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藥碼
TAF03
藥名
Dabrafenib 膠囊 75 mg
英文商品名
臨採 Tafinlar 膠囊 75 mg
中文商品名
泰伏樂膠囊 75 毫克
螢幕名
臨採 Tafinlar 膠囊 75 mg
劑型
Cap
規格
Dabrafenib 75mg
成分
藥理分類
Antineoplastic Drugs
健保碼
BC26579100
ATC碼
L01EC02
藥品圖片
外觀圖片
適應症
【藥品庫存】
本藥品為臨時採購藥品，經院長核可後，限定特定科別、病人使用。

  • Melanoma:
    Treatment of unresectable or metastatic melanoma in patients with a BRAF V600E mutation (single agent therapy) or in patients with BRAF V600E or BRAF V600K mutations (in combination with trametinib).
    Confirm BRAF V600E or BRAF V600K mutation status with an approved test prior to treatment.
  • Non-small cell lung cancer, metastatic:
    Treatment of metastatic non-small cell lung cancer (NSCLC) in patients with BRAF V600E mutation (in combination with trametinib).
  • Thyroid cancer, anaplastic, locally advanced or metastatic: Treatment of locally advanced or metastatic anaplastic thyroid cancer (ATC) (in combination with trametinib) in patients with BRAF V600E mutation and with no satisfactory locoregional treatment options.

    Note: Not indicated for treatment of wild-type BRAF melanoma, wild-type BRAF NSCLC, or wild-type BRAF ATC.
    • 藥理
    Antineoplastic Agent, BRAF Kinase Inhibitor: BRAF V600 mutations result in constitutive activation of the BRAF pathway; through BRAF inhibition, dabrafenib inhibits tumor cell growth.
    Note: The combination of dabrafenib and trametinib allows for greater inhibition of the MAPK pathway and has been reported to synergistically inhibit cell growth in lung cancer cell lines which are BRAF V600E-mutant.
    藥動學
    Absorption: Decreased with a high-fat meal
    Distribution: 70.3 L
    Protein binding: 99.7% to plasma proteins
    Metabolism: Hepatic via CYP2C8 and CYP3A4 to hydroxy-dabrafenib (active) which is further metabolized via CYP3A4 oxidation to desmethyl-dabrafenib (active)
    Bioavailability: 95%.
    Half-life elimination: Parent drug: 8 hours; Hydroxy-dabrafenib (active metabolite): 10 hours; Desmethyl-dabrafenib (active metabolite): 21 to 22 hours; Carboxy-dabrafenib (21 to 22 hours).
    Time to peak: 2 hours; delayed with a high-fat meal
    Excretion: Feces (71%); urine (23%; metabolites only)
    禁忌症
    Hypersensitivity to dabrafenib or any component of the formulation.
    懷孕分類
    Based on its mechanism of action and on findings in animal reproduction studies, in utero exposure to dabrafenib may cause fetal harm
    哺乳分類
    Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended during dabrafenib treatment and for 2 weeks after the last dabrafenib dose.
    副作用
  • Common(>10%): Alopecia, hyperkeratosis, palmar-plantar erythrodysesthesia, skin rash, xeroderma, hyperglycemia, hyponatremia, hypophosphatemia, constipation, papilloma, squamous cell carcinoma of skin, increased ALT, chills, headache, arthralgia, back pain, myalgia, cough, fever
  • Postmarketing: Kaposi's sarcoma
    • 劑量和給藥方法
  • Melanoma:
    1. Adjuvant treatment (with BRAF V600E or BRAF V600K mutation): 150 mg twice daily, approximately every 12 hours (in combination with trametinib); continue for up to 1 year in the absence of disease recurrence or unacceptable toxicity.
    2. Metastatic or unresectable (with BRAF V600E mutation): 150 mg twice daily, approximately every 12 hours (single-agent therapy); continue until disease progression or unacceptable toxicity.
    3. Metastatic or unresectable (with BRAF V600E or BRAF V600K mutation): 150 mg twice daily, approximately every 12 hours (in combination with trametinib); continue until disease progression or unacceptable toxicity.
  • Non-small cell lung cancer:
    Metastatic (with BRAF V600E mutation): 150 mg twice daily, approximately every 12 hours (in combination with trametinib); continue until disease progression or unacceptable toxicity.
  • Thyroid cancer, anaplastic, locally advanced or metastatic (with BRAF V600E mutation):
    150 mg twice daily, approximately every 12 hours (in combination with trametinib); continue until disease progression or unacceptable toxicity.

    Missed doses: A missed dose may be administered up to 6 hours prior to the next dose; do not administer if <6 hours until the next dose (do not make up the missed dose).
    • 小兒調整劑量
    腎功能調整劑量
    GFR >30 mL/minute/1.73 m2: No dosage adjustment necessary
    GFR <30 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling
    肝功能調整劑量
  • Mild impairment: (1) bilirubin ULN OR (2) bilirubin >1 to 1.5 times ULN and any AST
    No dosage adjustment necessary.
  • Moderate (bilirubin >1.5 to 3 times ULN and any AST) to severe (bilirubin >3 to 10 times ULN and any AST) impairment:
    There are no dosage adjustments provided in the manufacturer's labeling (an appropriate dose has not been established); however, hepatic metabolism and biliary excretion are the primary elimination routes for dabrafenib, and exposure may be increased in patients with moderate to severe impairment.
    • 安定性
    藥袋資訊
    臨床用途
    黑色素瘤、非小細胞肺癌
    主要副作用
    感染、嗜中性白血球減少、食慾降低、噁心、腹瀉、口腔炎、疲倦
    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
    因藥品低庫存，門診藥局不備庫 | 藥庫 口管G
    藥品外觀
    顏色
    19
    形狀
    剝痕
    N
    標記1
    GS LHF
    標記2
    75mg
    其他
    健保藥價
    636
    自費價
    845.88
    仿單
    資料庫
    健保給付規定