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  药店国别: 日本药房
产地国家: 日本
所属类别: 抗癌药物->治疗骨髓瘤药物
处方药:处方药
包装规格: 2.3毫克/片, 1片/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
武田薬品工業株式会社
生产厂家英文名:
Takeda Pharmaceutical Company Limited
该药品相关信息网址1:
http://www.takedaoncology.com/medicines/ninlaro
该药品相关信息网址2:
https://en.wikipedia.org/wiki/Ixazomib
该药品相关信息网址3:
https://www.takeda.com/jp/newsroom/newsreleases/2015/20151121_7186
原产地英文商品名:
NINLARO capsules 2.3mg
原产地英文药品名:
ixazomib
中文参考商品译名:
NINLARO®胶囊 2.3毫克 (口服蛋白酶体抑制剂)
中文参考药品译名:
ixazomib
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Multiple myeloma
临床试验期:
完成
中文适应病症参考翻译1:
多发性骨髓瘤
药品信息:

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 详细处方信息以本药内容附件PDF文件(201892518524628.pdf)的“原文Priscribing Information”为准
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部分NINLARO处方资料(仅供参考)

NINLARO关于NINLARO(ixazomib)胶囊

NINLARO (ixazomib)是首个也是唯一的口服蛋白酶体抑制剂,其适应证是联合来那度胺和地塞米松用于治疗先前至少用过一种药物的多发性骨髓瘤患者。NINLARO每周一次口服,分别在28天周期的第1、8、15、28天给药。NINLARO目前正在欧洲药品管理局(EMA)审批中,并已获得人用药品委员会(CHMP)的加快评审。2014年,NINLARO还被美国FDA认可为用于复发或难治全身性轻链(AL)淀粉样变(一种相关的超级孤儿病)的突破性治疗药物。

NINLARO®(ixazomib)胶囊,为口服使用

适应证和用途

NINLARO是一个蛋白体抑制剂适用与来那度胺和地塞米松联用为有多发性骨髓瘤患者曽接受至少一种以前治疗的治疗。(1) 剂量和给药方法

⑴ 推荐起始剂量4mg口服在28-天疗程的第1,8,和15天。

⑵ 剂量应被服用食物前至少一小时或后至少2小时。

剂型和规格

胶囊:4mg,3mg,和2.3mg

禁忌证

无。

警告和注意事项

⑴ 血小板减少:治疗期间监视血小板计数至少每月和调整,当需要时。

⑵ 胃肠道毒性:对严重腹泻,便秘,恶心,和呕吐,当需要时调整给药。

⑶ 外周神经病变:监视患者外周神经病变的症状和调整给药,当需要时。

⑷ 外周水肿:监视液体潴留。研究潜在原因,当适当。调整给药,当需要时。

⑸ 皮肤反应:监视患者皮疹和调整给药,当需要时。

⑹ 肝毒性:治疗期间监视肝酶。

⑺ 胚胎胎儿毒性:NINLARO可能致胎儿危害。忠告生殖潜能女性和使用有效避孕。

不良反应

最常见不良反应(≥ 20%)是腹泻,便秘,血小板减少,外周神经病变,恶心,外周水肿,呕吐,和背痛。(6.1)

药物相互作用

强CYP3A诱导剂:避免与NINLARO同时使用。

特殊人群中使用

⑴ 肝受损:在有中度或严重肝受损患者减低NINLARO开始剂量至3 mg。

⑵ 肾受损:有严重肾受损或肾病终末期需要透析患者减低NINLARO开始剂量至3 mg。

哺乳:终止哺乳。

完整处方资料

1 适应证和用途

NINLARO是适用与来那度胺和地塞米松联用为有多发性骨髓瘤曽接受至少一次以前治疗患者的治疗。

2 剂量和给药方法

2.1 给药和给药指导

NINLARO与来那度胺和地塞米松联用

NINLARO的推荐起始剂量是4 mg给予口服一周1次在28-天疗程第1,8,和15天。.

