藥碼
ENB01
藥名
Etanercept【高】注射劑 50 mg
英文商品名
事審 Enbrel【高】注射劑 50 mg
中文商品名
恩博針筒裝注射劑
螢幕名
事審 Enbrel【高】注射劑 50 mg
劑型
Inj
規格
Etanercept 50mg/1ml/PFS
成分
藥理分類
Disease-Modifying Antirheumatic Agents
健保碼
KC00846248
ATC碼
藥品圖片
外觀圖片
適應症
活動性類風濕性關節炎、乾癬性關節炎、僵直性脊椎炎、中度至重度乾癬 Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis
藥理
Tumor Necrosis Factor (TNF) Blocking Agent
Etanercept is a dimeric soluble form of the p75 tumor necrosis factor (TNF) receptor that specifically binds TNF alpha and TNF beta, rendering TNF biologically inactive. TNF is a naturally occurring cytokine involved in normal inflammatory and immune responses, and plays an important role in the inflammatory processes of rheumatoid arthritis, polyarticular juvenile arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.
藥動學
Absorption:
Bioavailability, subQ: 58%
Distribution:
Vd: 12 L
Elimination Half Life:
102 hours
禁忌症
Sepsis or at risk of sepsis syndrome (eg, immunocompromised, HIV positive)
懷孕分類
B (FDA) B2 (AUS)
哺乳分類
Infant risk cannot be ruled out.(MDX)
副作用
Common:
Dermatologic: Injection site reaction, skin rash
Gastrointestinal: Diarrhea
Respiratory: Upper respiratory infection
Headache <20220815>

Serious:
Cardiovascular: Congestive heart failure
Dermatologic: Erythema multiforme, Malignant melanoma, Necrotizing fasciitis, Primary cutaneous vasculitis, Skin cancer, Squamous cell carcinoma of skin, Stevens-Johnson syndrome, Toxic epidermal necrolysis, Kaposi sarcoma <20220815>
Hematologic: Aplastic anemia (<0.01% ), Leukemia, Pancytopenia (<0.1% )
Hepatic: Reactivation of hepatitis B viral hepatitis (<0.01% )
Immunologic: Autoimmune hepatitis (<0.1% ), Cancer, Hepatosplenic T-cell lymphoma, Hypersensitivity reaction (<2% ), Malignant lymphoma
Neurologic: Demyelinating disease of central nervous system, Multiple sclerosis, Peripheral demyelinating neuropathy, Seizure, Transverse myelitis, acute
Ophthalmic: Optic neuritis
Respiratory: Tuberculosis (0.006% to 0.02% )
Other: Infectious disease.
劑量和給藥方法
Ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis: SubQ
  • Once-weekly dosing: 50 mg once weekly; maximum dose (rheumatoid arthritis): 50 mg/week.
  • Twice-weekly dosing (off-label dose): 25 mg twice weekly
    Plaque psoriasis:
  • Initial: 50 mg twice weekly for 3 months (starting doses of 25 or 50 mg once weekly have also been used successfully).
  • Maintenance dose: 50 mg once weekly (Some patients may require 50 mg twice weekly).
  • 小兒調整劑量
    Juvenile idiopathic arthritis (>2 years):
  • Once-weekly dosing: (subQ) 0.8 mg/kg/dose once weekly; maximum dose: 50 mg/dose
  • Twice-weekly dosing: (subQ) 0.4 mg/kg/dose twice weekly, given 72 to 96 hours apart; maximum dose: 25 mg/dose
    Kawasaki disease; acute, adjunct therapy (>2 months):
    Limited data available. (subQ) 0.8 mg/kg/dose for 3 doses; administer first dose immediately after completion of IVIG (day 0), then next 2 doses administered weekly
    Plaque psoriasis (4-17 years):
    (subQ) 0.8 mg/kg/dose once weekly; maximum dose: 50 mg/dose
  • 腎功能調整劑量
    There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
    肝功能調整劑量
    There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
    安定性
    Refrigerate at 2 to 8 degrees C . Do not freeze or shake, and protect from light in the original container.
    藥袋資訊
    臨床用途
    活動性類風濕性關節炎、乾癬性關節炎、僵直性脊椎炎、中度至重度乾癬
    主要副作用
    注射部位紅斑、搔癢、疼痛或腫脹、呼吸道感染、頭痛、發燒、過敏等
    泡製方法
    儲存方式
    請置於 2-8℃ 冷藏儲存
    注意事項
    其他說明
    門診 X5-1 | 藥庫 冰Y22 | <一盒4支>
    藥品外觀
    顏色
    形狀
    剝痕
    標記1
    標記2
    其他
    健保藥價
    6271
    自費價
    7525.2
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