藥碼
STE10
藥名
Ustekinumab 130 mg/26 mL
英文商品名
臨採事審 Stelara 針 130 mg/26 mL
中文商品名
喜達諾靜脈注射液 130 mg/26 mL
螢幕名
臨採事審 Stelara 針 130 mg/26 mL
劑型
Inj
規格
成分
藥理分類
Immunosuppressive Agents
健保碼
KC01084241
ATC碼
適應症
1. Moderate-to-severe plaque psoriasis in adults and pediatric patients ≥ 6 years who are candidates for phototherapy or systemic therapy
2. active psoriatic arthritis in adults and pediatric patients ≥ 6 years
3. moderately-to-severely active Crohn's disease in adults and pediatric patients ≥ 2 years
4. moderately-to-severely active ulcerative colitis in adults.
2. active psoriatic arthritis in adults and pediatric patients ≥ 6 years
3. moderately-to-severely active Crohn's disease in adults and pediatric patients ≥ 2 years
4. moderately-to-severely active ulcerative colitis in adults.
藥理
Ustekinumab is a human interleukin-12 (IL-12) and interleukin-23 (IL-23) antagonist. It binds to the p40 subunit shared by IL-12 and IL-23, preventing interaction with the IL-12Rβ1 receptor and inhibiting IL-12/IL-23-mediated signaling and inflammation.
藥動學
Distribution :
Volume of distribution at steady state approximately 4.4–4.6 L.
Metabolism :
Expected to be degraded into small peptides and amino acids through catabolic pathways similar to endogenous IgG.
Elimination :
Clearance approximately 0.19 L/day in patients with Crohn's disease or ulcerative colitis; terminal half-life approximately 19 days in these populations.
Volume of distribution at steady state approximately 4.4–4.6 L.
Metabolism :
Expected to be degraded into small peptides and amino acids through catabolic pathways similar to endogenous IgG.
Elimination :
Clearance approximately 0.19 L/day in patients with Crohn's disease or ulcerative colitis; terminal half-life approximately 19 days in these populations.
禁忌症
Clinically significant hypersensitivity to ustekinumab or any of the excipients.
懷孕分類
Available data have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Ustekinumab may cross the placenta, particularly during the third trimester. Use during pregnancy should consider the potential benefits and risks.
哺乳分類
Limited published data suggest that ustekinumab is present in human milk. No adverse effects causally related to ustekinumab have been identified in breastfed infants. Consider the benefits of breastfeeding together with the mother's clinical need for treatment and potential effects on the infant.
副作用
Common :
nasopharyngitis, upper respiratory tract infection, headache, fatigue, injection-site erythema, vomiting, pruritus, sinusitis, bronchitis, urinary tract infection, nausea, abdominal pain, diarrhea, and fever.
Serious :
serious infections, hypersensitivity reactions including anaphylaxis, malignancy, and noninfectious pneumonia.
Rare cases of posterior reversible encephalopathy syndrome (PRES) have also been reported.
nasopharyngitis, upper respiratory tract infection, headache, fatigue, injection-site erythema, vomiting, pruritus, sinusitis, bronchitis, urinary tract infection, nausea, abdominal pain, diarrhea, and fever.
Serious :
serious infections, hypersensitivity reactions including anaphylaxis, malignancy, and noninfectious pneumonia.
Rare cases of posterior reversible encephalopathy syndrome (PRES) have also been reported.
劑量和給藥方法
Plaque psoriasis (Adults) :
≤100 kg: 45 mg SC at Weeks 0 and 4, then every 12 weeks >100 kg: 90 mg SC at Weeks 0 and 4, then every 12 weeks.
Psoriatic arthritis (Adults) :
45 mg SC at Weeks 0 and 4, then every 12 weeks; 90 mg may be used in patients >100 kg with coexistent moderate-to-severe plaque psoriasis.
Crohn's disease / Ulcerative colitis (Adults) :
single weight-based IV induction dose (≤55 kg: 260 mg; >55–85 kg: 390 mg; >85 kg: 520 mg), followed by 90 mg SC at Week 8 and every 8 weeks thereafter.
Administration :
Subcutaneous : Administer into the upper arms, buttocks, thighs, or abdomen; avoid areas of tender, bruised, erythematous, or indurated skin.
IV induction : For Crohn's disease and ulcerative colitis, dilute the calculated dose in 0.9% Sodium Chloride Injection and administer over at least 1 hour using an in-line sterile, non-pyrogenic, low-protein-binding 0.2-micrometer filter. Do not administer concomitantly through the same IV line with other agents.
Psoriatic arthritis (Adults) :
45 mg SC at Weeks 0 and 4, then every 12 weeks; 90 mg may be used in patients >100 kg with coexistent moderate-to-severe plaque psoriasis.
Crohn's disease / Ulcerative colitis (Adults) :
single weight-based IV induction dose (≤55 kg: 260 mg; >55–85 kg: 390 mg; >85 kg: 520 mg), followed by 90 mg SC at Week 8 and every 8 weeks thereafter.
Administration :
Subcutaneous : Administer into the upper arms, buttocks, thighs, or abdomen; avoid areas of tender, bruised, erythematous, or indurated skin.