来那度胺的推荐起始剂量是25 mg给予每天28-天治疗疗程第1天至21天。

地塞米松的推荐起始剂量是40 mg给予在28-天治疗疗程的第1,8,15,和22天。

对关于来那度胺和地塞米松另外资料,参阅它们的处方资料。

NINLARO应被服用一周1次对第一个四周疗程的头三周的相同天和在接近相同时间。

NINLARO应在食物前至少1小时或后至少2小时服用[见临床药理学(12.3)]。应与水整吞胶囊。胶囊不应被压碎,咀嚼或打开[见如何供应/贮存和处置(16.3)]。 如一次NINLARO剂量被延迟或缺失,只有如时间表下一次是 ≥ 72 小时外才应服用该剂量。在下一次时间表剂量72小时内不应服用一个缺失剂量。对缺失剂量不应服用双重剂量组成。

如果服用一剂后发生呕吐,患者不应重复该剂量。患者应在下一个时间表剂量时恢复给药。

开始一个新治疗疗程前:

● 绝对中性粒细胞计数应是至少1,000/mm3

● 血小板计数应是至少75,000/mm3

● 非血液学毒性应在医生分辨,一般地恢复至患者的基线条件或1级或以下治疗应被继续直至 疾病 进展或不可接受毒性。

2.3 有肝受损患者中剂量

在有中度(总胆红素大于1.5-3 × ULN)或严重(总胆红素大于3 × ULN)肝受损患者减低NINLARO开始剂量至3 mg [见特殊人群中使用(8.6)和临床药理学(12.3)]。

2.4 有肾受损患者中剂量

在有严重肾受损(肌酐清除率低于30 mL/min)或肾病终末期(ESRD)需要透析患者中减低NINLARO开始剂量至3 mg。NINLARO是不能透析的和因此可给予不考虑透析时间[见特殊人群中使用(8.7)和临床药理学(12.3)]。 对在有肾受损患者给药推荐参阅来那度胺处方资料。

3 剂型和规格

可得到以下胶囊强度的NINLARO:

● 4mg:浅橙色明胶胶囊用嘿墨汁在帽上印有“Takeda”和在提上“4.0mg”。NINLARO 4mg胶囊含4mg的ixazomib等同于5.7 mg的ixazomib柠檬酸盐。

● 3mg:浅灰色明胶胶囊在帽上用嘿墨汁印有“Takeda”和提上“3.0mg”。NINLARO 3mg胶囊含3 mg的ixazomib等同于4.3mg的ixazomib柠檬酸盐。

● 2.3mg:浅粉红色明胶胶囊用黑墨汁在帽上印有“Takeda”和在体上“2.3mg”。NINLARO 2.3mg胶囊含2.3mg的ixazomib等同于3.3mg的ixazomib柠檬酸盐。

4 禁忌证

无。

5 警告和注意事项

5.1 血小板减少

曽报道用NINLARO血小板减少,有血小板最低值典型地发生在每个28-天疗程第14-21天间和至下一个疗程开始恢复至基线。在NINLARO方案中3%患者和在安慰剂方案中1%患者治疗期间有一个血小板计数≤ 10,000/mm3。在两个方案治疗期间都有低于1%患者有一个血小板计数≤ 5000/mm3。两个方案由于血小板减少终止是相似(在NINLARO方案中< 1%患者和在安慰剂方案中2%患者终止三个药物的一个或更多)。在NINLARO方案中血小板输注率为6%和在安慰剂方案中5%。 用NINLARO治疗期间监视血小板计数至少每月。在头三个疗程考虑更频监视。用剂量调整处理血小板减少[见剂量和给药方法(2.2)]和血小板输注作为每个标准医疗指导。

5.2 胃肠道毒性

用NINLARO曽报道腹泻,便秘,恶心,和呕吐,偶然地需要使用抗腹泻药和抗呕吐药,和支持性医护。在NINLARO方案中报道腹泻42%患者和在安慰剂方案中36%,便秘分别34%和25%,恶心分别为26%和21%,和呕吐分别为22%和11%。在NINLARO方案中腹泻导致1% of患者三个药物终止一个或更多和在安慰剂方案中< 1%患者。对 3或4级症状调整给药[见剂量和给药方法(2.2)]。

