美時：學名藥Paricalcitol Capsule已獲美FDA之正式核可並取得藥證 2016/02/26 07:02 證交所重大訊息公告 (1795)美時公告本公司學名藥 Paricalcitol Capsules 已獲得美國FDA 之正式核可並取得藥證 1.事實發生日:105/02/25 2.公司名稱:美時化學製藥股份有限公司 3.與公司關係[請輸入本公司或子公司]:本公司 4.相互持股比例:不適用 5.傳播媒體名稱:不適用 6.報導內容:不適用 7.發生緣由: 公告本公司學名藥Paricalcitol Capsules 1 mcg、2 mcg及4 mcg已獲得美國FDA之正式核可(final approval)通知 ，將旋即進行該學名藥之上市準備工作。 8.因應措施:無 9.其他應敘明事項:無。
Paricalcitol (chemically it is 19-nor-1,25-(OH)2-vitamin D2. Marketed by Abbott Laboratories under the trade name Zemplar) is a drug used for the prevention and treatment of secondary hyperparathyroidism (excessive secretion of parathyroid hormone) associated with chronic renal failure. It is an analog of 1,25-dihydroxyergocalciferol, the active form of vitamin D2 (ergocalciferol). Its primary use in medicine is in the treatment of secondary hyperparathyroidism associated with chronic kidney disease. In three placebo-controlled studies, chronic renal failure patients treated with paricalcitol achieved a mean parathyroid hormone (PTH) reduction of 30% in six weeks. Additionally there was no difference in incidence of hypercalcemia or hyperphosphatemia when compared to placebo. A double-blind randomised study with 263 dialysis patients showed a significant advantage over calcitriol (also known as activated vitamin D3; a similar molecule to 1,25-dihydroxyergocalciferol, adding a methyl group on C24 and lacking a double-bond in the C22 position). After 18 weeks, all patients in the paricalcitol group had reached the target parathormone level of 100 to 300 pg/ml, versus none in the calcitriol group. Combination therapy with paricalcitol and trandolapril has been found to reduce fibrosis in obstructive uropathy. Forty-eight week therapy with paricalcitol did not alter left ventricular mass index or improve certain measures of diastolic dysfunction in 227 patients with chronic kidney disease.
Paricalcitol（Zemplar 亞培腎骨樂）內容轉載自：行政院退除役官兵輔導委員會台北榮民總醫院藥劑部團隊撰稿 慢性腎衰竭之病患由於腎臟功能逐漸惡化，易導致體內血鈣濃度降低、血磷升高以及活性維生素D缺乏，引起副甲狀腺素製造、分泌增加，造成次發性副甲狀腺機能亢進，繼而影響骨骼、心血管等正常功能而使健康受到危害。臨床上控制此疾病自然惡化的治療藥物除了口服磷結合劑（如鈣鋁製劑、碳酸鑭及sevelamer等）外，亦可藉由補充維生素D以降低副甲狀腺素的濃度。Paricalcitol為新的維生素D衍生物，可透過和維生素D接受體結合，選擇性地活化維生素D相關生物途徑進而抑制副甲狀腺素的合成，臨床應用於治療次發性副甲狀腺機能亢進。目前巿售之paricalcitol包含兩種劑型：口服膠囊與注射劑型。口服膠囊適用於慢性腎臟疾病第三、四期透析之病患，使用較注射劑方便；注射劑型則因吸收完全，可達較高血中濃度，適用於治療慢性腎臟疾病第五期引發副甲狀腺機能亢進之透析病患。Paricalcitol起始使用劑量依血中副甲狀腺素濃度及鈣、磷值而定，若未達滿意療效，可每2-4週調增劑量。Paricalcitol主要經由肝臟和非肝臟途徑代謝，故與肝臟代謝酵素CYP3A4的抑制藥物如clarithromycin（抗細菌）、ketoconazole（抗黴菌）、itraconazole（抗黴菌）、voriconazole（抗黴菌）等併用時，可能會增加paricalcitol血中濃度；與digoxin（心血管藥物）併用可能因血鈣升高而使digoxin之毒性增加，故應嚴密監控digoxin之血中濃度。對肝功能不全病患，使用paricalcitol時不需特別調整劑量，血液透析亦不會影響paricalcitol排除。由於動物試驗顯示具胎兒毒性，懷孕用藥分級屬於C級，故懷孕婦女應避免使用，對於授乳婦女亦不建議使用。Paricalcitol的不良反應以噁心 (13%)、嘔吐(8%)、水腫 (7%)及紅疹最為常見，雖然paricalcitol僅選擇性地活化維生素D之相關生物活性，但是仍有少數高血鈣不良反應之案例報告，故一旦發生高血鈣需立即降低劑量或中斷治療；當劑量調整完成後，血清鈣磷值之監測可降為每月一次，副甲狀腺素檢測則每3個月一次。Paricalcitol為新一代具選擇性的維生素D活化物，與calcitriol相較可增加透析病患存活率且減少高血鈣及其他副作用的發生，能有效控制次發性副甲狀腺機能亢進。此新一代的藥品可以提供洗腎病患另一個治療的新選擇，但是目前健保尚未給付，患者需自費使用。
最後補充一些劑量的部份：Adult Dosing, Dosage forms: 1,2,4 mcg; IV , hyperparathyroidism, secondary , [PO route, iPTH <500] Dose: 1 mcg PO qd; Alt: 2 mcg PO 3x/wk; Info: adjust dose based on iPTH levels, [PO route, iPTH >500] Dose: 2 mcg PO qd; Alt: 4 mcg PO 3x/wk; Info: adjust dose based on iPTH levels, [IV route]Dose: 0.04-0.1 mcg/kg IV 3/wk, incr. dose 2-4 mcg/dose q2-4wk based on iPTH levels; Max: 0.24 mcg/kg; Info: give during dialysis, Peds Dosing Dosage forms: IV , hyperparathyroidism, secondary [>5 yo] Dose: 0.04-0.1 mcg/kg IV 3/wk, incr. dose 2-4 mcg/dose q2-4wk based on iPTH levels; Max: 0.24 mcg/kg; Info: given during dialysis. Source: http://mulicia.pixnet.net/blog
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