藥碼
ODE01
藥名
Tenofovir/FTC/Rilpivirine 複方錠劑
英文商品名
Odefsey 複方 錠劑
中文商品名
安以斯膜衣錠
螢幕名
Odefsey 複方 錠劑
劑型
Tab
規格
Emtricitabine 200 mg/ Rilpivirine 25 mg/ Tenofovir alafenamide 25 mg
成分
藥理分類
Antiretrovials Antivirals
健保碼
BC27505100
ATC碼
藥品圖片
外觀圖片
適應症
#最小單位貼紙

抗病毒藥品
1. Treatment of HIV-1 infection in patients ≥12 y/o as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA ≤100,000 copies/mL
2. To replace a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) for ≥6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components

#仿單變更2022
藥理
Rilpivirine: Non-nucleoside Reverse Transcriptase Inhibitor
Binds to reverse transcriptase and does not require intracellular phosphorylation for antiviral activity
Emtricitabine: Nucleoside Reverse Transcriptase Inhibitor
Cytidine analogue
Tenofovir alafenamide fumarate: Non-nucleotide Reverse Transcriptase Inhibito
analog of adenosine 5'-monophosphate
藥動學
禁忌症
Concurrent use of carbamazepine, systemic dexamethasone (>1 dose), oxcarbazepine, phenobarbital, phenytoin, proton pump inhibitors (PPIs) (eg, dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole), rifampin, rifapentine, and/or St John's wort.
懷孕分類
Females who become pregnant while taking this combination may continue if viral suppression is effective and the regimen is well tolerated; however, more frequent monitoring is recommended.
Contraceptive measures should be taken while using the drug.<20221220>
哺乳分類
Emtricitabine is present in breast milk; it is not known if rilpivirine or tenofovir alafenamide are present in breast milk.
To prevent HIV transmission to infants,women with HIV should not breastfeed their babies. . <20240223>
副作用
Headache, sleep disorder, abnormal dreams, diarrhea, nausea, flatulence, decreased bone mineral density, drowsy/fatigue (影響駕駛、操作機械能力)<20220429>
劑量和給藥方法
One tablet once daily, take with a meal
(Do not use in patients with HIV RNA ≥100,000 copies/mL and/or CD4 count ≤200 cells/mm3)
小兒調整劑量
1. Ages <12 years or weight <35 kg: Not recommended
2. Children >12 years and Adolescents weighing >35 kg: One tablet once daily
腎功能調整劑量
1. CrCl ≥30 mL/min: No dosage adjustment necessary
2. CrCl <30 mL/min: Use is not recommended
3. ESRD on hemodialysis: One tablet once daily; administer after hemodialysis on dialysis days.
4. Discontinuation should be considered in patients with clinically significant decreased renal function or evidence of proximal tubular disease.<20221220>
肝功能調整劑量
1. Mild to moderate impairment (Child-Pugh class A or B): No dosage adjustments necessary
2. Severe impairment (Child-Pugh class C): No dosage adjustments provided in the manufacturer's labeling (has not been studied)
安定性
藥袋資訊
臨床用途
抗病毒藥物
主要副作用
腹瀉、嘔吐、昏睡、失眠、發燒厭食、高三酸甘油脂血症、關節痛
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 V4 | 藥庫 口F12
藥品外觀
顏色
14
形狀
03
剝痕
標記1
GSI, 255
標記2
其他
健保藥價
440
自費價
585.2
仿單
資料庫
健保給付規定