5.3 外周神经病变

外周神经病变不良反应的多数为1级(在NINLARO方案中18%和在安慰剂方案中14%)和2级(在NINLARO方案中8%和在安慰剂方案中5%)。两个方案报道外周神经病变的3级不良反应都是2%;没有4级或严重不良反应。

最常报道反应是周边感觉神经病变(在NINLARO和安慰剂方案分别为19%和14%)。在任一方案都不常报道(< 1%)周边运动神经病变。在两个方案中都有1%患者外周神经病变导致终止三个药物的一个或更多。患者应被监视神经病变症状。患者经受新外周神经病变或恶化可能需要剂量调整[见剂量和给药方法(2.2)]。

5.4 外周水肿

在NINLARO和安慰剂方案分别有25%和18%患者报道外周水肿。外周水肿不良反应的多数是1级(在NINLARO方案中16%和在安慰剂方案中13%)和2级(在NINLARO方案中7%和在安慰剂方案中4%)。 在NINLARO和安慰剂方案分别报道在2%和1%患者的3级外周水肿。没有报道4级外周水肿。没有由于外周水肿终止药物的报道。评价潜在原因和需要时提供支持性医护。对3或4级症状按地塞米松或NINLARO的处方资料调整给药[见剂量和给药方法(2.2)]。

5.5 皮肤反应

在NINLARO方案中19%患者报道皮疹和在安慰剂方案中11%患者。the 皮疹不良反应的多数是1级(在NINLARO方案中10%和在安慰剂方案中7%)或2级(在NINLARO方案中6%和在安慰剂方案中3%)。在NINLARO方案中3%患者报道3级皮疹和在安慰剂方案中1%患者。没有报道皮疹的4级或严重不良反应。在两个方案最常报道的皮疹类型包括斑丘疹和红斑疹。在两个方案中皮疹导致< 1%患者三个药物的一个或更多终止。如2级或更高用支持性医护或用剂量调整处理皮疹[见剂量和给药方法(2.2)]。

5.6 肝毒性

药物-诱导肝损伤,肝细胞损伤,脂肪肝,淤胆型肝炎和肝毒性各种曽在< 1%用NINLARO治疗患者报道。曽报道肝受损事件(在NINLARO方案中6%和在安慰剂方案中5%)。对3或4级症状监视调节地肝酶和调整给药[见剂量和给药方法(2.2)]。

5.7 胚胎胎儿毒性

当给予至一例妊娠妇女根据作用机制和在动物中发现NINLARO可能致胎儿危害。在妊娠妇女中没有用NINLARO适当和well-对照良好研究。在妊娠大鼠和兔在剂量导致暴露略微较高于在接受推荐剂量患者观察到暴露Ixazomib致胚胎胎儿毒性。 生殖潜能女性应被忠告当正在用NINLARO治疗避免成为妊娠。如妊娠期间被使用NINLARO或如当正在用NINLARO患者成为妊娠,患者应被忠告对胎儿潜在危害。忠告生殖潜能女性用NINLARO治疗期间和最终剂量后共90天她们必须使用有效避孕[见特殊人群中使用(8.1,8.3)和非临床毒理学(13.1)]。

6 不良反应

处方资料的其他节中详细描述以下不良反应:

● 血小板减少[见警告和注意事项(5.1)]

● 胃肠道毒性[见警告和注意事项(5.2)]

● 外周神经病变[见警告和注意事项(5.3)]

● 外周水肿[见警告和注意事项(5.4)]

● 皮肤反应[见警告和注意事项(5.5)]

● 肝毒性[见警告和注意事项(5.6)]

贮存

NINLARO 可能被贮藏在室温。不要高于30°C(86°F)。不要冻结。贮藏胶囊在原始包装直至直至用前立即。

处置和遗弃

NINLARO是细胞毒性1。胶囊不应被打开或压碎。应避免直接接触胶囊内容物。在胶囊破裂情况中,避免胶囊内容物与皮肤或眼直接接触。如发生与皮肤接触,用肥皂和水彻底洗涤。如发生与眼接触,用水彻底地冲洗。

