藥碼
NUC02
藥名
Mepolizumab 針 100 mg/mL/Syr
英文商品名
事審 Nucala 充填針 100 mg/mL/Syr
中文商品名
舒肺樂注射劑100毫克/毫升
螢幕名
事審 Nucala 針 100 mg/mL/Syr
劑型
Inj
規格
Mepolizumab 100mg/vial
成分
藥理分類
Misc. Respiratory Tract Agents
健保碼
KC01144209
ATC碼
藥品圖片
外觀圖片
適應症
1. Granulomatosis with polyangiitis, Eosinophilic.
2. Severe asthma, Add-on maintenance in patients with eosinophilic phenotype.
藥理
Interleukin-5 Antagonist Monoclonal Antibody
Mepolizumab is an interleukin-5 (IL-5) antagonist monoclonal antibody that reduces the production and survival of eosinophils
藥動學
Absorption
Bioavailability, subQ: 80%
Distribution
Vd: 3.6 L
Metabolism
Body-wide proteolytic enzymes
Excretion
Total body clearance: 0.28 L/day
Half Life:
16 to 22 days
禁忌症
Hypersensitivity to mepolizumab or any ingredient in the product
懷孕分類
Fetal risk cannot be ruled out (cross placenta)
哺乳分類
Use of monoclonal antibodies for the treatment of asthma in lactating women may be considered when conventional therapies are insufficient; use of an agent other than mepolizumab may be preferred
副作用
Common
Dermatologic: Injection site reaction (Asthma, 8% ; Eosinophilic granulomatosis with polyangiitis, 15%)
Immunologic: Antibody development
Musculoskeletal: Backache
Neurologic: Headache
Other: Fatigue
Serious
Immunologic: Herpes zoster, Hypersensitivity reaction, Systemic
劑量和給藥方法
Eosinophilic granulomatosis with polyangiitis(EGPA), Hypereosinophilic syndrome(HES):
300 mg subQ (given as 3 separate 100-mg injections at least 5 cm apart in the upper arm, thigh, or abdomen) once every 4 weeks
Chronic rhinosinusitis with nasal polyps(CRSwNP):
100 mg subQ once every 4 weeks injected into the upper arm, thigh or abdomen.
<20230927>

Severe asthma, Add-on maintenance in patients with eosinophilic phenotype:
100 mg subQ once every 4 weeks injected into the upper arm, thigh or abdomen.
小兒調整劑量
Severe asthma, Add-on maintenance in patients with eosinophilic phenotype:
(≥12 years old) 100 mg subQ once Q4W injected into the upper arm, thigh or abdomen.
(6-11 years old) 40 mg subQ once Q4W injected into the upper arm, thigh or abdomen.<20230927>
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
1. Store vial in below 25 degrees C. Do not freeze and protect from light.
2. After reconstitution, use immediately or store below 30 degrees C; do not freeze.
3. Discard if not used within 8 hours of reconstitution.
藥袋資訊
臨床用途
嗜伊紅性白血球的嚴重氣喘且控制不良之成人患者
主要副作用
過敏反應、注射部位疼痛、腫脹、紅斑、搔癢、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
門診 X5-3 | 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
28781
自費價
33098.15
仿單
資料庫
健保給付規定