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Symproic(Naldemedine Tablets)

2017-05-03 01:16:04 作者：新特药房来源：互联网浏览次数：0 文字大小：【大】【中】【小】

简介： FDA批准Symproic(Naldemedine)用于非癌症患者阿片类药物引起的便秘近日，美国FDA已批准Symproic(Naldemedine)0.2mg片剂称CII作为一天一次的外周作用-阿片受体拮抗剂用于慢性非癌性疼痛成人患者中阿片类药 ...

关键字：naldemedine商品名symproic 阿片诱导便秘

FDA批准Symproic(Naldemedine)用于非癌症患者阿片类药物引起的便秘
近日，美国FDA已批准Symproic(Naldemedine)0.2mg片剂称CII作为一天一次的外周作用-阿片受体拮抗剂用于慢性非癌性疼痛成人患者中阿片类药物引起的便秘的治疗。
批准日期：2017年3月23日；公司：Shionogi Inc
SYMPROIC(naldemedine)片，为口服使用，C-II
美国初次批准：2017
作用机制
Naldemedine是一种阿片拮抗剂对µ[mu]-，δ[delta]-，和κ[kappa\-阿片受体的结合亲和力。Naldemedine功能如同一个在组织中外周-作用µ-阿片受体拮抗剂例如胃肠道，因此减低阿片的便秘效应。
Naldemedine是纳曲酮[naltrexone]的衍生物对它已被加上侧链，它增加分子量和极性表面积，因此减低它跨越血脑屏障(BBB)的能力。Naldemedine也是P-糖蛋白(P-gp)流出转运蛋白的底物。根据这些性质，naldemedine的中枢神经系统CNS穿透预计在推荐剂量水平是可忽略不计，限制与对中枢介导阿片镇痛干扰。
适应证和用途
SYMPROIC是一种阿片拮抗剂适用为阿片诱导便秘(OIC)在有慢性非-癌痛成年患者的治疗
剂量和给药方法
给药：
●SYMPROIC开始前不需要另外镇痛给药方案的改变。
●患者接受阿片类共少于4周可能对SYMPROIC较低反应。
● 终止SYMPROIC如治疗用阿片疼痛药物剂量也被终止。
● 在成年找，推荐剂量为0.2 mg每天1次有或无食物
剂型和规格
片：0.2mg naldemedine
禁忌证
●患者有已知怀疑胃肠道阻塞或处于复发阻塞风险增加。
●患者有对naldemedine超敏性反应的病史
警告和注意事项
● 胃肠道穿孔：在有已知或怀疑GI道病变患者考虑总体风险获益。对严重，持续，或恶化的腹痛监视：如症状发展终止
● 阿片类戒断综合征：在有对血脑屏障障碍患者考虑总体风险获益。监视阿片类戒断综合征的症状。
不良反应
最常见不良反应(≥2%)为：腹痛，腹泻，和恶心。
药物相互作用
● 强CYP3A诱导剂(如，利福平[rifampin])：减低naldemedine浓度：避免同时使用(7)
● 其他阿片拮抗剂：对增加相加作用和阿片类戒断综合征风险潜能：避免同时使用(7)
● 中度(如，氟康唑)和强(如，伊曲康唑[itraconazole]) CYP3A4抑制剂：增加naldemedine浓度：监视对不良反应。
● P-gp抑制剂(如，环孢霉素[cyclosporine])：监视对不良反应。
在特殊人群中使用
●妊娠：可能促进在胎儿中阿片类戒断综合征。
●哺乳：终止药物或哺乳喂养考虑药物对母亲的重要性。
●肝受损：在严重损伤中避免。
供应/贮存和处置
SYMPROIC是以0.2 mg naldemedine片供应在90片瓶中 - NDC 59011-523-90。
贮存SYMPROIC在抗光容器在20至25°C(68至 77°F)：外出允许至15至30°C(59至86°F)[见USP控制室温]。
FDA Approves Symproic® (naldemedine) Once-Daily Tablets C-II for the Treatment of Opioid-Induced Constipation in Adults with Chronic Non-Cancer Pain
U.S. Food and Drug Administration (FDA) approved Symproic® (naldemedine) 0.2 mg tablets C-II as a once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.
Symproic is currently a Schedule II controlled substance because it is structurally related to naltrexone. Shionogi Inc. submitted a petition for the descheduling of Symproic, or removal of the controlled substance classification, to the U.S. Drug Enforcement Administration (DEA), which is currently under evaluation. Symproic will be jointly launched and commercialized in the U.S. with Purdue Pharma and is expected to be commercially available mid-summer.
“The FDA approval of Symproic provides a safe and effective therapy for adult patients suffering from chronic non-cancer pain and struggling with opioid-induced constipation,” said John Keller, President and Chief Executive Officer, Shionogi Inc. “We believe Symproic will offer a new therapeutic option to help reduce the needless suffering for those who experience OIC. The launch of Symproic with Purdue Pharma this summer will mark yet another milestone in our commitment to protect the health and well-being of patients we serve.”
The FDA approval of Symproic was based on data from the COMPOSE program, a global comprehensive development program comprised of clinical studies conducted in adult patients with OIC and chronic non-cancer pain. It was comprised of three studies: COMPOSE I, COMPOSE II and COMPOSE III. COMPOSE I and II were 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies, while COMPOSE III was a 52-week, randomized, double-blind, placebo-controlled, long-term safety study.