任何未使用药物产品或废料应按照当地要求遗弃。

NINLARO about NINLARO (ixazomib) capsules

NINLARO (ixazomib) is the first and only oral proteasome inhibitor with indications for the combination of lenalidomide and dexamethasone for the treatment of multiple myeloma patients who have previously used at least one drug. NINLARO was administered orally once a week and administered on days 1, 8, 15, and 28 of the 28-day cycle, respectively. NINLARO is currently under review by the European Medicines Agency (EMA) and has been accredited by the Human Drugs Committee (CHMP). In 2014, NINLARO was also recognized by the US FDA as a breakthrough treatment for relapsed or refractory systemic light chain (AL) amyloidosis, a related super orphan disease.

NINLARO® (ixazomib) capsule for oral use

Indications and Uses

NINLARO is a proteosome inhibitor for use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior treatment. (1) Dosage and method of administration

(1) The recommended starting dose of 4 mg is administered orally on days 1, 8, and 15 of the 28-day course.

(2) The dose should be at least one hour before or at least 2 hours after taking the food.

Formulations and specifications

Capsules: 4mg, 3mg, and 2.3mg

Contraindications

No.

Warnings and precautions

(1) Thrombocytopenia: Monitor platelet counts at least monthly and adjusted during treatment, when needed.

(2) Gastrointestinal toxicity: For severe diarrhea, constipation, nausea, and vomiting, adjust the dose when needed.

(3) Peripheral neuropathy: Monitor the symptoms of peripheral neuropathy in patients and adjust dosing when needed.

(4) Peripheral edema: Monitor fluid retention. Study the underlying causes when appropriate. Adjust the dosing when needed.

(5) Skin reactions: Monitor patient rashes and adjust dosing when needed.

(6) Hepatotoxicity: Monitor liver enzymes during treatment.

(7) Embryonic fetal toxicity: NINLARO may cause fetal harm. Advise women with reproductive potential and use effective contraception.

Adverse reactions

The most common adverse reactions (≥ 20%) were diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, and back pain. (6.1)

Drug interaction

Strong CYP3A inducer: Avoid simultaneous use with NINLARO.

Use

in special people

(1) Hepatic impairment: Reduce the starting dose of NINLARO to 3 mg in patients with moderate or severe hepatic impairment.

(2) Kidney damage: Patients with severe kidney damage or end stage renal disease requiring dialysis reduce the starting dose of NINLARO to 3 mg.

Breastfeeding: Stop breastfeeding.

Complete prescription information

1 Indications and Uses

NINLARO is a combination of lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one previous treatment.

2 Dosage and administration method

2.1 Guidance on administration and administration

NINLARO in combination with lenalidomide and dexamethasone

The recommended starting dose for NINLARO is 4 mg administered orally once a week for the first, eighth, and fifth days of the 28-day course. .

The recommended starting dose of lenalidomide is 25 mg administered daily from day 1 to day 21 for 28-day treatment.

The recommended starting dose for dexamethasone is 40 mg administered on days 1, 8, 15, and 22 of the 28-day course of treatment.

For additional information on lenalidomide and dexamethasone, see their prescription information.

NINLARO should be taken once a week for the first three weeks of the first four weeks of the same day and at approximately the same time.

NINLARO should be taken at least 1 hour before or after food (see Clinical Pharmacology (12.3)]. The capsule should be swallowed with water. Capsules should not be crushed, chewed or opened [see How to Supply/Storage and Disposal (16.3)]. If a dose of NINLARO is delayed or missing, the dose should only be taken if the schedule is next ≥ 72 hours. A missing dose should not be taken within 72 hours of the next scheduled dose. Do not take a double dose for the missing dose.

If vomiting occurs after taking one dose, the patient should not repeat the dose. The patient should resume administration at the next scheduled dose.

Before starting a new treatment:

● The absolute neutrophil count should be at least 1,000/mm3

● The platelet count should be at least 75,000/mm3

● Non-hematologic toxicity should be resolved by the physician and generally returned to the patient's baseline condition or treatment at level 1 or below should continue until disease progression or unacceptable toxicity.

