GENERIC NAME: tocilizumab

BRAND NAME: Actemra

DRUG CLASS AND MECHANISM: Tocilizumab is an injectable synthetic (man-made) protein that binds to interleukin-6 (IL-6) in the body and blocks the effects of IL-6 in patients with rheumatoid arthritis. Inflammation is the body's reaction to injury and is a necessary process for the repair of injury. IL-6 is a protein that the body produces when there is inflammation. IL-6 promotes inflammation and the signs of inflammation, which, in the case of arthritis, includes fever as well as pain, tenderness, and swelling of the joints. The unchecked inflammation of rheumatoid arthritis eventually leads to destruction of the joints. Tocilizumab binds to IL-6 in the body and thereby blocks the effects of IL-6. As a result, inflammation and its consequences in the joints are reduced, and the progressive destruction of the joints is slowed or prevented. The FDA approved tocilizumab in January 2010.

GENERIC AVAILABLE: No

PRESCRIPTION: Yes

PREPARATIONS: Injection: 20 mg/ml

STORAGE: Tocilizumab should be stored refrigerated at 2 to 8 C (36 to 46 F).

PRESCRIBED FOR: Tocilizumab is used for treating adult patients with moderate to severe rheumatoid arthritis who have not adequately responded to one or more TNFα blockers (for example, adalimumab [Humira], certolizumab [Cimzia]). It may be used alone or combined with methotrexate (Rheumatrex, Trexall) or other disease-modifying antirheumatic drugs. DOSING: The recommended dose of tocilizumab is 4-8 mg/kg administered as a single 60 minute intravenous infusion every 4 weeks.

DRUG INTERACTIONS: Tocilizumab has not been studied in combination with other similar drugs that block other chemicals that promote inflammation, for example, drugs that block TNF (for example, adalimumab [Humira]). Combining anakinra (Kineret), abatacept (Orencia), rituximab (Rituxan) with other antirheumatic drugs similar to tocilizumab resulted in a reduction in white blood cells in the blood (neutropenia), serious infections and no additional benefit. Tocilizumab may interfere with the effectiveness of vaccines. Live vaccines, including attenuated vaccines, should not be given to patients receiving tocilizumab.

PREGNANCY: There are no adequate studies of tocilizumab in pregnant women.

NURSING MOTHERS: It is not known whether tocilizumab is excreted in breast milk.

SIDE EFFECTS: The most common adverse effects of tocilizumab in clinical studies were respiratory tract infections, headaches, hypertension (high blood pressure), and elevations in liver tests suggesting liver injury. Injection site reactions (rash, redness, swelling, itching) may also occur. Use of tocilizumab has been associated with serious infections such as tuberculosis, sepsis (bacteria in the blood) and fungal infections. Individuals with active infections should not be treated with tocilizumab. Tocilizumab may worsen or cause new diseases of the nervous system. In studies, some patients who used tocilizumab developed cancer. Other side effects include reduced levels of white blood cells or platelets, reactivation of herpes zoster infection (shingles), and hypersensitivity (allergic) reactions. In studies, gastrointestinal perforation was observed in patients with diverticulitis.

REFERENCE: FDA prescribing information for Actemra