
• Phase II Interventional Study Evaluating Efficacy and Safety of Secukinumab in Active Severe Takayasu Patients (PHASE2)
• Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission (NA)
• Neutralizing Interleukin (IL)-6 (PHASE2)
• ACTEMRA® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma (PHASE2)

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:

• TOCILIZUMAB CI brief — competitive landscape report
• TOCILIZUMAB updates RSS · CI watch RSS