HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ACTEMRA safely and effectively. See full prescribing information for ACTEMRA.
ACTEMRA(tocilizumab) injection, for intravenous use
injection, for subcutaneous use
Initial U.S. Approval: 2010
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; if positive, start treatment for TB prior to starting ACTEMRA. (5.1)
Monitor all patients for active TB during treatment, even if initial latent TB test is negative. (5.1)
RECENT MAJOR CHANGES
Dosage and Administration (2.5) (3/2017)
INDICATIONS AND USAGE
ACTEMRA® (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of:
Rheumatoid Arthritis (RA) (1.1)
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).
Polyarticular Juvenile Idiopathic Arthritis (PJIA) (1.2)
Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.
Systemic Juvenile Idiopathic Arthritis (SJIA) (1.3)
Patients 2 years of age and older with active systemic juvenile idiopathic arthritis.
DOSAGE AND ADMINISTRATION
ACTEMRA may be used alone or in combination with methotrexate: and in RA, other DMARDs may be used. (2)
Rheumatoid Arthritis (2.1)
Recommended Adult Intravenous (IV) Dosage:
When used in combination with DMARDs or as monotherapy the recommended starting dose is 4 mg per kg every 4 weeks followed by an increase to 8 mg per kg every 4 weeks based on clinical response.
Recommended Adult Subcutaneous (SC) Dosage:
Patients less than 100 kg weight 
162 mg administered subcutaneously every other week, followed by an increase to every week based on clinical response
Patients at or above 100 kg weight 
162 mg administered subcutaneously every week
Polyarticular Juvenile Idiopathic Arthritis (2.2)
Recommended Intravenous PJIA Dosage Every 4 Weeks
Patients less than 30 kg weight 10 mg per kg
Patients at or above 30 kg weight 8 mg per kg
Systemic Juvenile Idiopathic Arthritis (2.3)
Recommended Intravenous SJIA Dosage Every 2 Weeks
Patients less than 30 kg weight 12 mg per kg
Patients at or above 30 kg weight 8 mg per kg
General Dosing Information (2.4)
It is recommended that ACTEMRA not be initiated in patients with an absolute neutrophil count (ANC) below 2000 per mm3, platelet count below 100,000 per mm3, or who have ALT or AST above 1.5 times the upper limit of normal (ULN). (2.1, 5.3)
ACTEMRA doses exceeding 800 mg per infusion are not recommended in RA patients. (2.1, 12.3)
Administration of Intravenous formulation (2.5)
For adults, PJIA and SJIA patients at or above 30 kg, dilute to 100 mL in 0.9% or 0.45% Sodium Chloride for intravenous infusion using aseptic technique.
For PJIA and SJIA patients less than 30 kg, dilute to 50 mL in 0.9% or 0.45% Sodium Chloride for intravenous infusion using aseptic technique.
Admin