2.3 Dosage in patients with hepatic impairment

In patients with hepatic impairment with moderate (total bilirubin greater than 1.5-3 × ULN) or severe (total bilirubin greater than 3 × ULN), reduce the starting dose of NINLARO to 3 mg [see Special Population Use (8.6) and Clinical Pharmacology (12.3)].

2.4 Dosage in patients with renal impairment

Reduce the starting dose of NINLARO to 3 mg in patients with severe renal impairment (creatinine clearance below 30 mL/min) or end stage renal disease (ESRD). NINLARO is not dialysis and can therefore be given regardless of dialysis time [see Use in Special Populations (8.7) and Clinical Pharmacology (12.3)]. Refer to the lenalidomide prescription for administration to patients with renal impairment.

3 dosage forms and specifications

The following capsule strengths are available for NINLARO:

● 4mg: Light orange gelatin capsules are printed with “Takeda” on the cap and “4.0mg” on the cap. NINLARO 4 mg capsules contain 4 mg of ixazomib equivalent to 5.7 mg of ixazomib citrate.

● 3mg: Light gray gelatin capsules are printed with “Takeda” and “3.0mg” on the cap with ink. NINLARO 3 mg capsules contain 3 mg of ixazomib equivalent to 4.3 mg of ixazomib citrate.

● 2.3mg: Light pink gelatin capsules with black ink are printed on the cap with "Takeda" and on the body "2.3mg". NINLARO 2.3 mg capsules contain 2.3 mg of ixazomib equivalent to 3.3 mg of ixazomib citrate.

4 Contraindications

no.

5 Warnings and Precautions

5.1 Thrombocytopenia

曽 Reported with NINLARO thrombocytopenia, the lowest platelet count typically occurs between days 14-21 of each 28-day course and begins to return to baseline by the next course of treatment. One platelet count ≤ 10,000/mm3 during treatment in 3% of patients in the NINLARO regimen and 1% in the placebo regimen. Less than 1% of patients had a platelet count ≤ 5000/mm3 during both regimens. Both regimens were similar due to thrombocytopenic termination (< 1% of patients in the NINLARO regimen and 2% of patients in the placebo regimen discontinued one or more of the three drugs). The platelet transfusion rate was 6% in the NINLARO regimen and 5% in the placebo regimen. Monitor platelet counts at least monthly during treatment with NINLARO. Consider more frequent monitoring during the first three sessions. Dose adjustment was used to treat thrombocytopenia [see Dosage and Administration (2.2)] and platelet transfusion as per standard medical guidance.

5.2 Gastrointestinal toxicity

Reporting diarrhea, constipation, nausea, and vomiting with NINLARO曽, occasionally requires anti-diarrheal and anti-emetic medications, and supportive care. In the NINLARO protocol, 42% of patients with diarrhea and 36% of patients in the placebo regimen, 34% and 25% of constipation, 26% and 21% of nausea, and 22% and 11% of vomiting, respectively, were reported. In the NINLARO regimen, diarrhea resulted in 1% of patients discontinuing one or more of the three drugs and <1% of patients in the placebo regimen. Administration of grade 3 or 4 symptom adjustment [see Dosage and Administration (2.2)].

5.3 Peripheral neuropathy

The majority of adverse effects of peripheral neuropathy were grade 1 (18% in the NINLARO regimen and 14% in the placebo regimen) and grade 2 (8% in the NINLARO regimen and 5% in the placebo regimen). Both protocols reported a grade 3 adverse event for peripheral neuropathy of 2%; no grade 4 or serious adverse events.

The most frequently reported response was peripheral sensory neuropathy (19% and 14% in the NINLARO and placebo regimens, respectively). Peripheral motor neuropathy is rarely reported (< 1%) in either regimen. In both protocols, 1% of patients with peripheral neuropathy resulted in the termination of one or more of the three drugs. Patients should be monitored for neuropathy symptoms. Patients undergoing new peripheral neuropathy or worsening may require dose adjustment [see Dosage and Administration (2.2)].

