藥碼
SOL08
藥名
事審 Eculizumab 罕病 針 300 mg
英文商品名
事審 Soliris 罕病 針 300 mg
中文商品名
舒立瑞 濃縮靜脈輸注液 300毫克
螢幕名
事審 Soliris 罕病 針 300 mg
劑型
Inj
規格
成分
藥理分類
健保碼
YC00016243
ATC碼
藥品圖片
外觀圖片
適應症
Atypical hemolytic uremic syndrome: Treatment of atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy.
Generalized myasthenia gravis, refractory: Treatment of refractory generalized myasthenia gravis in adults who are antiacetylcholine receptor antibody positive.
Neuromyelitis optica spectrum disorder: Treatment of neuromyelitis optica spectrum disorder in adults who are aquaporin-4-antibody positive.
Paroxysmal nocturnal hemoglobinuria: Treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis
藥理
Monoclonal Antibody; Monoclonal Antibody, Complement Inhibitor
藥動學
Onset of action: PNH: Reduced hemolysis: ?1 week
Distribution: 5 to 8 L
Half-life elimination: ~270 to 414 hours (during plasma exchange the half-life is reduced to 1.26 hours)
禁忌症
Unresolved serious Neisseria meningitidis infection; patients not currently vaccinated against Neisseria meningitidis
懷孕分類
Available data, although limited, do not suggest safety concerns when eculizumab is used during pregnancy.
哺乳分類
Eculizumab may be 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 benefits of treatment to the mother.
副作用
Cardiovascular: Hypertension , tachycardia, peripheral edema, hypotension

Central nervous system: Headache, insomnia, fatigue, dizziness

Dermatologic: Skin rash, pruritus)
Endocrine & metabolic: Hypokalemia

Gastrointestinal: Diarrhea, vomiting, nausea, abdominal pain, gastroenteritis

Genitourinary: Urinary tract infection, urinary tract symptoms, proteinuria

Hematologic & oncologic: Anemia, neoplasm, leukopenia

Infection: Infection, influenza

Local: Catheter infection

Neuromuscular & skeletal: Asthenia, back pain, arthralgia, musculoskeletal pain, muscle spasm

Ophthalmic: Eye disease

Renal: Renal insufficiency

Respiratory: Cough, nasopharyngitis, nasal congestion, upper respiratory tract infection, rhinitis, bronchitis

Miscellaneous: Fever
劑量和給藥方法
Atypical hemolytic uremic syndrome: IV: Induction: 900 mg weekly for 4 doses; Maintenance: 1,200 mg at week 5, then 1,200 mg every 2 weeks thereafter.
Generalized myasthenia gravis, refractory: IV: Induction: 900 mg weekly for 4 doses; Maintenance: 1,200 mg at week 5, then 1,200 mg every 2 weeks thereafter.
Neuromyelitis optica spectrum disorder: IV: Induction: 900 mg weekly for 4 doses; Maintenance: 1,200 mg at week 5, then 1,200 mg every 2 weeks thereafter.
Paroxysmal nocturnal hemoglobinuria: IV: Induction: 600 mg weekly for 4 doses; Maintenance: 900 mg at week 5; then 900 mg every 2 weeks thereafter.
小兒調整劑量
Atypical hemolytic uremic syndrome (aHUS): Infants, Children, and Adolescents:
Patient weight:
5 kg to <10 kg: IV: Induction: 300 mg weekly for 1 dose; Maintenance: 300 mg at week 2, then 300 mg every 3 weeks.
10 kg to <20 kg: IV: Induction: 600 mg weekly for 1 dose; Maintenance: 300 mg at week 2, then 300 mg every 2 weeks.
20 kg to <30 kg: IV: Induction: 600 mg weekly for 2 doses; Maintenance: 600 mg at week 3, then 600 mg every 2 weeks.
30 kg to <40 kg: IV: Induction: 600 mg weekly for 2 doses; Maintenance: 900 mg at week 3, then 900 mg every 2 weeks.
?40 kg: Induction: IV: 900 mg weekly for 4 doses; Maintenance: 1,200 mg at week 5, then 1,200 mg every 2 weeks.
腎功能調整劑量
There are no dosage adjustments provided in the manufacturer's labeling
肝功能調整劑量
There are no dosage adjustments provided in the manufacturer's labeling
安定性
藥袋資訊
臨床用途
治療陣發性夜間血紅素尿症(PNH)、非典型溶血性尿毒症候群(aHUS)
主要副作用
過敏、發燒、寒顫、噁心、嘔吐頭痛
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
本品為 事審藥品,藥局不備庫存,請至藥庫調藥 藥庫 冰X13
藥品外觀
顏色
形狀
剝痕
標記1
標記2
其他
健保藥價
122130
自費價
134343
仿單
資料庫
健保給付規定