藥碼
SOT01
藥名
Deucravacitinib 6 mg
英文商品名
Sotyktu 錠 6 mg
中文商品名
舒停復膜衣錠6毫克
螢幕名
Sotyktu 錠 6 mg
劑型
Tab
規格
成分
藥理分類
健保碼
BC28554100
ATC碼
藥品圖片
外觀圖片
適應症
Moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
藥理
Deucravacitinib is a selective, allosteric tyrosine kinase 2 (TYK2) inhibitor. It binds to the regulatory domain of TYK2 and stabilizes an inhibitory interaction between the regulatory and catalytic domains, thereby inhibiting TYK2-mediated activation of STAT signaling. It modulates cytokine pathways involving IL-12, IL-23, and type I interferons.
藥動學
  • Absolute oral bioavailability is approximately 99%; median Tmax is 2 to 3 hours.
  • The apparent volume of distribution is 140 L, and protein binding is 82% to 90%.
  • The terminal half-life is approximately 10 hours.
  • Deucravacitinib is primarily metabolized by CYP1A2 and, to a lesser extent, by CYP2B6, CYP2D6, CES2, and UGT1A9.
  • Food does not cause clinically significant pharmacokinetic changes.
  • 禁忌症
    Serious hypersensitivity to deucravacitinib or any component of the formulation.
    懷孕分類
    No formal pregnancy category is assigned.
    Available human data are insufficient to establish a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Use during pregnancy only when the anticipated benefit justifies the potential risk.
    哺乳分類
    It is unknown whether deucravacitinib is present in human milk, affects the breastfed infant, or affects milk production.
    Consider the developmental and health benefits of breastfeeding, the mother's clinical need for treatment, and potential adverse effects on the breastfed infant.
    副作用
    Upper respiratory infections (19.2%), increased blood creatine phosphokinase (2.7%), herpes simplex (2%), mouth ulcers (1.9%), folliculitis (1.7%), and acne (1.4%).

    Serious or clinically important reactions include serious infections, tuberculosis, herpes virus reactivation, malignancy including lymphoma, rhabdomyolysis, elevated liver enzymes, and hypersensitivity reactions.
    劑量和給藥方法
    6 mg orally once daily, with or without food. Swallow the tablet whole; do not crush, cut, or chew. Avoid use with other potent immunosuppressants.
    小兒調整劑量
    Safety and effectiveness have not been established in pediatric patients younger than 18 years.
    腎功能調整劑量
    No dosage adjustment is recommended for mild, moderate, or severe renal impairment, including end-stage renal disease in patients receiving dialysis.
    肝功能調整劑量
    No dosage adjustment is recommended for mild or moderate hepatic impairment (Child-Pugh A or B). Use is not recommended in severe hepatic impairment (Child-Pugh C).
    安定性
    Store at 20°C to 25°C; excursions permitted between 15°C and 30°C. Keep in the original container and protect from moisture.
    藥袋資訊
    臨床用途
    治療適合全身性療法或光照療法的中度至重度成人斑塊型乾癬
    主要副作用
    上呼吸道感染、單純皰疹、口腔潰瘍、毛囊炎、痤瘡等
    泡製方法
    儲存方式
    請置於 15-30℃ 乾燥處儲存
    注意事項
    其他說明
    藥局 Y2 | 藥庫 口G21
    藥品外觀
    顏色
    19
    形狀
    02
    剝痕
    N
    標記1
    BMS 895
    標記2
    6 mg
    其他
    健保藥價
    396
    自費價
    526.68
    仿單
    資料庫
    健保給付規定