| 简介：
近日，美国食品和药物管理局（FDA）批准Nocdurna（desmopressin acetate 醋酸去氨加压素）舌下含片，用于每晚至少醒来2次的成人患者治疗因夜间多尿引起的夜尿症。该药是获美国FDA批准治疗夜尿症的首个舌下片，这种舌下含片的剂型和性别特异性剂量被证明能够有效地减少18岁及以上成人夜尿次数。
批准日期：2018年06月22日 公司：辉凌制药
NOCDURNA（醋酸去氨加压素 desmopressin acetate）舌下含片
最初的美国批准：1978年
警告：HYPONATREMIA
查看完整的盒装警告的完整处方信息。
NOCDURNA可引起低钠血症，如果严重，可能会危及生命。
NOCDURNA禁用于严重低钠血症风险增加的患者，例如流体摄入过多的患者，可导致液体或电解质失调的疾病，以及使用袢利尿剂或全身性或吸入性糖皮质激素的患者。
在开始或停止NOCDURNA之前，确保血清钠浓度正常。在开始治疗后1周内和约1个月内测量血清钠，并在治疗期间进行周期性测量。更频繁地监测65岁及以上患者和患有低钠血症风险的患者的血清钠。
如果发生低钠血症，NOCDURNA可能需要暂时或永久停用。
作用机制
去氨加压素的抗利尿作用是通过刺激血管加压素2（V2）受体介导，从而增加肾脏中的水再吸收，并减少尿液产生。
适应症和用法
NOCDURNA是一种血管加压素类似物，适用于治疗夜间多尿症的夜间多尿，每晚至少醒过2次以避免麻醉。
剂量和给药
剂量信息：
女性：每天27.7微克，睡前一小时，腹部不用水
男性：每天55.3微克，睡前一小时，腹部不用水
剂量形式和强度
舌下片：27.7mcg醋酸去氨加压素（相当于25 mcg去氨加压素）和55.3 mcg醋酸去氨加压素（相当于50mcg去氨加压素）
禁忌症
低钠血症或低钠血症史。
烦渴。
同时使用袢利尿剂或全身或吸入糖皮质激素。
估计肾小球滤过率低于50 mL/min/1.73m2。
抗利尿激素分泌不当综合征（SIADH）
在可能导致液体或电解质不平衡的疾病期间。
心脏衰竭。
不受控制的高血压。
警告和注意事项
将液体摄入量限制在从给药前1小时到给药后8小时。不伴随液体摄入减少的治疗可导致液体潴留和低钠血症。
液体潴留：不建议有颅内压增高或尿潴留史的患者。
不良反应
常见的不良反应（> 2％发生率）包括口干，低钠血症或血钠减少和头晕。
要报告疑似不良反应，请致电1-888-337-7464或FDA 1-800-FDA-1088或www.fda.gov/medwatch联系Ferring。
药物相互作用
当NOCDURNA与可能增加低钠血症风险的药物同时使用时，更频繁地监测血清钠（例如，三环类抗抑郁药，选择性5-羟色胺再摄取抑制剂，氯丙嗪，阿片类镇痛药，噻嗪类利尿剂，NSAID，拉莫三嗪，氯磺丙脲和卡马西平）。
用于特定人群
怀孕：不建议使用NOCDURNA。
老年人使用：65岁或以上的低钠血症风险增加。更频繁地监测血清钠。
有关患者咨询信息和医疗指南，请参阅17
如何提供/存储和处理
NOCDURNA（醋酸去氨加压素）舌下片剂有：
27.7微克醋酸去氨加压素（相当于25微克去氨加压素）：白色圆形舌下片，一侧“25”。NDC 55566-5050-1 30个舌下含片的纸盒（3个泡罩包装，每个10片）
55.3 mcg醋酸去氨加压素（相当于50 mcg去氨加压素）：白色圆形舌下片，一面“50”。NDC 55566-5070-1 30个舌下含片的纸盒（3个泡罩包装，每个10片）
储存在20°至25°C（68°至77°F）; 允许的偏差在15°到30°C之间（59°和86°F）[参见USP受控室温]。 保持原包装，以防潮湿和光线。 打开个别药片水泡后立即使用。
NOCDURNA (desmopressin acetate) sublingual tablets
description
Drug Name: NOCDURNA
NDC: 55566-5050-0, 55566-5050-1, 55566-5070-0, 55566-5070-1
Active substance: DESMOPRESSIN ACETATE
Dosage: 27.7MCG; 53.3MCG
Dosage form: Sublingual Tablets
Market Status: Prescription
TE code: None
RLD: TBD; None
RS: No
Indications: Nocturia
Licensee: Ferring Pharmaceuticals, Inc.
Licensee Address: Parsippany, NJ 07054
Manufacturer: Ferring Pharmaceuticals Inc.
Manufacturer Address: Parsippany, NJ 07054, USA
Time to market: 06/21/2018
Sales time: 06/29/2018
Application No.: NDA022517
FDA Approves Nocdurna for Nocturia Due to Nocturnal Polyuria
The Food and Drug Administration (FDA) has approved Nocdurna (desmopressin acetate sublingual tablets; Ferring) for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void.
The approval was based on 3 double-blind, placebo-controlled trials and 1 open-label extension trial of up to 3 years in patients ≥18 years old. In clinical trials, nocturnal polyuria was defined as nighttime urine production exceeding one-third of the 24-hour urine production. The efficacy of Nocdurna was established in two 3-month trials; Study 1 enrolled only women while Study 2 enrolled only men.
In Study 1, women (N=237) were randomized to receive either sublingual Nocdurna 27.7mcg or placebo every night approximately 1 hour before bedtime; men (N=230) in Study 2 received either sublingual Nocdurna 55.3mcg or placebo. The co-primary endpoints in both trials were: 1) change in number of nocturia episodes/night from baseline during the 3-month period and; 2) 33% responder status during 3 months of treatment (a decrease of 33% in the mean number of nocturnal voids compared to baseline).
Results showed an average reduction of nocturnal voids from baseline of -1.5 (difference from placebo -0.3) for women and -1.3 for men (difference from placebo -0.4) with Nocdurna. In addition, 78% of women and 67% of men in the Nocdurna group achieved 33% responder status vs 62% and 50% for placebo, respectively.
Nocdurna carries a Boxed Warning for hyponatremia; the treatment is contraindicated in patients at increased risk of severe hyponatremia, such as those with excessive fluid intake, illnesses that cause fluid or electrolyte imbalances, and in patients using loop diuretics or systemic or inhaled glucocorticoids.
Nocdurna will be available in the second half of 2018 as a sublingual tablet in two dosage strengths: 27.7mcg (for women) and 55.3mcg (for men), both in 30-count cartons. The recommended dose for women is lower as women were more sensitive to the effects of Nocdurna and had a higher risk of hyponatremia with the higher dose in clinical trials.
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