Tocilizumab binds to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL6R), and has been shown to inhibit IL-6 mediated signaling through these receptors. IL-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including Tand 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.

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 Idiopathic Arthritis (PJIA) 

Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.

Systemic Juvenile Idiopathic Arthritis (SJIA) 

Patients 2 years of age and older with active systemic juvenile idiopathic arthritis.

Cytokine Release Syndrome (CRS) 

Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cellinduced severe or life-threatening cytokine release syndrome.

Coronavirus Disease 2019 (COVID-19) 

Hospitalized adult patients with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)

For RA, pJIA and sJIA, ACTEMRA may be used alone or in combination with methotrexate: and in RA, other DMARDs may be used. 

General Administration and Dosing Information 

RA, GCA, SSc-ILD, PJIA and SJIA – It is recommended that ACTEMRA not be initiated in patients with an absolute neutrophil count (ANC) below 2000 per mm , platelet count below 100,000 per mm , or ALT or AST above 1.5 times the upper limit of normal (ULN).

COVID-19 – It is recommended that ACTEMRA not be initiated in patients with an absolute neutrophil count (ANC) below 1000 per mm , platelet count below 50,000 mm , or ALT or AST above 10 times ULN.

In RA, CRS or COVID-19 patients, ACTEMRA doses exceeding 800 mg per infusion are not recommended. 

In GCA patients, ACTEMRA doses exceeding 600 mg per infusion are not recommended. 

See package insert for complete information.

Most common adverse reactions (incidence of at least 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, injection site reactions.

ACTEMRA is contraindicated in patients with known hypersensitivity to ACTEMRA.

• Serious Infections – do not administer ACTEMRA during an active infection, including localized infections.
• If a serious infection develops, interrupt ACTEMRA until the infection is controlled. 
• Gastrointestinal (GI) perforation—use with caution in patients who may be at increased risk. 
• Hepatotoxicity- Monitor patients for signs and symptoms of hepatic injury. Modify or discontinue ACTEMRA if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.
• Laboratory monitoring—recommended due to potential consequences of treatment-related changes in neutrophils, platelets, lipids, and liver function tests.
• Hypersensitivity reactions, including anaphylaxis and death have occurred. Live vaccines—Avoid use with ACTEMRA.