IV induction : For Crohn's disease and ulcerative colitis, dilute the calculated dose in 0.9% Sodium Chloride Injection and administer over at least 1 hour using an in-line sterile, non-pyrogenic, low-protein-binding 0.2-micrometer filter. Do not administer concomitantly through the same IV line with other agents.
小兒調整劑量
Plaque psoriasis / Psoriatic arthritis (≥ 6 years) :
<60 kg: 0.75 mg/kg SC
60–100 kg: 45 mg SC
>100 kg: 90 mg SC when coexistent moderate-to-severe plaque psoriasis is present.
Administer at Weeks 0 and 4, then every 12 weeks.
Crohn's disease (≥ 2 years) :
IV induction:
10–25 kg: 10 mg/kg
>25–55 kg: 260 mg
>55–85 kg: 390 mg
>85 kg: 520 mg.
Maintenance :
10–35 kg: 2.5 mg/kg SC at Week 8, then every 8 weeks
>35 kg: 90 mg SC at Week 8, then every 8 weeks.
Administer at Weeks 0 and 4, then every 12 weeks.
Crohn's disease (≥ 2 years) :
IV induction:
腎功能調整劑量
No dosage adjustment required. Pharmacokinetics are not expected to be significantly affected by renal impairment.
肝功能調整劑量
No dosage adjustment required. Pharmacokinetics are not expected to be significantly affected by hepatic impairment.
安定性
Store vials and prefilled syringes at 2–8°C in the original carton and protect from light. Do not freeze or shake.
Individual prefilled syringes may be stored at room temperature 30°C for a single period of up to 30 days; once stored at room temperature, do not return to refrigeration.
Individual prefilled syringes may be stored at room temperature 30°C for a single period of up to 30 days; once stored at room temperature, do not return to refrigeration.
藥袋資訊
臨床用途
克隆氏症、潰瘍性結腸炎
主要副作用
下呼吸道感染、頭痛、疲倦、暈眩、肌肉痛、注射部位紅斑、咽喉疼痛
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 不備庫 |藥庫 冰X11
藥品外觀
顏色
形狀
剝痕
標記1
標記2
其他
健保藥價
40887
自費價
47020.05
仿單
資料庫
健保給付規定
## 資料使用與著作權聲明 本網站提供之藥品資訊，主要供醫療照護、藥事服務、衛教及一般資訊查詢使用。網站內容包含藥品名稱、成分、劑型、規格、適應症、使用方式、劑量、注意事項及其他相關資訊，實際內容依各藥品資料來源及本院資料建置情形而定。 一、醫療使用聲明 本網站所提供之藥品資訊僅供參考，不應單獨作為診斷、治療、處方調整、停藥或自行用藥之依據。 藥品之實際適應症、使用方法、使用劑量、使用頻率、療程及相關注意事項，應依個別病人之病情、年齡、肝腎功能、合併用藥及其他臨床狀況，由醫師或其他具資格之醫療專業人員進行專業判斷。 病人實際使用藥品時，請以醫師處方、藥袋標示及醫療專業人員之指示為依歸。請勿僅依本網站資訊自行增加、減少、停止或改變藥品使用方式及劑量。 如網站資訊與醫師處方、藥袋標示或醫療專業人員指示有所不同，應優先依醫師處方及醫療專業人員之個別指示使用。 二、資料來源與更新 本網站藥品資訊參考藥品資訊資料庫、主管機關核准之藥品仿單、藥品許可證資料、藥品製造或供應廠商提供之資料、本院藥品管理資料，以及其他經評估之專業資訊來源。 藥品資訊可能因主管機關核准內容、藥品許可證、仿單、供應狀況或臨床建議更新而有所變動，本網站將依實際作業情形進行維護與更新。 如需確認最新藥品核准資訊，應以主管機關公告、最新版藥品仿單及醫療專業人員判斷為準。 三、資料使用範圍 本網站內容可供個人查詢、醫療照護、衛教及非商業性學習使用。 使用者引用或轉載本網站內容時，應註明資料來源，並保留原有內容之完整性及必要之醫療警語，不得任意變更、變更原意或其他可能造成錯誤醫療理解之方式使用。 未經授權，不得將本網站內容大量重製、建立資料庫、進行商業性再利用，或以其他方式侵害相關著作權或其他權利。 四、著作權及第三方資料 本網站由本院自行製作之文字、編排、圖表、圖示及其他內容，其著作權或相關權利依著作權法及其他相關法令受到保護。 網站中引用之藥品仿單、藥品圖片、商標、產品名稱、主管機關資料或其他第三方資料，其著作權、商標權或其他相關權利仍歸原權利人所有。 本網站對第三方資料之使用，以醫療資訊提供、教育、研究或其他合法使用目的為原則，相關權利仍應依原資料來源及相關法令辦理。 五、責任範圍 本網站致力於維持資料之正確性與完整性，但藥品資訊可能隨核准事項、臨床資訊及供應狀況變更。 使用者因個別疾病、用藥或治療問題需要醫療判斷時，應洽詢醫師、藥師或其他適當之醫療專業人員。 本網站提供之一般性藥品資訊，無法取代醫療專業人員依個別病人狀況所作之醫療評估、處方及用藥指導。 六、聲明內容之調整 本院得依相關法令、資料來源、網站功能及實際作業需要，適時修訂本聲明內容。