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.