藥碼
BEN04
藥名
臨採 Belimumab 針 400 mg/Vial
英文商品名
臨採事審 Benlysta 針 400 mg/Vial
中文商品名
奔麗生凍晶注射劑
螢幕名
臨採事審 Benlysta 針 400 mg/Vial
劑型
Inj
規格
成分
藥理分類
健保碼
KC00935271
ATC碼
藥品圖片
外觀圖片
適應症
Lupus nephritis: Treatment of adults and pediatric patients 5 years of age with active lupus nephritis who are receiving standard therapy.
Systemic lupus erythematosus: Treatment of adults and pediatric patients 5 years of age with active systemic lupus erythematosus (SLE) who are receiving standard therapy.
藥理
IgG1-lambda monoclonal antibody
Belimumab prevents the survival of B lymphocytes by blocking the binding of soluble human B lymphocyte stimulator protein (BLyS) to receptors on B lymphocytes. This reduces the activity of B-cell mediated immunity and the autoimmune response.
藥動學
  • Onset of action: B cells: 8 weeks; Clinical improvement (SLE Responder Index and flare reduction): 16 weeks (Navarra 2011).
  • Bioavailability: SUBQ: 74%.
  • Distribution: Vd: 5 L.
  • Half-life elimination: Terminal: IV: 19.4 days; SUBQ: 18.3 days.
  • Time to peak: SUBQ: 2.6 days.
  • 禁忌症
    Hypersensitivity (anaphylaxis) to belimumab or any component of the formulation
    懷孕分類
    C; Belimumab crosses the placenta. Belimumab is not currently recommended for the treatment of rheumatic and musculoskeletal diseases during pregnancy.
    哺乳分類
    Belimumab is present in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
    副作用
    Gastrointestinal: Diarrhea (12%), nausea (15%)
    Hypersensitivity: Hypersensitivity reaction (13%; including anaphylaxis, angioedema), infusion-related reaction (17%)
    Infection: Infection (71% to 82%; including influenza [>5%], sinusitis [>5%], upper respiratory tract infection [>5%], urinary tract infection [>5%]; serious infection: 6%; including cellulitis, pneumonia)
    Nervous system: Psychiatric disturbance (16%; serious: 1%; including anxiety [4%], depression [5% to 6%], insomnia [6% to 7%], suicidal ideation [[1%], suicidal tendencies [[1%])
    劑量和給藥方法
    Lupus nephritis :
    Initial: 10 mg/kg every 2 weeks for 3 doses; Maintenance: 10 mg/kg every 4 weeks.
    Systemic lupus erythematosus:
    Initial: 10 mg/kg every 2 weeks for 3 doses; Maintenance: 10 mg/kg every 4 weeks.
    小兒調整劑量
    腎功能調整劑量
    No dosage adjustment necessary.
    肝功能調整劑量
    No dosage adjustment necessary.
    安定性
  • Prior to reconstitution, store unused vials between 2°C and 8°C; do not freeze. Protect from light. Avoid exposure to heat.
  • Prior to further dilution in NS, 0.45% NS, or lactated Ringer's, the reconstituted solution must be stored under refrigeration and protected from direct sunlight.
  • The diluted solution may be stored refrigerated or at room temperature. Infusion must be completed within 8 hours of reconstitution.
  • 藥袋資訊
    臨床用途
    全身性紅斑性狼瘡
    主要副作用
    細菌感染、腹瀉、噁心、過敏、偏頭痛
    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
    藥局 <冰箱>X52 | 藥庫 冰X12
    藥品外觀
    顏色
    形狀
    剝痕
    標記1
    標記2
    其他
    健保藥價
    11960
    自費價
    13754
    仿單
    資料庫
    健保給付規定