藥碼
TRU04
藥名
臨採 Capivasertib 錠 200 mg
英文商品名
臨採事審 Truqap 錠 200 mg
中文商品名
泛抑癌膜衣錠200毫克
螢幕名
臨採事審 Truqap 錠 200 mg
劑型
Tab
規格
成分
藥理分類
Antineoplastic Drugs
健保碼
BC28820100
ATC碼
適應症
1. HR-positive, HER2-negative, locally advanced or metastatic breast cancer with PIK3CA, AKT1, or PTEN alterations, in combination with fulvestrant.
2. PTEN-deficient metastatic prostate cancer, in combination with abiraterone and prednisone.
2. PTEN-deficient metastatic prostate cancer, in combination with abiraterone and prednisone.
藥理
Capivasertib is an oral AKT inhibitor that inhibits all three isoforms of serine/threonine kinase AKT (AKT1, AKT2, and AKT3) and inhibits phosphorylation of downstream AKT substrates. The AKT pathway may be activated by PIK3CA mutations, AKT1 mutations, or loss of PTEN function. Inhibition of AKT signaling suppresses tumor cell proliferation and survival.
藥動學
Absorption :
Tmax approximately 1–2 hours; absolute bioavailability approximately 29%. Food does not have a clinically meaningful effect on exposure.
Distribution :
Steady-state oral volume of distribution approximately 1,847 L; plasma protein binding approximately 78%.
Metabolism :
Primarily metabolized by CYP3A4 and UGT2B7.
Elimination :
Terminal half-life approximately 8.3 hours; steady-state oral clearance approximately 50 L/hr. Approximately 21% of total clearance is renal. Following a single radiolabeled dose, approximately 45% was recovered in urine and 50% in feces.
Tmax approximately 1–2 hours; absolute bioavailability approximately 29%. Food does not have a clinically meaningful effect on exposure.
Distribution :
Steady-state oral volume of distribution approximately 1,847 L; plasma protein binding approximately 78%.
Metabolism :
Primarily metabolized by CYP3A4 and UGT2B7.
Elimination :
Terminal half-life approximately 8.3 hours; steady-state oral clearance approximately 50 L/hr. Approximately 21% of total clearance is renal. Following a single radiolabeled dose, approximately 45% was recovered in urine and 50% in feces.
禁忌症
Severe hypersensitivity to capivasertib or any of its components.
懷孕分類
No adequate human pregnancy data are available.
Verify pregnancy status before initiation in females of reproductive potential. Effective contraception is recommended during treatment and for 1 month after the last dose in females of reproductive potential; male patients with female partners of reproductive potential should use effective contraception during treatment and for 4 months after the last dose.
Verify pregnancy status before initiation in females of reproductive potential. Effective contraception is recommended during treatment and for 1 month after the last dose in females of reproductive potential; male patients with female partners of reproductive potential should use effective contraception during treatment and for 4 months after the last dose.
哺乳分類
There are no data regarding the presence of capivasertib or its metabolites in human milk or their effects on the breastfed infant or milk production. Because of the potential for serious adverse reactions in a breastfed child, breastfeeding is not recommended during treatment with TRUQAP.
副作用
severe hyperglycemia, including diabetic ketoacidosis; severe diarrhea; and severe cutaneous adverse reactions, including erythema multiforme, palmar-plantar erythrodysesthesia, and DRESS(Drug Reaction with Eosinophilia and Systemic Symptoms).
劑量和給藥方法
Breast cancer :
In combination with fulvestrant, 400 mg orally twice daily (approximately 12 hours apart), with or without food, for 4 consecutive days followed by 3 days off each week. Continue until disease progression or unacceptable toxicity.
Prostate cancer :
1. In combination with abiraterone and prednisone, 400 mg orally twice daily (approximately 12 hours apart), with or without food, for 4 days followed by 3 days off each week.
2. Patients with mAPMN/S prostate cancer should also receive a GnRH analog concurrently or have undergone bilateral orchiectomy.
Administration
1. Swallow tablets whole with water; do not chew, crush, or split tablets. May be administered with or without food.
2. If a dose is missed by 4 hours, take the missed dose; if >4 hours have elapsed, skip the missed dose and take the next dose at the usual time.
3. If vomiting occurs after a dose, do not take an additional dose; take the next dose at the usual scheduled time.
In combination with fulvestrant, 400 mg orally twice daily (approximately 12 hours apart), with or without food, for 4 consecutive days followed by 3 days off each week. Continue until disease progression or unacceptable toxicity.
Prostate cancer :
1. In combination with abiraterone and prednisone, 400 mg orally twice daily (approximately 12 hours apart), with or without food, for 4 days followed by 3 days off each week.
2. Patients with mAPMN/S prostate cancer should also receive a GnRH analog concurrently or have undergone bilateral orchiectomy.
Administration
1. Swallow tablets whole with water; do not chew, crush, or split tablets. May be administered with or without food.
2. If a dose is missed by 4 hours, take the missed dose; if >4 hours have elapsed, skip the missed dose and take the next dose at the usual time.
3. If vomiting occurs after a dose, do not take an additional dose; take the next dose at the usual scheduled time.
小兒調整劑量
Not established. Safety and effectiveness in pediatric patients have not been established.
腎功能調整劑量
肝功能調整劑量
No dosage adjustment is necessary.
There are no dosage adjustments provided in the manufacturer's labeling (effect is not fully characterized). Capivasertib exposure may be increased; monitor for adverse reactions.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
安定性
Store at 20–25°C.
藥袋資訊
臨床用途
局部晚期或轉移性乳癌成人
主要副作用
尿道感染、貧血、高血糖、食慾減退、頭痛、腹瀉、噁心嘔吐、搔癢
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 不備庫 | 藥庫 口管G
藥品外觀
顏色
06
形狀
03
剝痕
N
標記1
CAV200
標記2
其他
健保藥價
2070
自費價
2484
仿單
資料庫
健保給付規定
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