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Spravato Nasal Spray Kit 56mg(esketamine 艾氯胺酮鼻腔喷雾剂)
药店国别  
产地国家 美国 
处 方 药: 是 
所属类别 56毫克/剂量 2个X28毫克 
包装规格 56毫克/剂量 2个X28毫克 
计价单位: 套件 
生产厂家中文参考译名:
Janssen Pharmaceuticals Inc.
生产厂家英文名:
Janssen Pharmaceuticals Inc.
该药品相关信息网址1:
https://www.drugs.com/nda/esketamine_180904.htm
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
Spravato Nasal Spray Kit 56mg/Dose 2X28mg
原产地英文药品名:
esketamine
中文参考商品译名:
Spravato鼻腔喷雾剂/套件 56毫克/剂量 2个X28毫克
中文参考药品译名:
艾氯胺酮
曾用名:
简介:

 

 近日,美国食品和药物管理局(FDA)批准SPRAVATO(esketamine)CIII鼻喷雾剂与口服抗抑郁药一起使用成人具有治疗抵抗性抑郁症(TRD).目前正在患有严重抑郁症(MDD)的人如果对目前抑郁发作中至少两种剂量和持续时间足够的抗抑郁药没有充分应答,则被认为患有TRD。
据估计,约有三分之一的美国MDD患者患有TRD。SPRAVATO™带有关于风险评估和缓解策略(REMS)的盒装警告以及儿科患者和年轻成人的自杀念头和行为风险.
该药物与口服抗抑郁药一起用作鼻腔喷雾剂,适用于对其他治疗无效的患者。Spravato是美国食品和药物管理局批准的第一个新的抑郁症治疗方法。
批准日期:2019年3月5日 公司:Janssen Pharmaceuticals, Inc.
SPRAVATO™(艾氯胺酮[esketamine])鼻喷雾剂,CIII
美国最初批准:1970年
警告:
SEDATION;解离;滥用和误用;和自杀的想法和行为查看完整的盒装警告的完整处方信息。
●给药后镇静和解离的风险。监测患者在给药后至少两小时。
●滥用和滥用的可能性。考虑在使用较高风险的患者之前使用SPRAVATO的风险和益处。监测患者是否有滥用和滥用的迹象和症状。
●SPRAVATO仅通过名为theSPRAVATO REMS的受限程序提供。
●服用抗抑郁药的儿童和青少年成年患者的自杀念头和行为风险增加。密切监测白藜芦醇治疗患者的临床恶化和自杀念头和行为的出现。SPRAVATO未被批准用于儿科患者。
作用机制
Esketamine,外消旋氯胺酮的S-对映体,是N-甲基-D-天冬氨酸(NMDA)受体(离子型谷氨酸受体)的非选择性非竞争性拮抗剂。 依他胺发挥其抗抑郁作用的机制尚不清楚。 艾氯胺酮(noresketamine)的主要循环代谢物在相同受体下表现出较低亲和力的活性。
适应症和用法
SPRAVATO™是一种非竞争性N-甲基D-天冬氨酸(NMDA)受体拮抗剂,与口服抗抑郁药一起用于治疗成人的治疗抵抗性抑郁症(TRD)。
使用限制:SPRAVATO未被批准作为麻醉剂。 SPRAVATO作为麻醉剂的安全性和有效性尚未确定。
剂量和给药
•在医疗保健提供者的监督下鼻内管理SPRAVATO。
•在给药前后评估血压。
•应在诱导阶段结束时评估治疗效益的证据,以确定是否需要继续治疗。
•有关推荐和维护阶段的建议剂量,请参阅完整的处方信息。
有关重要的管理说明,请参阅完整的处方信息。
剂量形式和强度
鼻腔喷雾:每个装置含28毫克的艾氯胺酮。每个鼻喷雾装置提供两次喷雾,其含有总共28mg的艾氯胺酮。
禁忌症
•动脉瘤性血管疾病(包括胸主动脉和腹主动脉,颅内和外周动脉血管)或动静脉畸形。
•脑出血。
•对依他胺,氯胺酮或任何赋形剂过敏。
警告和注意事项
•血压升高:患有心血管和脑血管疾病的患者和风险因素可能会增加相关不良反应的风险。
•认知障碍:SPRAVATO可能会损害注意力,判断力,思维,反应速度和运动技能。
•驱动和操作机器的能力受损:在安静睡眠后的第二天,不要驾驶或操作机器。
•胚胎 - 胎儿毒性:可能导致胎儿伤害。考虑有生育潜力的女性的妊娠计划和预防。
不良反应
最常见的不良反应(发生率≥5%,至少两次安慰剂加口服抗抑郁药)是解离,头晕,恶心,镇静,眩晕,感觉减退,焦虑,嗜睡,血压升高,呕吐和醉酒。
要报告疑似不良反应,请致电1-800-JANSSEN(1-800-526-7736)或FDA 1-800--FDA-1088或www.fda.gov/medwatch联系JanssenPharmaceuticals,Inc ..
用于特定人群
•哺乳期:不推荐母乳喂养。
包装提供/存储和处理
SPRAVATO鼻喷雾剂可作为艾氯胺酮在鼻喷雾装置内的玻璃瓶中的水溶液。每个鼻喷雾装置递送两种喷雾剂,其含有总共28mg的艾氯胺酮(以32.3mg盐酸艾氯胺酮的形式提供)。
SPRAVATO可在以下演示文稿中找到:
•56mg剂量试剂盒:单位剂量纸盒,含有2个28mg鼻喷雾装置(总剂量56mg)(NDC 50458-028-02)。
•84mg剂量试剂盒:单位剂量纸盒,含有3个28mg鼻腔喷雾装置(总剂量为84mg)(NDC 50458-028-03)。
在每个试剂盒中,每个28mg装置单独包装在密封的泡罩(NDC 50458-028-00)中。
存储
储存在20°至25°C(68°至77°F);允许偏差在15°至30°C(59°至86°F)之间[参见USP Controlled Room Temperature]。
处置
必须按照适用于附表III药品的设施程序,以及适用的联邦,州和地方法规,对SPRAVATO鼻喷雾装置进行处理,并给予足够的安全性,问责性和适当的处置。
完整说明书附件:
http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SPRAVATO-pi.pdf
spravato(esketamin)
Indication
SPRAVATO(esketamine) CIII Nasal Spray is indicated, in conjunction with an oral antidepressant (AD), for the treatment of treatment-resistant depression (TRD) in adults.
SPRAVATO™ is not approved as an anesthetic agent. The safety and effectiveness of SPRAVATO™ as an anesthetic agent have not been established.
Important Safety Information
WARNING: SEDATION, DISSOCIATION; ABUSE AND MISUSE; and SUICIDAL THOUGHTS AND BEHAVIORS
See full prescribing information for complete boxed warning
Risk for sedation and dissociation after administration. Monitor patients for at least two hours after administration (5.1, 5.2).
Potential for abuse and misuse. Consider the risks and benefits of using SPRAVATO™ prior to use in patients at higher risk of abuse. Monitor for signs and symptoms of abuse and misuse (5.3).
SPRAVATO™ is only available through a restricted program called the SPRAVATO™ REMS.
Increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. SPRAVATO™ is not approved for use in pediatric patients.
CONTRAINDICATIONS
SPRAVATO™ is contraindicated in patients with:
Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation
History of intracerebral hemorrhage
Hypersensitivity to esketamine, ketamine, or any of the excipients
WARNINGS AND PRECAUTIONS
Sedation: In clinical trials, 49% to 61% of SPRAVATO™-treated patients developed sedation and 0.3% of SPRAVATO™-treated patients experienced loss of consciousness.
Because of the possibility of delayed or prolonged sedation, patients must be monitored by a healthcare provider for at least 2 hours at each treatment session, followed by an assessment to determine when the patient is considered clinically stable and ready to leave the healthcare setting.
Closely monitor for sedation with concomitant use of SPRAVATO™ with CNS depressants [see Drug Interaction].
SPRAVATO™ is available only through a restricted program under a REMS.
Dissociation: The most common psychological effects of SPRAVATO™ were dissociative or perceptual changes (including distortion of time, space and illusions), derealization and depersonalization (61% to 75% of SPRAVATO™-treated patients developed dissociative or perceptual changes). Given its potential to induce dissociative effects, carefully assess patients with psychosis before administering SPRAVATO™; treatment should be initiated only if the benefit outweighs the risk.
Because of the risks of dissociation, patients must be monitored by a healthcare provider for at least 2 hours at each treatment session, followed by an assessment to determine when the patient is considered clinically stable and ready to leave the healthcare setting.
SPRAVATO™ is available only through a restricted program under a REMS.
Abuse and Misuse: SPRAVATO™ contains esketamine, a Schedule III controlled substance (CIII), and may be subject to abuse and diversion. Assess each patient’s risk for abuse or misuse prior to prescribing and monitor all patients for the development of these behaviors or conditions, including drug-seeking behavior, while on therapy. Individuals with a history of drug abuse or dependence are at greater risk; therefore, use careful consideration prior to treatment of individuals with a history of substance use disorder and monitor for signs of abuse or dependence.
SPRAVATO™ is available only through a restricted program under a REMS.
SPRAVATO™ Risk eva luation and Mitigation Strategy (REMS): SPRAVATO™ is available only through a restricted program called the SPRAVATO™ REMS because of the risks of serious adverse outcomes from sedation, dissociation, and abuse and misuse.
Important requirements of the SPRAVATO™ REMS include the following:
Healthcare settings must be certified in the program and ensure that SPRAVATO™ is:
Only dispensed in healthcare settings and administered to patients who are enrolled in the program.
Administered by patients under the direct observation of a healthcare provider and that patients are monitored by a healthcare provider for at least 2 hours after administration of SPRAVATO™.
Pharmacies must be certified in the REMS and must only dispense SPRAVATO™ to healthcare settings that are certified in the program.
Further information, including a list of certified pharmacies, is available at www.SPRAVATOrems.com or 1-855-382-6022.
Suicidal Thoughts and Behaviors in Adolescents and Young Adults: In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included adult and pediatric patients, the incidence of suicidal thoughts and behaviors in patients age 24 years and younger was greater than in placebo-treated patients. SPRAVATO™ is not approved in pediatric (<18 years of age) patients.
There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied.
Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing SPRAVATO™ and/or the concomitant oral antidepressant, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.
Increase in Blood Pressure: SPRAVATO™ causes increases in systolic and/or diastolic blood pressure (BP) at all recommended dosages. Increases in BP peak approximately 40 minutes after SPRAVATO™ administration and last approximately 4 hours.
Approximately 8% to 17% of SPRAVATO™-treated patients experienced an increase of more than 40 mmHg in systolic BP and/or 25 mmHg in diastolic BP in the first 1.5 hours after administration at least once during the first 4 weeks of treatment. A substantial increase in blood pressure could occur after any dose administered even if smaller blood pressure effects were observed with previous administrations. SPRAVATO™ is contraindicated in patients for whom an increase in BP or intracranial pressure poses a serious risk (e.g., aneurysmal vascular disease, arteriovenous malformation, history of intracerebral hemorrhage). Before prescribing, patients with other cardiovascular and cerebrovascular conditions should be carefully assessed to determine whether the potential benefits of SPRAVATO™ outweigh its risk.
Assess BP prior to administration of SPRAVATO™. In patients whose BP is elevated prior to SPRAVATO™ administration (as a general guide: >140/90 mmHg), a decision to delay SPRAVATO™ therapy should be taken into account to balance the benefit and risk in individual patients.
BP should be monitored for at least 2 hours after SPRAVATO™ administration. Measure blood pressure around 40 minutes post-dose and subsequently as clinically warranted until values decline. If BP remains high, promptly seek assistance from practitioners experienced in BP management. Refer patients experiencing symptoms of a hypertensive crisis (e.g., chest pain, shortness of breath) or hypertensive encephalopathy (e.g., sudden severe headache, visual disturbances, seizures, diminished consciousness or focal neurological deficits) immediately for emergency care.
Closely monitor blood pressure with concomitant use of SPRAVATO™ with psychostimulants or monoamine oxidase inhibitors(MAOIs)[see Drug Interactions].
In patients with history of hypertensive encephalopathy, more intensive monitoring, including more frequent blood pressure and symptom assessment, is warranted because these patients are at increased risk for developing encephalopathy with even small increases in blood pressure.
Cognitive Impairment
Short-Term Cognitive Impairment: In a study in healthy volunteers, a single dose of SPRAVATO™ caused cognitive performance decline 40 minutes post-dose. SPRAVATO™-treated subjects required a greater effort to complete the cognitive tests at 40 minutes post-dose. Cognitive performance and mental effort were comparable between SPRAVATO™ and placebo at 2 hours post-dose. Sleepiness was comparable after 4 hours post-dose.
Long-Term Cognitive Impairment:  Long-term cognitive and memory impairment have been reported with repeated ketamine misuse or abuse. No adverse effects of SPRAVATO™ nasal spray on cognitive functioning were observed in a one-year open-label safety study; however, the long-term cognitive effects of SPRAVATO™ have not been eva luated beyond one year.
Impaired Ability to Drive and Operate Machinery: Before SPRAVATO™ administration, instruct patients not to engage in potentially hazardous activities requiring complete mental alertness and motor coordination, such as driving a motor vehicle or operating machinery, until the next day following a restful sleep. Patients will need to arrange transportation home following treatment with SPRAVATO™.
Ulcerative or Interstitial Cystitis: Cases of ulcerative or interstitial cystitis have been reported in individuals with long-term off-label use or misuse/abuse of ketamine. In clinical studies with SPRAVATO™ nasal spray, there was a higher rate of lower urinary tract symptoms (pollakiuria, dysuria, micturition urgency, nocturia, and cystitis) in SPRAVATO™-treated patients than in placebo-treated patients. No cases of esketamine-related interstitial cystitis were observed in any of the studies, which involved treatment for up to a year.
Monitor for urinary tract and bladder symptoms during the course of treatment with SPRAVATO™ and refer to an appropriate healthcare provider as clinically warranted.
Embryo-fetal Toxicity: SPRAVATO™ may cause fetal harm when administered to pregnant women. Advise pregnant women of the potential risk to an infant exposed to SPRAVATO™ in utero. Advise women of reproductive potential to consider pregnancy planning and prevention.
DRUG INTERACTIONS
CNS depressants (e.g.benzodiazepines, opioids, alcohol): Concomitant use may increase sedation. Closely monitor for sedation with concomitant use of CNS depressants.
Psychostimulants (e.g.amphetamines, methylphenidate, modafinil, armodafinil): Concomitant use may increase blood pressure. Closely monitor blood pressure with concomitant use of psychostimulants.
Monoamine oxidase inhibitors (MAOIs): Concomitant use may increase blood pressure. Closely monitor blood pressure with concomitant use of MAOIs.
USE IN SPECIFIC POPULATIONS
Pregnancy: SPRAVATO™ is not recommended during pregnancy. SPRAVATO™ may cause fetal harm when administered to pregnant women. Advise pregnant women of the potential risk to an infant exposed to SPRAVATO™ in utero. There are risks to the mother associated with untreated depression in pregnancy. If a woman becomes pregnant while being treated with SPRAVATO™, treatment with SPRAVATO™ should be discontinued and the patient should be counseled about the potential risk to the fetus.
Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including SPRAVATO™, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
Lactation: SPRAVATO™ is present in human milk. Because of the potential for neurotoxicity, advise patients that breastfeeding is not recommended during treatment with SPRAVATO™.
Females and Males of Reproductive Potential: SPRAVATO™ may cause embryo-fetal harm when administered to a pregnant woman. Consider pregnancy planning and prevention for females of reproductive potential during treatment with SPRAVATO™.
Pediatric Use: The safety and effectiveness of SPRAVATO™ in pediatric patients have not been established.
Geriatric Use: Of the total number of patients in Phase 3 clinical studies exposed to SPRAVATO™, 12% were 65 years of age and older, and 2% were 75 years of age and older. No overall differences in the safety profile were observed between patients 65 years of age and older and patients younger than 65 years of age.
The mean esketamine Cmax and AUC values were higher in elderly patients compared with younger adult patients.
The treatment of TRD in geriatric patients was eva luated in a 4-week, randomized, double-blind study comparing flexibly-dosed intranasal SPRAVATO™ plus a newly initiated oral antidepressant compared to intranasal placebo plus a newly initiated oral antidepressant in patients ≥65 years of age. At the end of four weeks, there was no statistically significant difference between groups on the primary efficacy endpoint of change from baseline to Week 4 on the Montgomery-Åsberg Depression Rating Scale (MADRS).
Hepatic Impairment: SPRAVATO™-treated patients with moderate hepatic impairment may need to be monitored for adverse reactions for a longer period of time.
SPRAVATO™ has not been studied in patients with severe hepatic impairment (Child-Pugh class C). Use in this population is not recommended.
DRUG ABUSE AND DEPENDENCE
Controlled Substance: SPRAVATO™ contains esketamine hydrochloride, the (S)-enantiomer of ketamine and a Schedule III controlled substance under the Controlled Substances Act.
Abuse: Individuals with a history of drug abuse or dependence may be at greater risk for abuse and misuse of SPRAVATO™. Abuse is the intentional, non-therapeutic use of a drug, even once, for its psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Careful consideration is advised prior to use of individuals with a history of substance use disorder, including alcohol.
SPRAVATO™ may produce a variety of symptoms including anxiety, dysphoria, disorientation, insomnia, flashback, hallucinations, and feelings of floating, detachment and to be “spaced out.” Monitoring for signs of abuse and misuse is recommended.
ADVERSE REACTIONS
The most common adverse reactions with SPRAVATO™ plus oral AD (incidence ≥5% and at least twice that of placebo nasal spray plus oral AD) were dissociation, dizziness, nausea, sedation, vertigo, hypoesthesia, anxiety, lethargy, blood pressure increased, vomiting, and feeling drunk.  

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