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芬太尼口腔粘膜贴片(fentanyl，Abstral)

2011-03-07 21:49:33 作者：新特药房来源：中国亲新特药网天津分站浏览次数：433 文字大小：【大】【中】【小】

简介： 美国食品药品监督管理局(FDA)宣布批准芬太尼片剂((fentanyl，Abstral)口腔粘膜贴片用于缓解对阿片类镇痛药物耐受的癌症患者的“阵痛”。FDA指出，只有有相关资质的医生才能具有此药物的处方权，任何参与 ...

美国食品药品监督管理局(FDA)宣布批准芬太尼片剂((fentanyl，Abstral)口腔粘膜贴片用于缓解对阿片类镇痛药物耐受的癌症患者的“阵痛”。
FDA指出，只有有相关资质的医生才能具有此药物的处方权，任何参与Abstral销售或使用的药店，经销商或医疗专业人士必须接受风险评估与降低计划（the Risk Evaluation and Mitigation Strategy，REMS）课程，以将误用、滥用的危害降到最低。

一项涉及311名有“阵痛”症状但对阿片类药物耐受的癌症患者的临床试验对Abstral的安全性进行了评估，其中最主要的副作用包括恶心、便秘、嗜睡和头痛。

FDA同时也警告说已经有类似的芬太尼速释制剂致患者死亡的报道，其死亡的主要原因为药物选择不当和/或剂量不当。

Abstral由位于新泽西州Bedminister的ProStraken公司生产。

制造商：
ProStrakan公司

药理分类：
阿片类药物。

活性成分（补）：
芬太尼100mcg，200mcg，400mcg，600mcg，800mcg;舌下片
指示（补）：
突破疼痛，阿片类药物耐受已经接受患者和谁是潜在的持久性癌性疼痛治疗阿片类药物耐受持续。阿片类药物耐受的病人服用：≥60mg/day口服吗啡，羟考酮≥30mg/day，酮≥8mg/day，羟≥25mg/day，或另一种≥1周阿片相等剂量;或芬太尼透皮≥25mcg /人力资源。

药理作用：
像其他纯阿片受体激动剂，对μ-受体在中枢神经系统产生镇痛芬太尼行为和中枢神经系统抑郁症。

临床试验：
双盲，安慰剂对照，进行交叉研究，以评估癌症患者在治疗癌症疼痛的突破Abstral疗效。开放标签滴定确定了Abstral剂量与一名病人取得足够的镇痛耐受的副作用在100 - 800mcg范围。谁发现了成功的患者的剂量，随机序列的10个处理;与安慰剂7 Abstral和3。

谁的131名患者进入研究滴定阶段，60％实现了成功的阶段，在滴定剂量。主要结果测量，疼痛强度差在30 Abstral处理发作分钟平均金额有统计学显着高于安慰剂治疗发作更高。以平均疼痛强度差异显着性差异，看到在10分钟。

法律分类：
印度工业联合会

成人：
≥18岁：不要咀嚼，吸吮，吞咽药片。允许药片溶解在舌下腔。不要吃或喝，直到药片完全溶解。个别化。最初一100mcg剂量;如果有足够的镇痛在30分钟内得到继续治疗这个剂量后发作。如果不足，给予第二剂量（后30分钟）。对于未来的事件，如果不与100mcg镇痛剂量滴定的100mcg增量高达400mcg需要取得的;如果400mcg剂量不足，滴定至600mcg剂量，然后如果需要800mcg剂量。可使用100mcg或200mcg片剂任何单一剂量;在同一时间最多4粒。最多2剂/集，最多4次/日。治疗前等待另一个事件至少2个小时。维护：只用一个适当的强度片剂。不要从其他芬太尼产品转换的基础上每微克芬太尼产品或与其他交换微克。急救药物可以使用。

儿童：
<18年：不推荐。

禁忌（补）：
不适用于阿片类药物的非耐受的病人。急性或后运疼痛（包括头痛/偏头痛，牙痛，或ER）。

警告/注意事项：
呼吸系统疾病或抑郁症。头部受伤。颅内压增高。缓慢性心律失常。受损的肺，心，肾或肝功能。老人。虚弱。妊娠（Cat.C）。劳动和分娩，哺乳期妇女：不推荐。

互动（补）：
不推荐单胺氧化抑制剂后14天。 Potentiates中枢神经系统抑郁症，酒精，其他中枢神经系统抑制剂（如噻嗪，骨骼肌肉松弛剂，抗组织胺药，安眠药）。由CYP3A4抑制剂Potentiated（如大环内酯类，唑类抗真菌剂，阿瑞，蛋白酶抑制剂，奈法唑酮，维拉帕米，地尔硫卓）。 CYP3A4的诱导剂的拮抗（如巴比妥酸盐，依非韦伦，莫达非尼，奈韦拉平，抗惊厥药，吡格列酮，曲格列酮，利福布丁，利福平，圣约翰草）。

