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)
INDICATIONS AND USAGE
ACTEMRA® (tocilizumab) is an interleukin-6 (IL-6) receptor inhibitor indicated for treatment of:
Rheumatoid Arthritis (1)
Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.
DOSAGE AND ADMINISTRATION
Rheumatoid Arthritis (2.1)
ACTEMRA may be used alone or in combination with methotrexate or other DMARDs.
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/kg followed by an increase to 8 mg/kg based on clinical response. 
It is recommended that ACTEMRA not be initiated in patients with an absolute neutrophil count (ANC) below 2000/mm3, platelet count below 100,000/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. (2.1, 12.3)
Administration (2.2)
Dilute to 100 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 (2.3)
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/mL):
80 mg/ 4 mL (3)
200 mg/ 10 mL (3)
400 mg/ 20 mL (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
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. (5.1)
Gastrointestinal (GI) perforation – use with caution in patients who may be at increased risk. (5.2)
Laboratory monitoring – recommended due to potential consequences of treatment-related changes in neutrophils, platelets, lipids, and liver function tests. (2.3, 5.3)
Anaphylaxis or serious hypersensitivity reactions have occurred. (5.5)
Live vaccines – should not be given with ACTEMRA. (5.8, 7.3)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch