藥碼
BIM01
藥名
臨採事審 Bimekizumab 筆針 160 mg
英文商品名
臨採事審 Bimzelx 筆針 160 mg/ml
中文商品名
本能適注射液 160 毫克
螢幕名
臨採事審 Bimzelx 筆針 160 mg/mL
劑型
Inj
規格
成分
藥理分類
Immunosuppressive Agents
健保碼
KC01289209
ATC碼
適應症
Moderate-to-severe plaque psoriasis, active psoriatic arthritis, active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, active ankylosing spondylitis (AS), and moderate-to-severe hidradenitis suppurativa (HS) in adults.
藥理
Bimekizumab is a humanized monoclonal antibody that selectively binds and neutralizes IL-17A and IL-17F, thereby inhibiting IL-17-mediated inflammatory responses.
藥動學
Bioavailability :
approximately 70% following SC administration.
Tmax : 3–4 days.
Volume of distribution : approximately 11.2 L.
Like other monoclonal antibodies, bimekizumab is expected to be degraded into small peptides and amino acids via catabolic pathways.
Elimination :
Half life : 23 days.
Clearance: 0.337 L/day; estimated to be ~31% higher in patients with moderate to severe hidradenitis suppurativa.
Pharmacokinetics are generally similar across psoriasis, psoriatic arthritis, nr-axSpA, and AS populations.
approximately 70% following SC administration.
Tmax : 3–4 days.
Volume of distribution : approximately 11.2 L.
Like other monoclonal antibodies, bimekizumab is expected to be degraded into small peptides and amino acids via catabolic pathways.
Elimination :
Half life : 23 days.
Clearance: 0.337 L/day; estimated to be ~31% higher in patients with moderate to severe hidradenitis suppurativa.
Pharmacokinetics are generally similar across psoriasis, psoriatic arthritis, nr-axSpA, and AS populations.
禁忌症
There are no contraindications listed in the US manufacturer's labeling.
Canadian labeling: Hypersensitivity to bimekizumab or any component of the formulation.
Canadian labeling: Hypersensitivity to bimekizumab or any component of the formulation.
懷孕分類
Human data are limited. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
哺乳分類
There are no adequate data regarding the presence of bimekizumab in human milk or its effects on the breastfed infant. Consider the benefits of breastfeeding and the mother's clinical need for treatment.
副作用
Common :
upper respiratory tract infection, oral candidiasis, headache, injection-site reactions, tinea infections, gastroenteritis, and fatigue.
Serious :
serious infections, tuberculosis reactivation, liver biochemical abnormalities, inflammatory bowel disease exacerbation, and suicidal ideation/behavior.
upper respiratory tract infection, oral candidiasis, headache, injection-site reactions, tinea infections, gastroenteritis, and fatigue.
Serious :
serious infections, tuberculosis reactivation, liver biochemical abnormalities, inflammatory bowel disease exacerbation, and suicidal ideation/behavior.
劑量和給藥方法
Administration :
Subcutaneous administration only.
Allow the prefilled syringe/autoinjector to reach room temperature before injection. Administer into the thigh, abdomen, or upper arm. Rotate injection sites and avoid areas that are tender, bruised, erythematous, or affected by psoriasis lesions.
Dose :
Plaque Psoriasis :
320 mg SC at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter.
For patients 120 kg, consider 320 mg every 4 weeks after Week 16.
Psoriatic Arthritis :
160 mg SC every 4 weeks.
Patients with coexisting moderate-to-severe plaque psoriasis should receive the psoriasis regimen.
nr-axSpA : 160 mg SC every 4 weeks.
Ankylosing Spondylitis : 160 mg SC every 4 weeks.
Hidradenitis Suppurativa : 320 mg SC at Weeks 0, 2, 4, 6, 8, 10, 12, 14, and 16, then every 4 weeks thereafter.
Subcutaneous administration only.
Allow the prefilled syringe/autoinjector to reach room temperature before injection. Administer into the thigh, abdomen, or upper arm. Rotate injection sites and avoid areas that are tender, bruised, erythematous, or affected by psoriasis lesions.
Dose :
Plaque Psoriasis :
Psoriatic Arthritis :
160 mg SC every 4 weeks.
Patients with coexisting moderate-to-severe plaque psoriasis should receive the psoriasis regimen.
nr-axSpA : 160 mg SC every 4 weeks.
Ankylosing Spondylitis : 160 mg SC every 4 weeks.
Hidradenitis Suppurativa : 320 mg SC at Weeks 0, 2, 4, 6, 8, 10, 12, 14, and 16, then every 4 weeks thereafter.
小兒調整劑量
Safety and efficacy in pediatric patients have not been established.
腎功能調整劑量
No dosage adjustment required. Dedicated studies have not been conducted; clinically meaningful effects of renal impairment are not expected for monoclonal antibodies.
肝功能調整劑量
No dosage adjustment required. Dedicated studies have not been conducted; clinically meaningful effects of hepatic impairment are not expected for monoclonal antibodies.
安定性
Store refrigerated at 2–8°C in the original carton to protect from light. Do not freeze or shake.
If needed, BIMZELX may be stored at room temperature up to 25°C for a single period of up to 30 days. Once stored at room temperature, do not return to refrigeration.
If needed, BIMZELX may be stored at room temperature up to 25°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
斑塊性乾癬、乾癬性關節炎、無放射影像確認之中軸性脊椎關節炎、僵直性脊椎炎
主要副作用
上呼吸道感染、皮膚黴菌感染、口腔念珠菌感染、腸胃炎、毛囊炎
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 <冰箱>X41 | 藥庫 <冰箱>X23
藥品外觀
顏色
形狀
剝痕
標記1
標記2
其他
健保藥價
26025
自費價
29928.75
仿單
資料庫
健保給付規定
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