藥碼
LUM03
藥名
事審 Brodalumab 皮下針 210 mg/PFS
英文商品名
事審 Lumicef 皮下針 210 mg/PFS
中文商品名
立美西膚皮下注射劑210毫克
螢幕名
事審 Lumicef 皮下針 210 mg/PFS
劑型
Inj
規格
Brodalumab 210mg/pfs
成分
藥理分類
Immunosuppressive Agents
健保碼
KC010762DA
ATC碼
藥品圖片
外觀圖片
適應症
1. 斑塊性乾癬:Moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.
2. 膿泡性乾癬:Pustular psoriasis in adult patients for systemic therapy.
3. 乾癬性關節炎:Psoriatic arthriti patients who have failed to respond or resistant to disease-modifying antirheumatic drug(DMARD) <20210122>
4. 活動性僵直性脊椎炎 <20220721>
#仿單變更2021 #仿單變更2022
藥理
Anti-interleukin 17-Receptor Antibody; Antipsoriatic Agent; Monoclonal Antibody
藥動學
Distribution: Vd: 8.9 ± 9.4 L
Metabolism: Degraded into small peptides in a manner similar to endogenous IgG
Bioavailability: SubQ: ~55%
Time to peak: ~3 days
Excretion: Clearance: Mean (±SD) apparent total clearance (CL/F) of a 210 mg subcutaneous dose was 3.0 ± 3.5 L/day
禁忌症
Crohn disease (In some studies, exacerbation of Crohn disease was observed with brodalumab)
懷孕分類
1. The lowest exposure would be expected during the period of organogenesis.
2. The American Academy of Dermatology considers brodalumab for the treatment of psoriasis to be likely acceptable for use in male patients planning to father a child (AAD-NPF [Menter 2019]).
哺乳分類
It is not known if brodalumab is present in breast milk.(Should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.)
副作用
Infection (25%; including bronchitis, nasopharyngitis, pharyngitis, upper respiratory tract infection, urinary tract infection), suicidal ideation, neutropenia, antibody development <20210122>
劑量和給藥方法
SubQ: 210 mg at weeks 0, 1, and 2, followed by 210 mg once every 2 weeks.
Consider discontinuing if an adequate response is not achieved after 12 to 16 weeks (continuing treatment beyond 16 weeks in patients without an adequate response is not likely to result in greater success).
小兒調整劑量
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
藥袋資訊
臨床用途
中、重度斑塊性乾癬成人、膿?性乾癬成人
主要副作用
關節痛、頭痛、鼻咽炎、上呼吸道感染、精神不穩
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 X5-4 | 藥庫 冰Y23
藥品外觀
顏色
形狀
剝痕
標記1
標記2
其他
健保藥價
13008
自費價
14959.2
仿單
資料庫
健保給付規定