“By entering this exciting new therapeutic area with Shionogi Inc., we have the opportunity to further help patients with chronic non-cancer pain by offering more comprehensive care to both patients and doctors,” said Mark Timney, President and Chief Executive Officer, Purdue Pharma L.P. “The approval of Symproic marks a significant advancement in our partnership with Shionogi as well as the diversification of our product portfolio.”
Please see Important Safety Information, including Warnings & Precautions and Adverse Reactions below.
About Opioid-Induced Constipation
Constipation is one of the most commonly reported side effects associated with opioid treatment, including among patients with chronic non-cancer pain.When opioids bind to specific proteins called mu-opioid receptors in the gastrointestinal (GI) tract, constipation may occur. Opioid-induced constipation (OIC) is a result of increased fluid absorption and reduced GI motility due to opioid receptor binding in the GI tract. OIC is defined as a change in bowel habits that is characterized by any of the following after initiating opioid therapy: reduced bowel movement frequency, development or worsening of straining to pass bowel movements, a sense of incomplete rectal evacuation, or harder stool consistency.In patients with chronic non-cancer pain, the prevalence of OIC ranges from approximately 40-50 percent.3,4,5,6 In a survey of 322 patients taking daily opioids for chronic pain, 33 percent of patients missed, decreased or stopped opioid use to ease bowel movements.
Indication
Symproic® (naldemedine) CII is an opioid antagonist indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.
Important Safety Information about Symproic
Symproic is contraindicated in:
•Patients with known or suspected gastrointestinal (GI) obstruction and patients at increased risk of recurrent obstruction, due to the potential for GI perforation.
•Patients with a history of a hypersensitivity reaction to Symproic. Reactions have included bronchospasm and rash.
Warnings and Precautions
Cases of GI perforation have been reported with use of another peripherally acting opioid antagonist in patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract. Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue if this symptom develops.
Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, increased lacrimation, hot flush/flushing, pyrexia, sneezing, feeling cold, abdominal pain, diarrhea, nausea, and vomiting have occurred in patients treated with Symproic.
Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. Take into account the overall risk-benefit profile when using Symproic in such patients. Monitor for symptoms of opioid withdrawal in such patients.
Drug Interactions
Avoid use with strong CYP3A inducers (e.g. rifampin, carbamazepine, phenytoin, St. John’s Wort) because it may reduce the efficacy of Symproic.
Avoid use of Symproic with another opioid antagonist due to potential for additive effect and increased risk of opioid withdrawal.
Use in Specific Populations
Symproic crosses the placenta and may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier. Symproic should be used during pregnancy only if the potential benefit justifies the potential risk. Because of the potential for serious adverse reactions, including opioid withdrawal, in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Controlled Substance
Symproic contains naldemedine, a Schedule II controlled substance.
Adverse Reactions
The most common adverse reactions with Symproic as compared to placebo in clinical trials were: abdominal pain (8% vs 2%), diarrhea (7% vs 2%), nausea (4% vs 2%), and gastroenteritis (2% vs 1%).