Anti-infective Agents : Antiretroviral Agents
OPREZ4 “Prezista FC tablet” 400 mg/tab
適應症：Prezista適用於與ritonavir (prezista/rtv)及其他抗反轉錄病毒藥物合併使用，以治療人類免疫缺乏病毒 (HIV-1)感染之成人患者。
Usual dose:
Adult: HIV infection
Treatment-naive, 800 mg PO qd concomitantly with ritonavir 100 mg PO qd, with food.
Treatment-experienced without darunavir resistance-associated substitutions, 800mg PO qd concomitantly with ritonavir 100 mg PO qd, with food.
Treatment-experienced and at least 1 darunavir resistance-associated substitution, 600 mg PO bid concomitantly with ritonavir 100 mg PO bid, with food; twice-daily dose recommended when genotypic testing is not feasible.
Pediatric:
General: do not use in p’t less than 3 years of age.
HIV infection:
(＜12 yrs): once-daily dosing not recommended
(≧3 yrs, ＞10 kg)
Treatment-naive or treatment-experienced without darunavir resistance-associated substitutions; qd with food.
＞10-11kg: 350 mg PO qd with ritonavir 64 mg PO qd
＞11-12kg: 385 mg PO qd with ritonavir 64 mg PO qd
＞12-13kg: 420 mg PO qd with ritonavir 80 mg PO qd
＞13-14kg: 455 mg PO qd with ritonavir 80 mg PO qd
＞14-15kg: 490 mg PO qd with ritonavir 96 mg PO qd
＞15-30kg: 600 mg PO qd with ritonavir 100 mg PO qd
＞30-40kg: 675 mg PO qd with ritonavir 100 mg PO qd
＞40kg: 800 mg PO qd with ritonavir 100 mg PO qd
Treatment-experienced with at least 1 darunavir resistance-associated substitution; bid with food.
＞10-11kg: 200 mg PO bid with ritonavir 32 mg PO bid
＞11-12kg: 220 mg PO bid with ritonavir 32 mg PO bid
＞12-13kg: 240 mg PO bid with ritonavir 40 mg PO bid
＞13-14kg: 260 mg PO bid with ritonavir 40 mg PO bid
＞14-15kg: 280 mg PO bid with ritonavir 48 mg PO bid
＞15-30kg: 375 mg PO bid with ritonavir 48 mg PO bid
＞30-40kg: 450 mg PO bid with ritonavir 60 mg PO bid
＞40kg: 600 mg PO bid with ritonavir 100 mg PO bid
Contraindication:
Concomitant use of agents highly-dependent on CYP3A for clearance and have a narrow therapeutic index (ie, alfuzosin, cisapride, dihydroergotamine, ergotamine, lovastatin, methylergonovine, oral midazolam, pimozide, rifampin, simvastatin, St. John’s wort, and triazolam); concomitant use of colchicine, dronedarone, or ranolazine; concomitant use of sildenafil for treatment of pulmonary arterial hypertension.
Adverse effect:
Common: rash, hypertriglyceridemia, serum cholesterol raised, abdominal pain, diarrhea, nausea, vomiting, headache.
Serious: acute generalized exanthematous pustulosis, skin reaction – finding, Stevens-Johnson syndrome, toxic epidermal necrolysis, diabetes mellitus, acute pancreatitis, hepatitis.
健保使用規範：給付規範須符合下列任一條件，並依行政衛生署疾病管制局「第二線抗人類免疫缺乏病毒藥品事前審查作業」辦理。
1.曾經接受過多種抗HIV藥物治療失敗，且根據HIV抗藥性報告，已無法選出足夠種類之第一線藥物有效控制病況，並應檢具HIV抗藥性報告。
2.根據HIV抗藥性報告，其他得選用之未具抗藥性第一線HIV治療藥物均產生嚴重副作用，其症狀符合「常見副作用(common toxicity criteria)」Grade 3以上者，並應檢具住院摘要或病歷紀錄。