Immunologic Agents : Immunomodulators
IHUMI1 “Humira pre-filled injection” 40mg; 0.8ml/syringe
適應症：類風濕性關節炎：HUMIRA適用於患有中度至重度類風濕性關節炎並且曾經對一種或超過一種的DMARDs藥物有不適當反應的成人病患，可減輕症狀與徵兆(包括主要臨床反應和臨床緩解)、抑制結構上損害的惡化。HUMIRA可單獨使用也可以和MTX或其他DMARDs藥物併用。乾癬性關節炎：適用於對疾病緩解型抗風濕藥物無療效之成人活動性與進行性乾癬性關節炎。HUMIRA可單獨使用也可以和MTX或DMARDs藥物併用。僵直性脊椎炎：適用於減輕患有活動性僵直性脊椎炎的病患之症狀與徵兆。克隆氏症：適用於對傳統治療無效之成人中度至重度克隆氏症(CD)，可減輕症狀與徵兆及誘導與維持臨床緩解。Humira亦適用於對infliximab已經失去療效或無耐受性之成人中度至重度克隆氏症，可減輕症狀與徵兆及誘導與維持臨床緩解。乾癬：對其他全身性治療，包括cyclosporine、MTX或其他光化學療法無效、有禁忌或無法耐受之中度至重度乾癬成人患者。幼年型自發性多關節炎：Humira併用MTX適用於13至17歲患有活動性幼年型自發性多關節炎，並且曾經對一種或超過一種的DMARDs藥物反應不佳的青少年病患。Humira可單獨使用於對MTX無法耐受或不適合持續使用之患者。
Usual dose:
Rheumatoid arthritis, psoriasis with arthropathy and ankylosing spondylitis: SC 40 mg every other week. In rheumatoid arthritis patient without receiving methotrexate, dose may be increase to 40 qw.
Crohn disease: SC 160 mg on 1st day (may administer as 4 injection in 1 day or 2 injections daily for 2 consecutive days), followed by 80 mg after 2 wk, then 40 mg q2w.
Adverse effect:
Common: Injection site pain, Injection site reaction, Rash, Antibody development, to adalimumab, Antinuclear antibody positive Headache, Sinusitis , Upper respiratory infection.
Serious: Congestive heart failure, Erythema multiforme, Stevens-Johnson syndrome, Agranulocytosis , Aplastic anemia, Erythrocytosis, Leukopenia, Pancytopenia, Thrombocytopenia, Hepatic failure, Anaphylaxis, Cancer, Immune hypersensitivity reaction, T-cell lymphoma, hepatosplenic, Demyelinating disease of central nervous system, Legionella pneumonia, Tuberculosis, Infectious disease, Legionella pneumonia, Listeriosis.
健保使用規範：健保藥品給付規定第八章免疫製劑。