Actemra (Tocilizumab Injection) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 22, 2012

Actemra

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Rheumatoid arthritis (RA) facts

Rheumatoid arthritis is an autoimmune disease that can cause chronic inflammation of the joints and other areas of the body.
Rheumatoid arthritis can affect people of all ages.
The cause of rheumatoid arthritis is not known.
Rheumatoid arthritis is a chronic disease, characterized by periods of disease flares and remissions.
In rheumatoid arthritis, multiple joints are usually, but not always, affected in a symmetrical pattern.
Chronic inflammation of rheumatoid arthritis can cause permanent joint destruction and deformity.
Damage to joints can occur early and does not correlate with the severity of symptoms.
The "rheumatoid factor" is an antibody that can be found in the blood of 80% of people with rheumatoid arthritis.
There is no known cure for rheumatoid arthritis.
The treatment of rheumato...

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ACTEMRA®
(tocilizumab)

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, ADVERSE REACTIONS]. 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 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].

DRUG DESCRIPTION

ACTEMRA (tocilizumab) is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody of the immunoglobulin IgG1κ (gamma 1, kappa) subclass with a typical H₂L₂ polypeptide structure. Each light chain and heavy chain consists of 214 and 448 amino acids, respectively. The four polypeptide chains are linked intra- and inter-molecularly by disulfide bonds. ACTEMRA has a molecular weight of approximately 148 kDa.

ACTEMRA is supplied as a sterile, preservative-free solution for intravenous (IV) infusion at a concentration of 20 mg per mL. ACTEMRA is a colorless to pale yellow liquid, with a pH of about 6.5. Single-use vials are available containing 80 mg per 4 mL, 200 mg per 10 mL, or 400 mg per 20 mL of ACTEMRA. Injectable solutions of ACTEMRA are formulated in an aqueous solution containing disodium phosphate dodecahydrate and sodium dihydrogen phosphate dehydrate (as a 15 mmol per L phosphate buffer), polysorbate 80 (0.5 mg per mL), and sucrose (50 mg per mL).

Last reviewed on RxList: 6/8/2011
This monograph has been modified to include the generic and brand name in many instances.