不良反应（补）：
恶心，嗜睡，头痛，便秘，呼吸/循环抑制。

注释：
可通过限制分配方案。请拨打（888）227-8725报名。妥善处理和处置;可能是致命的儿童。

如何提供：
舌下标签- 32

Abstral transmucosal tablets approved for breakthrough cancer pain

Abstral (fentanyl transmucosal immediate-release tablets, from ProStrakan) has been approved by the FDA for the management of breakthrough pain in adult patients with cancer, ≥18 years old, who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medicine. Fentanyl immediate-release transmucosal medications are administered on the soft surfaces of the mouth where they dissolve and are absorbed. This approval was based on data from a study conducted in 311 opioid-tolerant cancer patients with breakthrough pain.

Abstral will be available only through a Risk Evaluation and Mitigation Strategy (REMS) program, which is intended to minimize the risk of misuse, abuse, addiction and overdose. Under this program, pharmacies, distributors, and health care professionals who prescribe to outpatients are required to enroll in the program to prescribe, dispense and distribute this product.

Abstral is expected to be available early in the first quarter of 2011 in 100mcg, 200mcg, 300mcg, 400mcg, 600mcg, and 800mcg dosage strengths.

ABSTRAL

Manufacturer:

ProStrakan Inc.

Pharmacological Class:

Opioid.

Active Ingredient(s):

Fentanyl 100mcg, 200mcg, 400mcg, 600mcg, 800mcg; sublingual tablets.

Indication(s):

Breakthrough pain, in opioid-tolerant patients already receiving and who are tolerant to continuous opioid therapy for underlying persistent cancer pain. Opioid-tolerant patients are those taking: Oral morphine ≥60mg/day, oxycodone ≥30mg/day, hydromorphone ≥8mg/day, oxymorphone ≥25mg/day, or equianalgesic dose of another opioid for ≥1 week; or transdermal fentanyl ≥25mcg/hr.

Pharmacology:

Like other pure opioid agonists, fentanyl acts on the mu-receptors in the CNS to produce analgesia and CNS depression.

Clinical Trials:

A double-blind, placebo-controlled, crossover study was performed in cancer patients to evaluate the efficacy of Abstral in treating breakthrough cancer pain. Open-label titration identified a dose of Abstral in which a patient obtained adequate analgesia with tolerable side effects, within the range of 100–800mcg. Patients who identified a successful dose were randomized to a sequence of 10 treatments; 7 with Abstral and 3 with placebo.

Of the 131 patients who entered the titration phase of the study, 60% achieved a successful dose during the titration phase. The primary outcome measure, the mean sum of pain intensity difference at 30 minutes for Abstral-treated episodes was statistically significantly higher than for placebo-treated episodes. A significant difference in mean pain intensity difference was seen at 10 minutes.

Legal Classification:

CII

Adults:

≥18 years: Do not chew, suck, swallow tablets. Allow tablets to dissolve in sublingual cavity. Do not eat or drink until tablet completely dissolves. Individualize. Initially one 100mcg dose; if adequate analgesia is obtained within 30 minutes, continue to treat subsequent episodes with this dose. If inadequate, give 2^nd dose (after 30 minutes). For future episodes, if analgesia is not obtained with 100mcg dose, titrate in increments of 100mcg up to 400mcg as needed; if 400mcg dose is inadequate, titrate to 600mcg dose, then 800mcg dose if needed. May use 100mcg or 200mcg tablets for any single dose; maximum 4 tablets at one time. Max 2 doses/episode, up to 4 episodes/day. Wait at least 2 hours before treating another episode. Maintenance: use only one tablet of appropriate strength. Do not convert from other fentanyl products on a mcg per mcg basis or interchange with other fentanyl products. Rescue medication may be used.

Children:

<18 years: not recommended.

Contraindication(s):

Not for opioid non-tolerant patients. Acute or post-op pain (including headache/migraine, dental pain, or ER).

Warnings/Precautions:

Respiratory disorders or depression. Head injury. Increased intracranial pressure. Bradyarrhythmias. Impaired pulmonary, cardio, renal, or hepatic function. Elderly. Debilitated. Pregnancy (Cat.C). Labor & delivery, nursing mothers: not recommended.

Interaction(s):

Not recommended within 14 days of MAOIs. Potentiates CNS depression with alcohol, other CNS depressants (eg, phenothiazines, skeletal muscle relaxants, antihistamines, hypnotics). Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, aprepitant, protease inhibitors, nefazodone, verapamil, diltiazem). Antagonized by CYP3A4 inducers (eg, barbiturates, efavirenz, modafinil, nevirapine, anticonvulsants, pioglitazone, troglitazone, rifabutin, rifampin, St John’s wort).