5.4 Peripheral edema

Peripheral edema was reported in 25% and 18% of patients in the NINLARO and placebo regimens, respectively. The majority of adverse effects of peripheral edema were grade 1 (16% in the NINLARO regimen and 13% in the placebo regimen) and grade 2 (7% in the NINLARO regimen and 4% in the placebo regimen). Grade 3 peripheral edema was reported in 2% and 1% of patients in the NINLARO and placebo regimens, respectively. No grade 4 peripheral edema was reported. There were no reports of discontinuation of the drug due to peripheral edema. Provide supportive care when evaluating potential causes and needs. The administration of grade 3 or 4 symptoms was adjusted according to the prescription of dexamethasone or NINLARO [see Dosage and Administration (2.2)].

5.5 Skin reaction

In the NINLARO regimen, 19% of patients reported rash and 11% of patients in the placebo regimen. The majority of the rash adverse reactions were grade 1 (10% in the NINLARO regimen and 7% in the placebo regimen) or grade 2 (6% in the NINLARO regimen and 3% in the placebo regimen). In the NINLARO regimen, 3% of patients reported grade 3 rash and 1% of patients in the placebo regimen. No grade 4 or serious adverse reactions to the rash were reported. The types of rash most commonly reported in both programs include maculopapular rash and red spot rash. In both regimens the rash caused <1% of patients to terminate one or more of the three drugs. For example, level 2 or higher with supportive care or dose adjustment for rash [see Dosage and Administration (2.2)].

5.6 Hepatotoxicity

Drug-induced liver damage, liver cell damage, fatty liver, cholestatic hepatitis and hepatotoxicity were reported in patients treated with NINLARO at <1%.肝 Reported liver damage events (6% in the NINLARO regimen and 5% in the placebo regimen). Monitor liver enzymes and adjust dosing for grade 3 or 4 symptom monitoring [see Dosage and Administration (2.2)].

5.7 Embryo Fetal Toxicity

When given to a pregnant woman, depending on the mechanism of action and the discovery of NINLARO in animals, it may cause fetal harm. There was no good and well-controlled good study with NINLARO in pregnant women. In pregnant rats and rabbits, the dose-induced exposure was slightly higher than that observed in patients receiving the recommended dose of Ixazomib-induced embryonic fetal toxicity. Women with reproductive potential should be advised when they are being treated with NINLARO to avoid becoming a pregnancy. If NINLARO is used during pregnancy or if a patient is being pregnant with NINLARO, the patient should be advised of potential harm to the fetus. Advice for reproductive potential Women must use effective contraception for 90 days after NINLARO treatment and after the final dose [see Use in Special Populations (8.1, 8.3) and Non-Clinical Toxicology (13.1)].

6 Adverse reactions

The following adverse reactions are described in detail in other sections of the prescribing data:

● Thrombocytopenia [see Warnings and Precautions (5.1)]

● Gastrointestinal toxicity [see Warnings and Precautions (5.2)]

● Peripheral neuropathy [see Warnings and Precautions (5.3)]

● Peripheral edema [see Warnings and Precautions (5.4)]

● Skin reactions [see Warnings and Precautions (5.5)]

● Hepatotoxicity [see Warnings and Precautions (5.6)]

Storage

NINLARO may be stored at room temperature. Do not exceed 30 ° C (86 ° F). Do not freeze. The storage capsules are in the original packaging until immediately before use.

Disposal and Abandonment

NINLARO is cytotoxic 1 . The capsule should not be opened or crushed. Direct contact with the contents of the capsule should be avoided. In the event of a ruptured capsule, the capsule contents are prevented from coming into direct contact with the skin or eyes. If contact with skin occurs, wash thoroughly with soap and water. Rinse thoroughly with water if eye contact occurs.

Any unused pharmaceutical product or waste should be disposed of in accordance with local requirements.

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 详细处方信息以本药内容附件PDF文件(201892518524628.pdf)的“Prescribing Information”为准
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更新日期: 2018-03-27
附件:
201892518524628.pdf    

 
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