ADALIMUMAB (D2E7) (a-da-lim'u-mab) Humira Classifications: biologic response modifier; tumor necrosis factor modifier; disease-modifying antirheumatic drug (dmard); Therapeutic: antirheumatic agent; dmard Prototype: Etanercept Pregnancy Category: B |
40 mg/0.8 mL injection
Adalimumab is a human recombinant IgG1 monoclonal antibody. It neutralizes the effects of tumor necrosis factor (TNF)-alpha, a cytokine, by blocking its interaction with cell surface TNF receptors. This mechanism blocks the normal inflammatory and immune responses controlled by TNF-alpha. In the presence of complement, adalimumab may also lyse TNF-expressing cells.
Reduces the levels of acute phase inflammatory reactants (C-reactive protein, ESR, interleukin-6) thus decreasing overall joint inflammation; also reduces levels of enzymes that produce tissue remodeling responsible for cartilage destruction. In RA, adalimumab reduces the numerous inflammatory events of polyarthritis. It reduces the overproduction of TNF-alpha principally by macrophages in rheumatoid joints.
Treatment of moderate to severe rheumatoid arthritis or psoriatic arthritis and to reduce progression of the disease in patients with or without a disease-modifying antirheumatic drug (DMARD), treatment of Crohn's disease.
Hypersensitivity to adalimumab or mannitol; active infection, either chronic or acute; neoplastic disease; sepsis; lactation. Safe use in children has not been established.
History of recurrent infection or conditions predisposing to infection; recurrent history of sensitivity to monoclonal antibodies; cardiovascular disease; neurological disease; patients residing in areas with endemic TB or histoplasmosis; active or latent TB infection prior to therapy; demyelinating disorders; concurrent administration of immunosuppressants; surgery; pregnancy (category B).
Rheumatoid Arthritis Adult: SC 40 mg every other wk (may use 40 mg every wk if not on concomitant methotrexate) Crohn's Disease Adult: SC Initial dose of 160 mg (dose can be administered as 4 injections in 1 d or as 2 injections/d for 2 consecutive d), then 80 mg at wk 2, followed by 40 mg every other wk beginning at wk 4 |
Assessment & Drug Effects
Patient & Family Education