ACTEMRA
Actemra (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for the treatment of several inflammatory and autoimmune conditions in adult and pediatric populations. It is used for adults with moderately to severely active rheumatoid arthritis who have not responded adequately to other disease-modifying drugs, as well as those with giant cell arteritis or systemic sclerosis-associated interstitial lung disease. The medication is also approved for juvenile idiopathic arthritis, CAR T cell-induced cytokine release syndrome, and certain hospitalized patients with COVID-19.
How ACTEMRA Works
Tocilizumab binds to both soluble and membrane-bound interleukin-6 (IL-6) receptors to inhibit IL-6-mediated signaling. IL-6 is a pro-inflammatory cytokine produced by various cell types that is involved in physiological processes such as T-cell activation, immunoglobulin secretion, and the initiation of hepatic acute phase protein synthesis. By blocking these receptors, the drug disrupts the inflammatory signaling pathways that contribute to joint damage and systemic inflammation. In conditions like rheumatoid arthritis, this action reduces the local production of IL-6 by synovial and endothelial cells.
Details
- Status
- Prescription
- First Approved
- 2010-01-08
- Routes
- INTRAVENOUS, SUBCUTANEOUS, INJECTION
- Dosage Forms
- INJECTABLE
ACTEMRA Approval History
What ACTEMRA Treats
7 indicationsACTEMRA is approved for 7 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rheumatoid Arthritis
- Giant Cell Arteritis
- Systemic Sclerosis-Associated Interstitial Lung Disease
- Polyarticular Juvenile Idiopathic Arthritis
- Systemic Juvenile Idiopathic Arthritis
- Cytokine Release Syndrome
- Coronavirus Disease 2019 (COVID-19)
ACTEMRA Boxed Warning
RISK OF SERIOUS INFECTIONS Patients treated with ACTEMRA 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 ACTEMRA until the infection is controlled. Reported infections include: Active tuberculosis, which may pres...
WARNING: RISK OF SERIOUS INFECTIONS Patients treated with ACTEMRA 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 ACTEMRA 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 ACTEMRA use and during therapy. Treatment for latent infection should be initiated prior to ACTEMRA 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 ACTEMRA 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 ACTEMRA, 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 ACTEMRA. ( 5.1 ) If a serious infection develops, interrupt ACTEMRA 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 ACTEMRA.
ACTEMRA Target & Pathway
ProTarget
A cytokine involved in inflammation and immune regulation. Elevated IL-6 drives inflammation in rheumatoid arthritis and is linked to cytokine release syndrome. Blocking IL-6 or its receptor reduces inflammatory responses in autoimmune conditions.
ACTEMRA Biosimilars
4 FDA-approved1 can be substituted at the pharmacy without calling the prescriber. The other 3 require prescriber approval to switch.
What are biosimilars? Lower-cost alternatives to ACTEMRA with no clinically meaningful differences.
Auto-substitute OK = FDA "interchangeable" designation — pharmacist can switch without calling the doctor.
ACTEMRA Competitors
Pro1 other drug also targets IL-6. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (IL-6). Earlier expiry dates signal biosimilar/generic opportunities.
Drugs Similar to ACTEMRA
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ACTEMRA FDA Label Details
ProIndications & Usage
FDA Label (PDF)ACTEMRA ® (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) 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) Adult patients with giant cell arteritis. Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) Slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) Polyarticular Juvenile Idiopat...
WARNING: RISK OF SERIOUS INFECTIONS Patients treated with ACTEMRA 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 i...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.