Immunologic Agents : Immunomodulators
IENBR3 “Enbrel pre-filled injection” 50 mg/syringe
適應症：適用於對疾病緩解型抗風濕性藥物(即DMARDs，例如methotrexate) 無適當療效之成人活動性類風濕性關節炎。也適用於先前未使用methotrexate治療之成人中度至重度活動性類風濕性關節炎。這些病人的X光檢查顯示，本品可以減緩疾病造成的關節結構性受損。亦適用於methotrexate治療無效或無法耐受的4歲以上兒童及青少年的活動性多關節幼年型慢性關節炎。尚未對4歲以下的兒童進行試驗。適用於對疾病緩解型抗風濕性藥物無療效之成人活動性與進行性乾癬性關節炎。治療活動性僵直性脊椎炎。適用於對其他全身性治療(包括cyclosporine、methotrexate 或光化療法(PUVA) )無效、有禁忌或無法耐受之中度至重度乾癬成人患者。適用於對其他全身性治療或光化療法無法有效控制或無法耐受之8歲以上兒童及青少年的重度乾癬。
Usual dose:
Ankylosing spondylitis: 50 mg SC weekly given as one 50 mg injection or two 25 mg injections in one day, or one 25 mg injection given twice weekly, 72-96 h apart.
Plaque psoriasis, chronic (moderate to severe), in p’ts who are candidates for systemic therapy or phototherapy: initial, 50 mg SC twice weekly, given 3-4 days apart, for 3 mon; maintenance, 50 mg SC weekly, given as one injection via prefilled syringe.
Psoriasis with arthropathy, Rheumatoid arthritis: 50 mg SC weekly given as one 50 mg injection or two 25 mg injections in one day, or one 25 mg injection given twice weekly, 72 -96 h apart.
Adverse effect:
Common: injection site reaction, abdominal pain, vomiting, headache, rhinitis.
Serious: basal cell carcinoma of skin, erythema multiforme, necrotizing fasciitis, primary cutaneous vasculitis, squamous cell carcinoma of skin, Stevens-Johnson syndrome, toxic epidermal necrolysis due to drug, anemia, aplastic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, autoimmune hepatitis, autoimmune hepatitis, immune hypersensitivity reaction, infectious disease, malignant lymphoma, tuberculosis, multiple sclerosis, optic neuritis, tuberculosis, cancer.
健保使用規範：健保藥品給付規定第八章免疫製劑。