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 infusion
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
Indications and Usage (1) 04/2011
Dosage and Administration (2) 04/2011
Contraindications (4) 04/2011
Warnings and Precautions (5.2, 5.3, 5.5, 5.6, 5.8) 04/2011
Adverse Reactions (6.1) 04/2011

 
INDICATIONS AND USAGE
ACTEMRA® (tocilizumab) is an interleukin-6 (IL-6) receptor inhibitor indicated for treatment of:

Rheumatoid Arthritis (1.1)

Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.
Systemic Juvenile Idiopathic Arthritis (SJIA) (1.2)

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.

Rheumatoid Arthritis (2.1)

Recommended Adult Dosage Every 4 Weeks
Patients who have had an inadequate response to one or more TNF antagonists When used in combination with DMARDs or as monotherapy the recommended starting dose is 4 mg per kg followed by an increase to 8 mg per kg based on clinical response.

Systemic Juvenile Idiopathic Arthritis (2.2)

Recommended 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 (2.3)

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

For adults and SJIA patients at or above 30 kg, dilute to 100 mL in 0.9% Sodium Chloride for intravenous infusion using aseptic technique.
For SJIA patients less than 30 kg, dilute to 50 mL in 0.9% Sodium Chloride for intravenous infusion using aseptic technique.
Administer as a single intravenous drip infusion over 1 hour; do not administer as bolus or push.
Dose Modifications (2.4)

Recommended for management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia.

 
DOSAGE FORMS AND STRENGTHS
Single-use vials of ACTEMRA (20 mg per mL):

80 mg per 4 mL (3)
200 mg per 10 mL (3)
400 mg per 20 mL (3)

 
CONTRAINDICATIONS
ACTEMRA should not be administered to patients with known hypersensitivity to ACTEMRA (4)